Healthcare Sales & Marketing Network News: nausea

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HSMN NewsFeed - 11 May 2026
Partner Therapeutics Announces FDA Approval of BIZENGRI(R) (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner's National Priority Voucher
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 13 Apr 2026
Lilly's Jaypirca (Pirtobrutinib) Significantly Extended Progression-Free Survival When Added to a Venetoclax Time-Limited Regimen in Patients with Previously Treated CLL/SLL
Biopharmaceuticals Oncology

HSMN NewsFeed - 27 Mar 2026
Otsuka Pharmaceutical to Acquire Transcend Therapeutics
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 4 Mar 2026
First-in-Human Use of CereVasc(R) eShunt(R) System in Idiopathic Intracranial Hypertension Demonstrates Sustained Clinical Outcomes
Devices Neurosurgery

HSMN NewsFeed - 22 Dec 2025
U.S. FDA Approves JASCAYD(R) (nerandomilast) Tablets for the Treatment of Progressive Pulmonary Fibrosis in Adults
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Dec 2025
BioMarin to Acquire Amicus Therapeutics for $4.8 Billion, Expanding Position as a Leader in Rare Diseases, Accelerating Revenue Growth and Strengthening Financial Outlook
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 28 Nov 2025
Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Aug 2025
Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jan 2025
FDA Approves LUMAKRAS(R) (Sotorasib) in Combination with Vectibix(R) (Panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Oct 2024
Protega Pharmaceuticals Receives FDA Approval for ROXYBOND(TM) (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Oct 2024
ShiraTronics Raises $66 Million in Oversubscribed Series B Financing to Advance Pioneering Treatment for Chronic Migraine
Devices Neurology Venture Capital

HSMN NewsFeed - 19 Sep 2024
FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Sep 2024
Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI(TM) (trastuzumab-strf), a biosimilar to Herceptin(R) (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer
Biopharmaceuticals Generics Oncology FDA

HSMN NewsFeed - 20 Aug 2024
RYBREVANT(R) (amivantamab-vmjw) Plus LAZCLUZE(TM) (lazertinib) Approved in the U.S. as a First-line Chemotherapy-free Treatment for Patients with EGFR-mutated Advanced Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Aug 2024
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 28 Jun 2024
AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY(R)) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Jun 2024
Harmony Biosciences Receives U.S. Food And Drug Administration Approval For Wakix(R) (Pitolisant) In Pediatric Patients With Narcolepsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 26 Mar 2024
Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS(R)
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 11 Mar 2024
FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA(R) (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Mar 2024
U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 12 Feb 2024
AbbVie Completes Acquisition of ImmunoGen
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 26 Dec 2023
Amgen Provides Regulatory Update on Status of Lumakras(R) (Sotorasib)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Oct 2023
Amgen Completes Acquisition of Horizon Therapeutics plc
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 26 Sep 2023
Gensco(R) Pharma Announces RizaFilm(R) Commercialization Update in the United States
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 17 Aug 2023
AbbVie Announces European Commission Approval of AQUIPTA(R) (atogepant) for the Preventive Treatment of Migraine in Adults
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 13 Jun 2023
VA Oklahoma City Healthcare System Chooses ViewRay's MRIdian(R) MRI-Guided Radiation Therapy System
Devices Oncology

HSMN NewsFeed - 9 Jun 2023
Astellas Submits New Drug Application for Zolbetuximab in Japan
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Apr 2023
Lilly to Divest BAQSIMI to Amphastar
Biopharmaceuticals Endocrinology Mergers & Acquisitions

HSMN NewsFeed - 21 Apr 2023
AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA(R)) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 AAN Annual Meeting
Biopharmaceuticals Neurology

HSMN NewsFeed - 2 Mar 2023
Siteman Cancer Center at Washington University Treats 2,000th Patient with MRIdian(R) MRI-Guided Radiation Therapy
Devices Oncology

HSMN NewsFeed - 23 Nov 2022
BioMarin Announces Advancements in FDA Review of ROCTAVIAN(TM) (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Nov 2022
U.S. Food and Drug Administration Approves CSL's Hemgenix(R) eEtranacogene dezaparvovec-drlb), the First Gene Therapy for Hemophilia B
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Oct 2022
ViewRay Announces Primary Endpoint Outcome from First Prospective, Multi-Institutional Study to Deliver Ablative Doses of Radiation to Pancreatic Cancer Patients
Devices Oncology

HSMN NewsFeed - 26 Sep 2022
Innocoll and DURECT Announce U.S. launch of POSIMIR(R)
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 20 Sep 2022
MD Anderson Cancer Center Selects ViewRay to Expand MR-Guided Radiation Therapy Program
Devices Oncology

HSMN NewsFeed - 8 Sep 2022
GenesisCare Purchases Two Additional ViewRay MRIdian MRI-guided Radiotherapy Systems for Guildford and Birmingham Projects, Doubling United Kingdom Footprint to Four Systems
Devices Oncology

HSMN NewsFeed - 7 Sep 2022
ViewRay Announces China NMPA Approval of its MRIdian(R) MRI-Guided Radiation Therapy for Cancer Patients
Devices Oncology Regulatory

HSMN NewsFeed - 23 Aug 2022
VA Houston Healthcare System Selects ViewRay to Expand Advanced Radiation Therapy Services
Devices Oncology

HSMN NewsFeed - 4 Aug 2022
Amgen to Acquire Chemocentryx for $4 Billion in Cash
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 21 Jul 2022
Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO(R) (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 19 Jul 2022
Saitama Medical University International Medical Center Selects MRIdian(R) MRI-Guided Radiation Therapy System
Devices Oncology

HSMN NewsFeed - 24 Jun 2022
BioMarin Receives Positive CHMP Opinion in Europe for Valoctocogene Roxaparvovec Gene Therapy to Treat Adults with Severe Hemophilia A
Biopharmaceuticals Regulatory

HSMN NewsFeed - 9 Jun 2022
VA Ann Arbor Healthcare System Selects ViewRay to Expand Advanced Radiation Therapy Services
Devices Oncology

HSMN NewsFeed - 7 Jun 2022
Shin-Matsudo Central General Hospital Select's ViewRay's MRIdian(R) MRI-Guided Radiation Therapy System to Expand Access to Precision Radiation Therapy
Devices Oncology

HSMN NewsFeed - 2 Jun 2022
Henry Ford Health Becomes the First Center to Treat Patients with ViewRay's MRIdian A3i System
Devices Oncology

HSMN NewsFeed - 27 May 2022
Accord Healthcare Adds Pemetrexed Lyo. Injection to Generic Drug Portfolio
Biopharmaceuticals Generics Oncology Product Launch

HSMN NewsFeed - 3 May 2022
UCI Health Adopts ViewRay(R) MRIdian(R) MRI-Guided Radiation Therapy System
Devices Oncology

HSMN NewsFeed - 6 Apr 2022
FDA approves Novartis Vijoice(R) (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Mar 2022
Jazz Pharmaceuticals Announces Agreement to Divest Sunosi(R) (solriamfetol) to Axsome Therapeutics
Biopharmaceuticals Neurology Acquisitions

HSMN NewsFeed - 15 Mar 2022
University Hospital Agostino Gemelli Treats its 1,000th Patient Using MRIdian(R) MRI-Guided Radiation Therapy
Devices Oncology

HSMN NewsFeed - 28 Feb 2022
After Successful Launch of Titan SGS(R) Surgical Stapler, Standard Bariatrics, Inc. Achieves Final Series B Funding Early
Devices Surgery Venture Capital

HSMN NewsFeed - 25 Feb 2022
Biohaven and Pfizer Receive Positive CHMP Opinion for Migraine Treatment
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 14 Feb 2022
Biohaven and Pfizer Announce Positive Topline Results of Pivotal Trial of Rimegepant for the Acute Treatment of Migraine in China and South Korea
Biopharmaceuticals Neurology

HSMN NewsFeed - 19 Jan 2022
Titan SGS(R) from Standard Bariatrics, Inc. Passes 1,000 Clinical Case Uses
Devices Surgery

HSMN NewsFeed - 13 Jan 2022
PANTHERx Rare(R) Selected by Xeris Pharmaceuticals to Distribute Recorlev(R) (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients with Cushing's Syndrome
Biopharmaceuticals Distribution

HSMN NewsFeed - 15 Dec 2021
ViewRay Receives 510(k) Clearance on Next Generation of MRIdian MRI-Guided Radiation Therapy Features
Devices Oncology FDA

HSMN NewsFeed - 24 Nov 2021
ViewRay Announces MRIdian MR-Guided Radiation Therapy Surpasses 2,300 Pancreatic Cancer Patients Treated Worldwide
Devices Oncology

HSMN NewsFeed - 19 Nov 2021
BioMarin Receives FDA Approval for VOXZOGO(TM) (vosoritide) for Injection, Indicated to Increase Linear Growth in Children with Achondroplasia Aged 5 and Up with Open Growth Plates
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Nov 2021
NURTEC(R) ODT Approved In Kuwait For Acute Treatment Of Migraine
Biopharmaceuticals Regulatory

HSMN NewsFeed - 25 Oct 2021
Helsinki University Hospital Selects MRIdian(R) System for Installation at Comprehensive Cancer Center
Devices Oncology

HSMN NewsFeed - 13 Oct 2021
FDA Approves Verzenio(R) (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Sep 2021
OLUMIANT(R) Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata
Biopharmaceuticals

HSMN NewsFeed - 27 Sep 2021
Japan's MHLW Approves PADCEV(R) (enfortumab vedotin) for Advanced Urothelial Cancer
Biopharmaceuticals Urology Oncology Regulatory

HSMN NewsFeed - 16 Sep 2021
LUMAKRAS(TM) (Sotorasib) Combined With Vectibix(R) (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 24 Aug 2021
European Commission Approves RINVOQ(R) (upadacitinib) as First JAK Inhibitor in the European Union for the Treatment of Both Adults and Adolescents with Moderate to Severe Atopic Dermatitis
Biopharmaceuticals Dermatology Regulatory

HSMN NewsFeed - 6 Aug 2021
FDA Approves New Treatment for Pompe Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Aug 2021
RealView Imaging Ltd., World Leader in Medical Holography, Receives FDA Clearance for its Groundbreaking HOLOSCOPE(TM)-i Holographic System
Devices Radiology FDA

HSMN NewsFeed - 21 Jul 2021
Corium Launches Innovative ADHD Treatment AZSTARYS(TM) (serdexmethylphenidate and dexmethylphenidate) in the U.S. for Patients Age 6 Years and Older
Biopharmaceutical Neurology Product Launch

HSMN NewsFeed - 20 Jul 2021
Pharming signs agreement with NewBridge Pharmaceuticals for the commercialization of RUCONEST(R) in the Middle East and North Africa
Biopharmaceuticals Licensing Distribution

HSMN NewsFeed - 16 Jul 2021
Sandoz launches first generic high dose intravenous iron, Ferumoxytol Injection, to treat US patients with iron deficiency anemia
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 12 Jul 2021
Janssen Announces U.S. FDA Approval of DARZALEX FASPRO(R) (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Jul 2021
Heron Therapeutics Announces U.S. Commercial Launch and Availability of ZYNRELEF(TM) for the Management of Postoperative Pain for up to 72 Hours
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 30 Jun 2021
Mitsubishi Tanabe Pharma America Announces EXSERVAN(TM) (riluzole) is Now Available in the U.S. for the Treatment of ALS
Biopharmaceuticals Neurology Product Launch

HSMN NewsFeed - 25 Jun 2021
Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jun 2021
Lilly Launches Think Talk Treat Migraine(TM) to Help Improve Diagnosis and Treatment of Migraine
Biopharmaceuticals Neurology

HSMN NewsFeed - 12 May 2021
Centers for Medicare and Medicaid Services (CMS) Issues Permanent J-Code for Tolmar's FENSOLVI(R) Effective July 1, 2021
Biopharmaceuticals Reimbursement

HSMN NewsFeed - 23 Apr 2021
GLOBAL Sarcoma Therapy Now Approved for Australian Patients
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 20 Apr 2021
Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study
Biopharmaceuticals

HSMN NewsFeed - 16 Apr 2021
Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Apr 2021
United Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 26 Mar 2021
European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 Mar 2021
Emalex Biosciences Raises $35 Million in Series C Preferred Stock to Advance Tourette Syndrome and Stuttering Clinical Trials
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 17 Mar 2021
MagVenture introduces new solution to improve the ease of use for non-invasive brain stimulation
Devices Neurology Product Launch

HSMN NewsFeed - 26 Feb 2021
Lilly announces additional doses of neutralizing antibody therapy purchased by U.S. government to treat COVID-19
Biopharmaceuticals

HSMN NewsFeed - 24 Feb 2021
Clarus Therapeutics Appoints Richard 'Ric' Peterson as Chief Financial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 12 Feb 2021
The Lancet Publishes Libtayo(R) (cemiplimab) Data Showing Extended Overall Survival in Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Feb 2021
DURECT Corporation Announces U.S. FDA Approval of POSIMIR(R) For Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 25 Jan 2021
Eiger BioPharmaceuticals Announces U.S. Commercial Availability of Zokinvy(TM) (lonafarnib), the First and Only Treatment Approved for Progeria and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals Product Launch

HSMN NewsFeed - 5 Jan 2021
Sebela Pharmaceuticals Announces U.S. Launch of SUTAB(R) Tablets, An Alternative to Liquid Colonoscopy Preparation
Biopharmaceuticals Gastroenterology FDA Product Launch

HSMN NewsFeed - 23 Dec 2020
FDA Approves Bracco Diagnostics Inc.'s ProHance(R) (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years
Biopharmaceuticals Radiology FDA

HSMN NewsFeed - 17 Dec 2020
FDA Approves GSK's BENLYSTA as the First Medicine for Adult Patients with Active Lupus Nephritis in the US
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Dec 2020
BAVENCIO(R) (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 11 Dec 2020
CHMP Recommends the Approvals of RINVOQ(TM) (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis
Biopharmaceuticals Regulatory

HSMN NewsFeed - 1 Dec 2020
Novartis announces FDA approval of Xolair(R) (omalizumab) for adults with nasal polyps
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Nov 2020
Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Nov 2020
XTANDI(R) (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 3 Nov 2020
FDA Approves Updated Label for Endari(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Nov 2020
Salvia BioElectronics receives FDA Breakthrough Device Designation for innovative neurostimulation solution
Devices Neurology FDA

HSMN NewsFeed - 28 Oct 2020
Citrine Medicine Advances Efforts to Create the Very First Rare Disease Ecosystem in China Through Strategic Partnership with Bioprojet to License Exclusive Rights for the Use of Orphan Narcolepsy Therapy Wakix(R) (pitolisant)
Biopharmaceuticals Licensing

HSMN NewsFeed - 15 Oct 2020
Titan Pharmaceuticals Provides a Strategic & Corporate Update
Biopharmaceuticals Personnel

HSMN NewsFeed - 14 Oct 2020
Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX(R) (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Oct 2020
REYVOW(R) (lasmiditan) C-V Demonstrated Superior Pain Freedom At 2 Hours in At Least 2 of 3 Migraine Attacks in New Phase 3 Consistency of Effect Study
Biopharmaceuticals Neurology

HSMN NewsFeed - 25 Sep 2020
Blueprint Medicines Announces European Commission Approval of AYVAKYT(R) (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumors
Biopharmaceuticals Regulatory

HSMN NewsFeed - 18 Sep 2020
CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis
Biopharmaceuticals Dermatology Regulatory

HSMN NewsFeed - 11 Sep 2020
REYVOW(TM) (lasmiditan) C-V Demonstrated Pain Freedom from Migraine Attacks At 60 Minutes and Up to 48 Hours in New Phase 3 Study
Biopharmaceuticals Neurology

HSMN NewsFeed - 14 Aug 2020
Lupin Presents Phase 3 Data for Solosec(R) (secnidazole) Demonstrating Significant Response Rate in Female Patients with Trichomoniasis
Biopharmaceuticals

HSMN NewsFeed - 30 Jul 2020
Jardiance(R) meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase III trial in adults with and without diabetes
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 24 Jul 2020
Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options
Biopharmaceuticals Drug Delivery Regulatory

HSMN NewsFeed - 23 Jul 2020
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat
Diagnostics FDA

HSMN NewsFeed - 22 Jul 2020
Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 26 Jun 2020
Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus
Biopharmaceuticals

HSMN NewsFeed - 18 Jun 2020
Almirall Announces FDA Approval Of Updated Label For Seysara(R) (Sarecycline) Tablets
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 1 Jun 2020
Lilly's Taltz(R) (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
Biopharmaceuticals FDA

HSMN NewsFeed - 26 May 2020
Emgality(R) Shows Improvement in Work Productivity and Health and Well-Being Between Attacks in Patients with Migraine and a History of Preventive Treatment Failure
Biopharmaceuticals Neurology

HSMN NewsFeed - 19 May 2020
AllianceRx Walgreens Prime One of Only Two Specialty Pharmacies to Distribute Vyepti(TM), the First and Only Intravenous Preventive Treatment for Migraine
Biopharmaceuticals Distribution

HSMN NewsFeed - 4 May 2020
FDA Approves FENSOLVI(R) (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Apr 2020
Novartis Kymriah(R) receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma
Biopharmaceuticals Regenerative Medicine Oncology FDA

HSMN NewsFeed - 9 Apr 2020
EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO(R) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Mar 2020
Lilly's Taltz(R) (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 23 Mar 2020
Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Mar 2020
Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Mar 2020
EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study
Biopharmaceuticals Oncology

HSMN NewsFeed - 12 Mar 2020
AbbVie Receives European Commission Approval of VENCLYXTO(R) Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 19 Feb 2020
Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV(TM) (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Feb 2020
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Feb 2020
Enteris BioPharma Appoints Gary A. Shangold, MD, as Chief Medical Officer
Biopharmaceuticals Drug Delivery Personnel

HSMN NewsFeed - 7 Feb 2020
Pharvaris Appoints Peng Lu, M.D., Ph.D., as Chief Medical Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 31 Jan 2020
AbbVie Receives Positive CHMP Opinion for MAVIRET(R) (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks in Genotype 3, Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis
Biopharmaceuticals Regulatory

HSMN NewsFeed - 31 Jan 2020
AbbVie Receives Positive CHMP Opinion for VENCLYXTO(R) as a Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 29 Jan 2020
Monoferric(R) (Ferric Derisomaltose) Injection Is Approved by the US FDA for the Treatment of Iron Deficiency Anemia
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jan 2020
PANTHERx(R) Rare Pharmacy Selected by Blueprint Medicines Corporation to Distribute AYVAKIT(TM) (avapritinib) for Genomically Defined Patient Population with Rare Cancer, GIST
Biopharmaceuticals Oncology Distribution

HSMN NewsFeed - 18 Dec 2019
Lilly Announces the Launch of TRIUMPH, the First, Long-Term, Real-World Evidence Study of Emgality(R) (galcanezumab-gnlm)
Biopharmaceuticals Neurology

HSMN NewsFeed - 17 Dec 2019
Prasco launches NuvaRing(R) (etonogestrel/ethinyl estradiol vaginal ring) Authorized Generic in the United States
Biopharmaceuticals Generics Drug Delivery Product Launch

HSMN NewsFeed - 9 Dec 2019
HIZENTRA(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) Receives Orphan-Drug Exclusivity for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 12 Nov 2019
ACR 2019: Lilly Presents 52-Week Head-to-Head (SPIRIT-H2H) Data from Taltz(R) (ixekizumab) Versus Humira(R) (adalimumab) Trial in Psoriatic Arthritis
Biopharmaceuticals

HSMN NewsFeed - 12 Nov 2019
ACR 2019: Lilly Presents Positive New Data from COAST-X, a Phase 3 Study of Taltz(R) (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis
Biopharmaceuticals

HSMN NewsFeed - 8 Nov 2019
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA(R) (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Nov 2019
EIP Pharma Announces Clinical Trial Results of REVERSE-SD, a Phase 2b Study of Neflamapimod in Early-stage Alzheimer's Disease
Biopharmaceuticals Neurology

HSMN NewsFeed - 5 Nov 2019
Regeneron Provides Updates on Phase 3 Libtayo(R) (cemiplimab) Development Program in Advanced Non-small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 Oct 2019
Biogen and Alkermes Announce FDA Approval of VUMERITY(TM) (diroximel fumarate) for Multiple Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 22 Oct 2019
Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI(R) Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Oct 2019
Nplate(R) (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Oct 2019
FDA Grants Ofev(R) Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Oct 2019
New Head-to-Head Data Show Taltz(R) (ixekizumab) Superiority versus TREMFYA(R) (guselkumab) in People with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology

HSMN NewsFeed - 2 Oct 2019
Upsher-Smith Laboratories Launches Tosymra(TM) (sumatriptan) Nasal Spray For The Acute Treatment Of Migraine In Adults
Biopharmaceuticals Neurology Drug Delivery Product Launch

HSMN NewsFeed - 24 Sep 2019
Emmaus Life Sciences Reinforces Positive Outcomes of Endari(R) Clinical Trials, Including Efficacy Findings That Led to FDA Approval
Biopharmaceuticals

HSMN NewsFeed - 20 Sep 2019
CHMP Issues Positive Opinion to Expand Trulicity(R) (dulaglutide) Label to Include Results from REWIND Cardiovascular Outcomes Trial
Biopharmaceuticals Endocrinology Cardiology Regulatory

HSMN NewsFeed - 11 Sep 2019
Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations
Biopharmaceuticals Oncology

HSMN NewsFeed - 10 Sep 2019
Pharvaris Announces $66 Million Series B Financing to Advance the Clinical Development of an Oral Therapy for Hereditary Angioedema
Biopharmaceuticals Venture Capital Personnel

HSMN NewsFeed - 26 Aug 2019
Lilly Receives U.S. FDA Approval for Taltz(R) (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Aug 2019
Amgen To Acquire Otezla(R) For $13.4 Billion In Cash, Or Approximately $11.2 Billion Net Of Anticipated Future Cash Tax Benefits
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 15 Aug 2019
Harmony Biosciences Announces FDA Approval of WAKIX(R) (Pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Aug 2019
Regeneron Announces Positive Topline Results from Phase 3 Trial of Evinacumab in Patients with Severe, Inherited Form of High Cholesterol
Biopharmaceuticals Cardiology

HSMN NewsFeed - 5 Aug 2019
AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Aug 2019
Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo(R) (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 Jul 2019
Lilly's Verzenio(R) (abemaciclib) Significantly Extended Life in Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2
Biopharmaceuticals Oncology

HSMN NewsFeed - 12 Jul 2019
AHS 2019: Post-Hoc Analyses of Phase 3 Pivotal Studies of Emgality(R) (galcanezumab-gnlm) Show Improvements in Daily Functioning and Reductions in Disability in Patients with Chronic and Episodic Migraine
Biopharmaceuticals Neurology

HSMN NewsFeed - 27 Jun 2019
DURECT Announces Submission to FDA of a Full Response to the POSIMIR(R) Complete Response Letter
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 26 Jun 2019
U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 14 Jun 2019
Lilly Presents Positive Results for Taltz(R) (ixekizumab) vs. Humira(R) (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis at the European Congress of Rheumatology
Biopharmaceuticals

HSMN NewsFeed - 11 Jun 2019
Lilly to Present 5-Year Sustained Efficacy and Safety Results for Taltz(R) (ixekizumab) in Patients with Plaque Psoriasis at the World Congress of Dermatology
Biopharmaceuticals Dermatology

HSMN NewsFeed - 4 Jun 2019
Braeburn Announces Publication of Phase 3 Study Results Showing Long-term Safety and Effectiveness of BRIXADI(TM) (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder
Biopharmaceuticals

HSMN NewsFeed - 28 May 2019
BioMarin Announces that Phase 3 Cohort of Valoctocogene Roxaparvovec, Gene Therapy Study in Severe Hemophilia A Met Pre-Specified Criteria for Regulatory Submissions in the U.S. and Europe
Biopharmaceuticals

HSMN NewsFeed - 17 May 2019
U.S. FDA Approves GATTEX(R) (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 8 May 2019
Daiichi Sankyo Announces [Fam-] Trastuzumab Deruxtecan Demonstrated Clinically Meaningful Response in Patients with Refractory HER2 Positive Metastatic Breast Cancer, a Population with High Unmet Need
Biopharmaceuticals Oncology

HSMN NewsFeed - 4 Apr 2019
Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Mar 2019
Novartis receives FDA approval for Mayzent(R) (siponimod), the first oral drug to treat secondary progressive MS with active disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 18 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Biopharmaceuticals FDA Regulatory

HSMN NewsFeed - 18 Mar 2019
Allergan Announces FDA Approval of AVYCAZ(R) (ceftazidime and avibactam) for Pediatric Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2019
Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Feb 2019
FDA Approves Taiho Oncology's LONSURF(R) (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 Feb 2019
U.S. FDA Approves DARZALEX(R) (daratumumab) Split-Dosing Regimen
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Jan 2019
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Jan 2019
European Commission Approves BLINCYTO(R) (blinatumomab) In Patients With Philadelphia Chromosome Negative Minimal Residual Disease-Positive B-cell Precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 18 Jan 2019
Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of LARTRUVO(R)
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Jan 2019
Slayback Pharma Announces FDA Approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml in a Multi-Dose Vial, the First Generic Equivalent of Makena(R) Injection 1,250 mg/ 5 ml Multi-Dose Vial
Biopharmaceuticals Generics FDA Product Launch

HSMN NewsFeed - 18 Dec 2018
Lilly Announces Publication of Analyses Showing Benefit of the Addition of Verzenio(R) (Abemaciclib) in Multiple Subgroups of Patients with Advanced Breast Cancer Identified as Having a More Concerning Prognosis
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Dec 2018
Lilly Announces Positive Top-Line Results for Taltz(R) (ixekizumab) vs. Humira(R) (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis
Biopharmaceuticals

HSMN NewsFeed - 13 Dec 2018
FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE)
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Nov 2018
Indivior Announces Health Canada Approval of SUBLOCADE(TM) (Buprenorphine Extended-Release) Injection for Patients with Moderate to Severe Opioid Use Disorder
Biopharmaceuticals Regulatory

HSMN NewsFeed - 19 Nov 2018
Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Avelumab in Platinum-Resistant/Refractory Ovarian Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 14 Nov 2018
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality(TM) (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 5 Nov 2018
EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 1 Nov 2018
AbbVie Receives European Commission Approval of VENCLYXTO(R) (venetoclax) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 30 Oct 2018
U.S. FDA Approves INVOKANA(R) (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
Biopharmaceuticals Endocrinology Cardiology FDA

HSMN NewsFeed - 17 Oct 2018
AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA(R) (ibrutinib) in Combination with Obinutuzumab (GAZYVA(R)) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Oct 2018
Rigel Receives EMA Validation of the Marketing Authorization Application for Fostamatinib Disodium Hexahydrate in Chronic Immune Thrombocytopenia (ITP) in Adult Patients
Biopharmaceuticals Regulatory

HSMN NewsFeed - 21 Sep 2018
Lilly Receives Positive CHMP Opinion for Emgality(TM) (galcanezumab) for the Prophylaxis of Migraine in Adults
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 13 Sep 2018
FDA Approves CroFab(R) Product Improvements
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Sep 2018
Lilly Announces Initiation of IXORA-R Head-to-Head Trial Comparing Taltz(R) and Tremfya(R) in Patients with Moderate-to-Severe Plaque Psoriasis
Biopharmaceuticals

HSMN NewsFeed - 29 Aug 2018
European Commission Approves BLINCYTO(R) (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 27 Aug 2018
AbbVie Announces IMBRUVICA(R) (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström's Macroglobulinemia, a Rare Type of Blood Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Aug 2018
Vyxeos(R) Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 Aug 2018
IDELVION(R) 3500 IU Vials Now Available to Provide Convenience to Patients
Biopharmaceuticals Product Launch

HSMN NewsFeed - 17 Aug 2018
Eisai And Merck Announce FDA Approval Of LENVIMA(R) (lenvatinib) Capsules For First-Line Treatment Of Unresectable Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Aug 2018
US Food and Drug Administration Approves ARAKODA(TM) (tafenoquine) tablets for oral use; First preventative antimalarial approved in almost two decades
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Aug 2018
Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX(R) (daratumumab) Split Dosing Regimen
Biopharmaceuticals Oncology FDA Regulatory

HSMN NewsFeed - 8 Aug 2018
United Therapeutics Announces FREEDOM-EV Study Of Orenitram Meets Primary Endpoint
Biopharmaceuticals

HSMN NewsFeed - 7 Aug 2018
Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI(TM) in combination with MEKTOVI(R) and cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Aug 2018
FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Jul 2018
AbbVie Receives U.S. FDA Approval of ORILISSA(TM) (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 20 Jul 2018
FDA Grants Approval of TIBSOVO(R), the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 13 Jul 2018
The National Comprehensive Cancer Network (NCCN) Guidelines Recommend BRAFTOVI(TM) (encorafenib) in Combination with MEKTOVI(R) (binimetinib) as a Category 1 Treatment Option for Patients with Advanced BRAF-mutant Melanoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Jul 2018
New England Journal of Medicine Publishes Results from Pivotal Study of TEGSEDI(TM) (inotersen) for the Treatment of Hereditary ATTR Amyloidosis
Biopharmaceuticals Neurology

HSMN NewsFeed - 2 Jul 2018
Phase III IMpassion130 Study Showed Genentech's TECENTRIQ Plus Abraxane Significantly Reduced the Risk of Disease Worsening or Death in People With Metastatic or Locally Advanced Triple Negative Breast Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 28 Jun 2018
Lilly Announces Positive Top-Line Results for Second Phase 3 Study of Taltz(R) (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) for TNF Inhibitor-Experienced Patients
Biopharmaceuticals

HSMN NewsFeed - 28 Jun 2018
Biohaven Expands Rimegepant Development Program to Include New Prevention of Migraine Phase 3 Trial and Highlights Key Late-Breaking Presentations at American Headache Society (AHS) Annual Scientific Meeting
Biopharmaceuticals

HSMN NewsFeed - 26 Jun 2018
Salix And US WorldMeds Enter Into Exclusive Co-Promotion Agreement For Opioid Withdrawal Treatment LUCEMYRA(TM) (lofexidine)
Biopharmaceuticals Distribution

HSMN NewsFeed - 25 Jun 2018
IMBRUVICA(R) (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Jun 2018
Impel NeuroPharma Announces FDA Clearance of IND for Pivotal Phase 3 Study of INP104 for Acute Treatment of Migraine
Biopharmaceuticals Drug Delivery Neurology FDA

HSMN NewsFeed - 15 Jun 2018
AbbVie Announces New Undetectable Minimal Residual Disease Data from Phase 3 Relapsed/Refractory Chronic Lymphocytic Leukemia MURANO Trial of Venetoclax in Combination with Rituximab at 23rd European Hematology Association Annual Congress
Biopharmaceuticals Oncology

HSMN NewsFeed - 6 Jun 2018
Partner Therapeutics (PTx) Announces US FDA Approval of Leukine(R) (sargramostim) for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Jun 2018
FDA Expands Lilly's ALIMTA(R) (pemetrexed) Label to Include Combination with KEYTRUDA(R) (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 May 2018
FDA expedites review of Novartis drug Promacta(R) for first-line severe aplastic anemia (SAA)
Biopharmaceuticals FDA

HSMN NewsFeed - 29 May 2018
ADAPT Pharma(R) Launches NARCANDirect.com
Biopharmaceuticals Product Launch

HSMN NewsFeed - 24 May 2018
IMBRUVICA(R) (ibrutinib) Plus GAZYVA(R) (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint
Biopharmaceuticals Oncology

HSMN NewsFeed - 21 May 2018
EmeTerm Anti-Nausea and Vomiting Wristband is FDA Cleared
Devices Neurology Product Launch

HSMN NewsFeed - 18 May 2018
FDA Approves Aimovig(TM) (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 7 May 2018
Amneal Initiates Phase 3 Study for IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa (CD-LD) in Advanced Parkinson's Disease Patients
Biopharmaceutical Neurology

HSMN NewsFeed - 24 Apr 2018
AAN 2018: Lilly's Galcanezumab Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed to Respond to Multiple Preventive Therapies
Biopharmaceuticals Neurology

HSMN NewsFeed - 23 Apr 2018
Theravance Biopharma Reports Positive New Data from Multiple Studies of VIBATIV(R) (telavancin) at 2018 ECCMID(TM) Conference
Biopharmaceuticals

HSMN NewsFeed - 20 Apr 2018
Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO(R) (fosnetupitant/ palonosetron) in the United States
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 20 Apr 2018
Women Treated with Hologic's NovaSure(R) Endometrial Ablation System in New Study Reported Higher Amenorrhea Rates than Those Treated with Minerva
Devices Interventional

HSMN NewsFeed - 2 Apr 2018
Duchesnay USA Announces Launch of Bonjesta(R) (doxylamine succinate - pyridoxine hydrochloride) in the United States
Biopharmaceuticals Product Launch

HSMN NewsFeed - 23 Mar 2018
Amgen Receives Positive CHMP Opinion Recognizing That Repatha(R) (evolocumab) Prevents Heart Attacks And Strokes
Biopharmaceuticals Cardiology Regulatory

HSMN NewsFeed - 21 Mar 2018
Boston Scientific Announces Agreement To Acquire NxThera
Devices Urology Mergers & Acquisitions

HSMN NewsFeed - 16 Mar 2018
FDA Approves Hizentra(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Mar 2018
U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 1 Mar 2018
SUBLOCADE(TM) (Buprenorphine Extended-Release) is Now Available as First and Only Monthly Injectable Buprenorphine in the U.S. to Treat Patients with Moderate to Severe Opioid Use Disorder
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 26 Feb 2018
New Data Show Lilly's Trulicity(R) (dulaglutide) in Combination with an SGLT-2 Inhibitor Improves Blood Sugar Control in People with Type 2 Diabetes
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 23 Feb 2018
Amgen Receives Positive Opinion Expanding Use Of XGEVA(R) (denosumab) To Cover Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma In Europe
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 19 Feb 2018
AAD 2018: Treatment with Lilly's Taltz(R) (ixekizumab) Resulted in Improvement in Impact of Genital Psoriasis on Sexual Activity
Biopharmaceuticals Dermatology

HSMN NewsFeed - 14 Feb 2018
Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema
Biopharmaceuticals Ophthalmology

HSMN NewsFeed - 13 Feb 2018
Lilly Announces Positive Top-Line Phase 3 Results for Taltz(R) (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
Biopharmaceuticals

HSMN NewsFeed - 12 Feb 2018
Ferring's CLENPIQ(TM) (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep Now Available
Biopharmaceuticals Gastroenterology Product Launch

HSMN NewsFeed - 8 Feb 2018
ZYTIGA(R) (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Feb 2018
FDA Approves AVYCAZ(R) (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Feb 2018
Partner Therapeutics (PTx) Acquires Leukine(R) from Sanofi
Biopharmaceuticals Oncology Acquisitions

HSMN NewsFeed - 29 Jan 2018
gammaCore(R) Receives FDA Clearance for the Acute Treatment of Pain Associated with Migraine Headache in Adult Patients
Devices Neurology FDA

HSMN NewsFeed - 19 Jan 2018
Independent Imaging Review Confirmed Positive Data from Primary Analysis of REFLECT Trial Evaluating Lenvatinib Compared to Sorafenib in Unresectable Hepatocellular Carcinoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Jan 2018
Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Jan 2018
Pharming Announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Jan 2018
Morphotek Announces FDA Acceptance Of Investigational New Drug Application For Next-Generation Farletuzumab Antibody-Drug Conjugate MORAb-202
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Jan 2018
BYDUREON(R) BCise(TM) Injectable Medicine Now Available In The US For Patients With Type-2 Diabetes
Biopharmaceuticals Endocrinology Product Launch

HSMN NewsFeed - 5 Jan 2018
FDA Approves XGEVA(R) (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Jan 2018
Neurogastrx, Inc. Raises $45M Series A To Bring Lead GI Candidate Through Proof Of Concept
Biopharmaceuticals Venture Capital Personnel

HSMN NewsFeed - 4 Jan 2018
Novartis drug Promacta(R) receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Jan 2018
Acacia Pharma Announces FDA Acceptance of NDA Filing For BAREMSIS(R) for the Management of Post-operative Nausea & Vomiting
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Jan 2018
Recro Pharma Announces Key Executive Promotions to the Financial Team
Biopharmaceuticals Personnel

HSMN NewsFeed - 22 Dec 2017
Novartis' combination therapy Tafinlar(R) + Mekinist(R) granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 15 Dec 2017
Egalet Receives FDA Tentative Approval for Expanded Label for ARYMO(R) ER (morphine sulfate) C-II, an Extended-Release Morphine Product Formulated with Abuse-Deterrent Properties for Treatment of Chronic Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Dec 2017
DARZALEX(R) (daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible
Biopharmaceuticals Oncology

HSMN NewsFeed - 11 Dec 2017
FDA Accepts Biologics License Application (BLA) to Review Galcanezumab for the Prevention of Migraine in Adults
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Dec 2017
INVOKANA(R) (canagliflozin) Significantly Improved Renal Outcomes and Demonstrated Potential Renal Protective Effects in Patients with Type 2 Diabetes Who Have or Are at Risk for Cardiovascular Disease
Biopharmaceuticals Nephrology

HSMN NewsFeed - 1 Dec 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Nov 2017
Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Nov 2017
U.S. FDA Approves Kaléo's AUVI-Q(R) (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 20 Nov 2017
United Therapeutics Announces Additional Six Months Of Regulatory Exclusivity For Adcirca(R)
Biopharmaceuticals FDA Licensing

HSMN NewsFeed - 16 Nov 2017
Biohaven Completes Enrollment In The First Of Two Pivotal Phase 3 Clinical Trials Of Rimegepant, A Second Generation Oral CGRP-Receptor Antagonist, For The Acute Treatment Of Migraine
Biopharmaceuticals Neurology

HSMN NewsFeed - 13 Nov 2017
EMD Serono Receives FDA Approval for New GONAL-f(R) RFF Redi-ject(R) Pen
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 8 Nov 2017
Long-Term Use of Lilly's Taltz(R) (ixekizumab) Shows Efficacy Improvements in Psoriatic Arthritis for Patients with Prior Inadequate Response or Intolerance to TNF Inhibitors
Biopharmaceuticals

HSMN NewsFeed - 23 Oct 2017
United Therapeutics Announces FDA Approval of Third Generation Nebulizer for the Tyvaso(R) Inhalation System
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 20 Oct 2017
Celgene Provides Update on GED-0301 (mongersen) Inflammatory Bowel Disease Program
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 12 Oct 2017
Ortho Dermatologics Announces Two-Year Findings From Pivotal Phase 3 Study Of SILIQ(TM) (brodalumab) Injection Data Demonstrating Long-Term Efficacy Profile
Biopharmaceuticals Dermatology

HSMN NewsFeed - 12 Oct 2017
FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio(TM) (abemaciclib) as Initial Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Oct 2017
Neurocrine Announces FDA Approval of 80 mg INGREZZA(R) (valbenazine) Capsules for the Treatment of Adults with Tardive Dyskinesia (TD)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 28 Sep 2017
AbbVie Announces Global Resolution of HUMIRA(R) (adalimumab) Patent Disputes with Amgen
Biopharmaceuticals Generics Litigation Licensing

HSMN NewsFeed - 21 Sep 2017
European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 15 Sep 2017
New indication for BRIVIACT(R) (brivaracetam): UCB's newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 14 Sep 2017
Pfizer and Astellas Announce Positive Top-Line Results from Phase 3 PROSPER Trial of XTANDI (enzalutamide) in Patients with Non-Metastatic Castration-Resistant Prostate Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 11 Sep 2017
electroCore Announces Results from gammaCore(R) (non-invasive vagus nerve stimulator) Study in Migraine at the 18th Congress of the International Headache Society
Devices Neurology

HSMN NewsFeed - 11 Sep 2017
Oncolytics Biotech(R) Announces the Presentation of REOLYSIN(R) Clinical Data at ESMO 2017 Congress
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Sep 2017
IHC 2017: Lilly's Galcanezumab Demonstrates Positive Long-Term Safety Results for up to 12 Months in Patients with Migraine
Biopharmaceutical Neurology

HSMN NewsFeed - 6 Sep 2017
AbbVie Submits New Drug Application to U.S. FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Sep 2017
FDA approves Mylotarg for treatment of acute myeloid leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Aug 2017
Daiichi Sankyo Terminates Development and Commercialization Agreement with Charleston Laboratories Regarding Hydrocodone Products in the U.S., including CL-108
Biopharmaceuticals

HSMN NewsFeed - 7 Aug 2017
Impax Announces Settlement of Contract Litigation on Opana(R) ER (Oxymorphone Hydrochloride) CII Extended-Release Tablets
Biopharmaceuticals Litigation

HSMN NewsFeed - 4 Aug 2017
Lilly Announces Positive Results for Second Phase 3 Study of Lasmiditan for the Acute Treatment of Migraine
Biopharmaceuticals Neurology

HSMN NewsFeed - 1 Aug 2017
AcelRx Pharmaceuticals Reports Successful Outcome of ZALVISO Phase 3 IAP312 Study on Device Functionality
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 31 Jul 2017
Biohaven Initiates Second Pivotal Phase 3 Clinical Trial of Oral CGRP Antagonist for the Acute Treatment of Migraine
Biopharmaceuticals Neurology

HSMN NewsFeed - 27 Jul 2017
U.S. FDA Grants Priority Review for an Epinephrine Auto-Injector in Development by Kaléo Specifically for Infants and Small Children
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 25 Jul 2017
HAEGARDA(R) (C1 Esterase Inhibitor Subcutaneous [Human]) Now Available in the United States for Patients with Hereditary Angioedema
Biopharmaceuticals Product Launch

HSMN NewsFeed - 25 Jul 2017
EnteroMedics Announces First Veterans Choice Program vBloc(R) Implant for Obesity at Methodist Dallas Medical Center
Devices

HSMN NewsFeed - 24 Jul 2017
eFFECTOR Therapeutics Completes $38.6 Million Series C Financing
Biopharmaceuticals Oncology Venture Capital Personnel

HSMN NewsFeed - 21 Jul 2017
CSL Behring Receives Orphan-Drug Exclusivity for HAEGARDA(R) (C1 Esterase Inhibitor Subcutaneous [Human])
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Jul 2017
EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 21 Jul 2017
Lexicon Collaborator Ipsen Receives Positive CHMP Opinion For Xermelo(R) (Telotristat Ethyl)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 23 Jun 2017
Lundbeck and Takeda receive Complete Response Letter from the FDA for Trintellix(R) (vortioxetine) sNDA
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Jun 2017
EnteroMedics Announces vBloc Therapy to be Presented by Keynote Speaker at Major International Obesity Conference
Devices

HSMN NewsFeed - 19 Jun 2017
FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA(R) (denosumab) To Include Multiple Myeloma Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jun 2017
NCCN Guidelines For Neuroendocrine Tumors Include XERMELO In Combination With Somatostatin Analog Therapy As A Recommended Treatment Option For Patients With Carcinoid Syndrome Diarrhea
Biopharmaceuticals Oncology

HSMN NewsFeed - 16 Jun 2017
EULAR 2017: Lilly's Taltz(R) (ixekizumab) Demonstrated No Progression or Minimal Progression of Radiographic Disease in Patients with Psoriatic Arthritis Through 52 Weeks
Biopharmaceuticals

HSMN NewsFeed - 16 Jun 2017
New Safety and Long-Term Efficacy Data from Baricitinib Clinical Trials in Patients with Moderate-to-Severe Rheumatoid Arthritis Presented at EULAR 2017
Biopharmaceuticals

HSMN NewsFeed - 5 Jun 2017
New Data Presented at ASCO 2017 Finds IMBRUVICA(R) (ibrutinib) May Offer a More Targeted Approach to Chronic Lymphocytic Leukemia (CLL) Treatment than Chemotherapy Agent Chlorambucil in Treatment-Naïve Patients
Biopharmaceuticals Oncology

HSMN NewsFeed - 31 May 2017
EnteroMedics Announces First vBloc(R) Neurometabolic Therapy Implant at AMITA Health Adventist Medical Center Bolingbrook
Devices Neurology

HSMN NewsFeed - 30 May 2017
Array BioPharma and Bristol-Myers Squibb Announce Strategic Collaboration
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 May 2017
Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS(R) (raltegravir) 600 mg in the European Union
Biopharmaceuticals Regulatory

HSMN NewsFeed - 18 May 2017
Amgen Submits Biologics License Application To The FDA For Erenumab
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 18 May 2017
EnteroMedics Announces First vBloc(R) Neurometabolic Therapy Implant at McGuire Veterans Affairs Medical Center
Devices Neurology

HSMN NewsFeed - 12 May 2017
Lilly Announces Positive Results for Three Phase 3 Studies of Galcanezumab for the Prevention of Episodic and Chronic Migraine
Biopharmaceuticals Neurology

HSMN NewsFeed - 12 May 2017
Ardelyx Reports Successful Phase 3 T3MPO-1 Trial of Tenapanor in Patients with IBS-C
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 9 May 2017
FDA Grants BAVENCIO(R) (avelumab) Approval for a Common Type of Advanced Bladder Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 May 2017
Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Results from Long-term Phase 3 Safety Study of CAM2038
Biopharmaceuticals

HSMN NewsFeed - 2 May 2017
Orexigen Therapeutics Announces Commercialization and Distributorship Arrangement with Navamedic ASA for Mysimba(R) (naltrexone HCl / bupropion HCl prolonged release) in Five Nordic Countries
Biopharmaceuticals Distribution

HSMN NewsFeed - 28 Apr 2017
Novartis Receives FDA Approval for Rydapt(R) in Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) and Three Types of Systemic Mastocytosis (SM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Apr 2017
FDA Approves Radius Health’s TYMLOS(TM) (abaloparatide), a Bone Building Agent for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Apr 2017
FDA Approves XATMEP(TM), the First and Only Ready-To-Use Methotrexate Oral Solution
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Apr 2017
Inspirion Delivery Sciences Receives FDA Approval for RoxyBond(TM) (oxycodone hydrochloride) tablets CII, the First and Only Immediate Release Opioid Analgesic with Abuse-Deterrent Label Claims
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 24 Apr 2017
Lilly Announces Phase 3 MONARCH 3 Breast Cancer Study of Abemaciclib Demonstrated Superior Progression-Free Survival at Interim Analysis
Biopharmaceuticals Oncology

HSMN NewsFeed - 24 Apr 2017
SIR-Spheres(R) Y-90 Resin Microspheres Substantially Improves Quality of Survival in Primary Liver Cancer, New Study Against Standard Treatment Shows
Devices Oncology

HSMN NewsFeed - 21 Apr 2017
Neurocrine Announces INGREZZA(TM) Long-Term Safety and Efficacy Data to be Presented at the 2017 American Academy of Neurology Annual Meeting
Biopharmaceuticals Neurology

HSMN NewsFeed - 21 Apr 2017
Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR(12) Rates in Challenging to Treat Genotype 3 Chronic Hepatitis C
Biopharmaceuticals

HSMN NewsFeed - 20 Apr 2017
FDA Clears Halyard Health's COOLIEF for the Management of Osteoarthritis Knee Pain
Devices Orthopaedic FDA

HSMN NewsFeed - 17 Apr 2017
AMAG Submits Supplemental New Drug Application to FDA for Makena(R) (Hydroxyprogesterone Caproate Injection) Auto-Injector for Subcutaneous Use
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 13 Apr 2017
RedHill Biopharma and IntelGenx Announce Marketing Approval of RIZAPORT(R) for Migraines in Luxembourg
Biopharmaceuticals Drug Delivery Regulatory

HSMN NewsFeed - 7 Apr 2017
Medtronic Announces Voluntary Worldwide Recall of its StrataMR(TM) Adjustable Valves and Shunts
Devices Neurosurgery Product Recall

HSMN NewsFeed - 30 Mar 2017
U.S. FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's HUMIRA(R) (adalimumab) Prescribing Information
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Mar 2017
FDA Approves Genentech’s OCREVUS(TM) (Ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 24 Mar 2017
FDA Grants Approval for BAVENCIO(R) (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA Product Launch

HSMN NewsFeed - 23 Mar 2017
New England Journal of Medicine Publishes Pivotal Phase III Data for CSL Behring's Subcutaneous C1-Esterase Inhibitor in HAE Patients
Biopharmaceuticals

HSMN NewsFeed - 20 Mar 2017
Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study of Abemaciclib Met Primary Endpoint of Progression-Free Survival
Biopharmaceuticals Oncology

HSMN NewsFeed - 16 Mar 2017
Shire Receives European Approval for Label Extension of CINRYZE(R) (C1 inhibitor ) to Prevent and Treat Hereditary Angioedema (HAE) Attacks in Paediatric Patients with HAE
Biopharmaceuticals Regulatory

HSMN NewsFeed - 14 Mar 2017
Pfizer Launches Zavicefta(TM) (ceftazidime-avibactam) in the U.K. and Germany, a New Antibiotic to Treat Complicated Infections Caused by Gram-Negative Bacteria
Biopharmaceuticals Product Launch

HSMN NewsFeed - 2 Mar 2017
BLINCYTO(R) (blinatumomab) Significantly Improved Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia Compared To Chemotherapy
Biopharmaceuticals Oncology

HSMN NewsFeed - 22 Feb 2017
Repatha(R) (Evolocumab) Receives European Commission Approval For New 420 mg Single-Dose Delivery Option
Biopharmaceuticals Cardiology Regulatory

HSMN NewsFeed - 17 Feb 2017
LYNPARZA(TM) (olaparib) Meets Primary Endpoint in Phase III Trial in BRCA-Mutated Metastatic Breast Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Feb 2017
FDA Approves Amgen's Parsabiv(TM) (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 20 Jan 2017
Bristol-Myers Squibb Provides Regulatory Update in First-line Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jan 2017
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Jan 2017
Allergan and Gedeon Richter Announce Positive Phase III Results for Ulipristal Acetate 5 and 10 mg in the Treatment of Uterine Fibroids
Biopharmaceuticals

HSMN NewsFeed - 16 Jan 2017
European Commission Amends Marketing Authorisation for RUCONEST(R) to Include Self-Administration
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 Jan 2017
Study Results Published in the Journal of the American Medical Association Show Amgen's Parsabiv(TM) (Etelcalcetide) Significantly Reduced Serum Parathyroid Hormone in Adults With Secondary Hyperparathyroidism on Hemodialysis
Biopharmaceuticals

HSMN NewsFeed - 5 Jan 2017
Eisai Acquires All Global Development And Marketing Rights For Chronic Weight Management Treatment Lorcaserin HCI
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 27 Dec 2016
Shire Announces FDA Approval of Adynovate(R) for use in Children and Surgical Settings
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Dec 2016
AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Dec 2016
Janssen Submits Application Seeking FDA Approval of STELARA(R) (Ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 8 Dec 2016
Pharming Announces Completion of Acquisition of All North American Commercialisation Rights for RUCONEST(R) From Valeant
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 7 Dec 2016
Sobi and Horizon Pharma Enter Five-Year Distribution Agreement for Ravicti(R) and Ammonaps(R) Outside the United States
Biopharmaceuticals Distribution

HSMN NewsFeed - 5 Dec 2016
Novelion Therapeutics Subsidiary, Aegerion Pharmaceuticals, Enters Into Licensing Agreement With Amryt Pharma for LOJUXTA(R) (lomitapide)
Biopharmaceuticals Cardiology Licensing

HSMN NewsFeed - 28 Nov 2016
Conditional Approval from the European Commission to Treat Multiple Myeloma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 Nov 2016
Allergan Acquires Chase Pharmaceuticals to Expand CNS R&D Pipeline and Build on Commitment to Alzheimer's Disease
Biopharmaceuticals Neurology Mergers & Acquisitions

HSMN NewsFeed - 22 Nov 2016
DARZALEX(R) (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Nov 2016
Boston Biomedical Announces Orphan Drug Designation for Napabucasin in Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Nov 2016
CHMP Adopts Positive Opinion to Include Self-administration for RUCONEST(R)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 Nov 2016
Bristol-Myers Squibb’s Opdivo(R) (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Nov 2016
Allergan Announces Launch of TAYTULLA(TM) (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules) 1 mg/20 mcg, the First and Only Oral Contraceptive Softgel Capsule
Biopharmaceuticals Product Launch

HSMN NewsFeed - 10 Nov 2016
IBRANCE(R) (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 8 Nov 2016
Orexigen Therapeutics Announces Commercialization and Distributorship Agreement with Valeant for Contrave(R) (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand
Biopharmaceuticals Distribution

HSMN NewsFeed - 28 Oct 2016
Astellas to Acquire Ganymed Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 24 Oct 2016
Efficacy of Ofev(R) (nintedanib) Reinforced in Range of Patients with IPF in New Analyses Presented at CHEST
Biopharmaceuticals

HSMN NewsFeed - 18 Oct 2016
Shire Granted EU Marketing Authorization of Onivyde(R), in Combination With 5-Fluorouracil (5-FU) and Leucovorin (LV),for the Treatment of Metastatic Adenocarcinoma of the Pancreas in Adult Patients Who Have Progressed Following Gemcitabine-Based Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 14 Oct 2016
Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) for the Treatment of Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma After Autologous Stem Cell Transplant and Treatment With Brentuximab Vedotin
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 12 Oct 2016
AMAG Pharmaceuticals Announces Achievement of Key Milestones in Next Generation Development Programs for Makena(R) and Feraheme(R)
Biopharmaceuticals

HSMN NewsFeed - 11 Oct 2016
FDA Grants Priority Review to Genentech’s Lucentis(R) (Ranibizumab Injection) Supplemental Biologics License Application for Myopic Choroidal Neovascularization
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 10 Oct 2016
First Positive Phase 3 Results in Adjuvant Setting for Renal Cell Carcinoma Show SUTENT(R) (sunitinib) Extended Disease Free Survival After Surgical Removal
Biopharmaceuticals Oncology

HSMN NewsFeed - 6 Oct 2016
U.S. FDA Approves Orexo's Low Dose ZUBSOLV(R) Buprenorphine and Naloxone Sublingual Tablets (CIII)
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Sep 2016
EnteroMedics Announces Appointment of Dan Gladney as Chairman of the Board of Directors
Devices Neurology Gastroenterology Personnel

HSMN NewsFeed - 26 Sep 2016
AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA(R)) for Treatment of Marginal Zone Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Sep 2016
AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX(R) (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA(R) (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C
Biopharmaceuticals

HSMN NewsFeed - 21 Sep 2016
U.S. FDA Approves INVOKAMET(R) XR (Canagliflozin / Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 14 Sep 2016
European Commission Approves CABOMETYX(TM) (cabozantinib) Tablets for the Treatment of Advanced Renal Cell Carcinoma Following VEGF-Targeted Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 13 Sep 2016
vBloc Institute Demonstrates Positive Clinical Success in Patients Struggling with Weight Loss as Compared to Pivotal FDA Trial with EnteroMedics vBloc(R) Therapy in Combination with vBloc(R) Achieve Program
Devices Neurology

HSMN NewsFeed - 5 Sep 2016
Eisai Bewildered as German Institute for Quality and Efficiency in Health Care (IQWIG) Fails to Recognise Additional Benefit of Halaven(R) (eribulin) in the Treatment of Advanced Liposarcoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 31 Aug 2016
Allergan and Adamas Announce Settlement with Amneal Related to NAMZARIC(R) Patent Litigation
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 31 Aug 2016
XALKORI(R) (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 29 Aug 2016
New Repatha(R) (evolocumab) Analyses Show Efficacy and Safety Across Risk Groups in Results Presented at ESC Congress 2016
Biopharmaceuticals Cardiology

HSMN NewsFeed - 25 Aug 2016
Mylan Taking Immediate Action to Further Enhance Access to EpiPen(R) (Epinephrine Injection, USP) Auto-Injector
Biopharmaceuticals Devices Drug Delivery Reimbursement

HSMN NewsFeed - 12 Aug 2016
Acacia Pharma Announces Positive Results From a Pivotal Phase 3 Trial of BAREMSIS(TM) for the Treatment of Post-Operative Nausea & Vomiting
Biopharmaceuticals

HSMN NewsFeed - 10 Aug 2016
Heron Therapeutics Announces U.S. FDA Approval of SUSTOL(R) (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Aug 2016
Teva Announces Launch of Generic Gleevec(R) Tablets in the United States
Biopharmaceuticals Generics Oncology Product Launch

HSMN NewsFeed - 1 Aug 2016
Orexigen Completes Acquisition of All U.S. Rights to Contrave(R) and Launches U.S. Sales Organization
Biopharmaceuticals Acquisitions Product Launch

HSMN NewsFeed - 1 Aug 2016
Shire Announces FDA Approval of adynovate with BAXJECT III Reconstitution System
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Jul 2016
AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR(TM) (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Jul 2016
CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX(R) (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 7 Jul 2016
Shire Receives Extension of Market Authorization in Europe for Revestive(R) (Teduglutide) for the Treatment of Paediatric Patients with Short Bowel Syndrome (SBS)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 5 Jul 2016
Insys Therapeutics Announces FDA Approval of Syndros(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Jul 2016
European Commission Approves Extended Indication For Amgen's Kyprolis(R) (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma Patients
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 30 Jun 2016
OPKO Health to Acquire Transition Therapeutics
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 29 Jun 2016
AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA(R)) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options
Biopharmaceuticals

HSMN NewsFeed - 29 Jun 2016
EnteroMedics Highlights Recent Patient Success with vBloc(R) Therapy in Combination with vBloc(R) Achieve Program
Devices

HSMN NewsFeed - 29 Jun 2016
FDA Advisory Committee recommends approval of Jardiance(R) (empagliflozin) for cardiovascular indication in 12-11 vote
Biopharmaceuticals Endocrinology Cardiology FDA

HSMN NewsFeed - 23 Jun 2016
Allergan Announces FDA Approval of Supplemental New Drug Application (sNDA) for AVYCAZ(R) (ceftazidime and avibactam)
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Jun 2016
Orexigen Therapeutics Reports Favorable Markman Ruling in Contrave(R) Patent Litigation
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 1 Jun 2016
EnteroMedics Announces First-of-its-Kind Procedure with vBloc(R) Therapy Used as Adjunctive Rescue Treatment for Failed Gastric Sleeve in Patients with Obesity
Devices

HSMN NewsFeed - 31 May 2016
Allergan Receives FDA Approval of TEFLARO(R) (ceftaroline fosamil) for Pediatric Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 23 May 2016
Egalet Settles Patent Litigations with Purdue Pharma
Biopharmaceuticals Litigation

HSMN NewsFeed - 16 May 2016
Neos Therapeutics Announces U.S. Launch of Adzenys XR-ODT(TM) (Amphetamine Extended-Release Orally Disintegrating Tablet) for the Treatment of ADHD in Patients Six Years and Older
Biopharmaceuticals Product Launch

HSMN NewsFeed - 9 May 2016
Theravance Biopharma Announces FDA Approval of Expanded Label for VIBATIV(R) (telavancin)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 May 2016
U.S. FDA Expands IMBRUVICA(R) (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 May 2016
EnteroMedics Announces Closing of $6.25 Million Third Tranche of Previously-Announced Convertible Notes Offering
Devices Venture Capital

HSMN NewsFeed - 2 May 2016
EnteroMedics Announces Exclusive Federal Government Business Channel Sales Agreement with Academy Medical to Provide vBloc(R) Neurometabolic Therapy to US Department of Veterans Affairs Medical Facilities
Devices Distribution

HSMN NewsFeed - 27 Apr 2016
Novartis Receives Three FDA Breakthrough Therapy Designations for IlaristTo Treat Rare Types of Periodic Fever Syndromes
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Apr 2016
AbbVie's Investigational, Pan-Genotypic Regimen of ABT-493 and ABT-530 Shows High SVR Rates in Genotype 1 Hepatitis C Patients Who Failed Previous Therapy with Direct-Acting Antivirals
Biopharmaceuticals

HSMN NewsFeed - 15 Apr 2016
AbbVie Announces Real-World Data with VIEKIRAX(R) (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA(R) (dasabuvir tablets) from Large German Hepatitis C-Registry
Biopharmaceuticals

HSMN NewsFeed - 11 Apr 2016
Adapt Pharma Names Mike Kelly President of U.S. Operations
Biopharmaceuticals Personnel

HSMN NewsFeed - 7 Apr 2016
Pharming Announces Adoption by the European Commission of the CHMP Recommendation to Change the Terms of the Marketing Authorisation for Ruconest(R)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 18 Mar 2016
STELARA(R) Induced Clinical Response And Remission In Phase 3 Study For The Treatment Of Patients With Moderate To Severe Crohn's Disease Who Had Previously Failed Or Were Intolerant To Anti-TNF-Alpha Therapy
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 15 Mar 2016
CoLucid Pharmaceuticals Announces Election of Alison Lawton to Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 15 Mar 2016
Orexigen and Takeda Jointly Announce Orexigen's Acquisition of All Rights to CONTRAVE(R) in the United States
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 3 Mar 2016
Allergan Launches Bold Access To LILETTA(R) (levonorgestrel-releasing intrauterine system)
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 29 Feb 2016
CHMP Issues Positive Opinion for LONSURF(R) (trifluridine/tipiracil) for Refractory Metastatic Colorectal Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 26 Feb 2016
Galderma Delivers Innovation In Dermal Fillers With The Launch Of Two First-In-Class FDA Pivotal Phase III Trials
Biopharmaceuticals Dermatology

HSMN NewsFeed - 24 Feb 2016
FDA Accepts and Grants Priority Review for AVYCAZ(R) (ceftazidime and avibactam) Supplemental New Drug Application (sNDA)
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Feb 2016
Endo Announces Launch Of BELBUCA(TM) (Buprenorphine) Buccal Film For Chronic Pain Management
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 17 Feb 2016
Impax Receives FDA Approval for Generic Version of Adderall XR(R) (mixed salts of a single-entity amphetamine product) Capsules, CII
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 16 Feb 2016
VIVLODEX(TM) Now Available in U.S. Pharmacies for the Management of Osteoarthritis Pain
Biopharmaceuticals Product Launch

HSMN NewsFeed - 16 Feb 2016
FDA Accepts Supplemental New Drug Application (sNDA) for TEFLARO(R) (ceftaroline fosamil)
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Feb 2016
Phase 3 Study of BLINCYTO(R) (Blinatumomab) Met Primary Endpoint Of Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 1 Feb 2016
Mallinckrodt Completes Acquisition Of Three Commercial-Stage, Global Specialty Hemostasis Brands From The Medicines Company
Devices Surgery Acquisitions

HSMN NewsFeed - 29 Jan 2016
FDA Approves Eisai's Halaven(R) (eribulin mesylate) Injection for the Treatment of Patients with Advanced Liposarcoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Jan 2016
Merck Receives FDA Approval of ZEPATIER(TM) (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 28 Jan 2016
Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT(TM) (Amphetamine Extended-Release Orally Disintegrating Tablet) for the Treatment of ADHD in Patients 6 Years and Older
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 25 Jan 2016
Boston Biomedical's Investigational Cancer Stem Cell Pathway Inhibitor, Napabucasin (BBI608), Featured at the ASCO 2016 Gastrointestinal Cancers Symposium
Biopharmaceuticals Oncology Gastroenterology

HSMN NewsFeed - 21 Jan 2016
Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE(R) (dalbavancin)
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Jan 2016
VIBERZI(TM) (eluxadoline) Phase III Trial Results Published in The New England Journal of Medicine
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 20 Jan 2016
Orphan Medicine Designation and European Medicines Agency Public Opinion Summary Published by EMA Regarding Alferon N Injection(R) as a Treatment of Middle East Respiratory Syndrome (MERS)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 19 Jan 2016
Acorda to Acquire Biotie Therapies
Biopharmaceuticals Neurology Mergers & Acquisitions

HSMN NewsFeed - 15 Jan 2016
Impax Receives Approval of EMVERM(TM) (mebendazole) Chewable Tablets, 100 mg
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Jan 2016
EnteroMedics Announces Closing of $11 Million Tranche from Previously-Announced Convertible Notes Offering
Devices Neurology Venture Capital

HSMN NewsFeed - 8 Jan 2016
AcelRx Completes Protocol Review with FDA and Plans to Initiate Phase 3 Open-Label Study (IAP312) for Zalviso(TM) in 1Q 2016
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Jan 2016
AbbVie's HUMIRA(R) (Adalimumab) Receives First and Only Health Canada Approval for Moderate to Severe Hidradenitis Suppurativa
Biopharmaceuticals Regulatory

HSMN NewsFeed - 21 Dec 2015
Oral REVLIMID(R) Plus Dexamethasone Granted Approval for Treatment of Patients with Newly Diagnosed Multiple Myeloma in Japan
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 18 Dec 2015
European Commission Approves Amgen's IMLYGIC(TM) (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 14 Dec 2015
Antares Pharma Announces FDA Approval of Sumatriptan Injection USP
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Dec 2015
Allergan Announces U.S. Availability of VIBERZI(TM) (eluxadoline) for Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults
Biopharmaceuticals Gastroenterology Product Launch

HSMN NewsFeed - 10 Dec 2015
Lilly and Merck Expand Immuno-Oncology Collaboration Adding Abemaciclib and KEYTRUDA(R) Combination Trial
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Dec 2015
Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of BENDEKA(TM) (bendamustine hydrochloride) Injection
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Nov 2015
Pfizer Receives European Approval to Expand Use of XALKORI(R) (crizotinib) to First-Line Treatment of Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Nov 2015
European Commission Approves Reconciliation of Indications for nivolumab Under the Opdivo(R) European Marketing Authorization Application
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Nov 2015
European Commission Approves Amgen's BLINCYTO(R) (blinatumomab) for the Treatment of Adults with Philadelphia Chromosome-Negative Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 18 Nov 2015
Pfizer Reports Positive Topline Results from Phase 3 Trial Comparing XALKORI(R) (crizotinib) to Chemotherapy in Previously Untreated East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Biopharmaceuticals Oncology

HSMN NewsFeed - 13 Nov 2015
AbbVie Submits IMBRUVICA(R) (ibrutinib) Phase III Combination Data to U.S. FDA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Nov 2015
RedHill Biopharma and IntelGenx Announce First European Marketing Approval of RIZAPORT(TM) (RHB-103) for Migraines
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 2 Nov 2015
EnteroMedics Announces Dan Gladney Appointed President and Chief Executive Officer
Devices Gastroenterology Personnel

HSMN NewsFeed - 30 Oct 2015
Celgene’s VIDAZA(R) (Azacitidine for Injection) Approved by the European Commission as New Treatment for Elderly Patients with Acute Myeloid Leukaemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 27 Oct 2015
CoLucid Pharmaceuticals Announces Election of Mark Corrigan, M.D., to Board of Directors
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 26 Oct 2015
Macy Catheter(TM) Tray for Rapid Administration of Medications and Fluids Launched at ACEP
Devices Drug Delivery Product Launch

HSMN NewsFeed - 26 Oct 2015
U.S. FDA Approves BELBUCA(TM) (buprenorphine) Buccal Film for Chronic Pain Management
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 23 Oct 2015
Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX(TM) - First Low Dose SoluMatrix(R) Meloxicam for Osteoarthritis Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Oct 2015
Merrimack Announces U.S. FDA Approval of ONIVYDE(TM) (irinotecan liposome injection) for the Treatment of Patients with Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 Oct 2015
Heron Therapeutics Appoints Neil J. Clendeninn, M.D., Ph.D. as Senior Vice President and Chief Medical Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 1 Oct 2015
Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Oct 2015
BioMarin to Acquire Rights to Phenylketonuria (PKU) Franchise From Merck Serono
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 28 Sep 2015
AbbVie's VIEKIRAX(R) (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval in Japan for the Treatment of Genotype 1 Chronic Hepatitis C
Biopharmaceuticals Regulatory

HSMN NewsFeed - 25 Sep 2015
Celgene’s VIDAZA(R) (Azacitidine for Injection) Receives Positive CHMP Opinion as New Treatment for Elderly Patients with Acute Myeloid Leukaemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 11 Sep 2015
AbbVie's HUMIRA(R) (Adalimumab) Receives First and Only U.S. Food and Drug Administration Approval for Moderate to Severe Hidradenitis Suppurativa
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 20 Aug 2015
Valeant Pharmaceuticals To Acquire Sprout Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 20 Aug 2015
S1 Biopharma Supports FDA Approval of First-Ever Treatment for Hypoactive Sexual Desire Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Aug 2015
Baxter and Water Street Announce FDA Approval of CEFAZOLIN 2 Gram Premix
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Aug 2015
BioDelivery Sciences Announces FDA Approval of New Formulation of ONSOLIS(R) (fentanyl buccal soluble film) CII
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 29 Jul 2015
Galena Biopharma Launches Zuplenz(R) (ondansetron) Oral Soluble Film
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 27 Jul 2015
Lenox Hill Hospital Using New Device to Treat Aneurysms
Devices Interventional

HSMN NewsFeed - 24 Jul 2015
FDA approves Novartis drug Odomzo(R) (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Jul 2015
Allergan Enters Into Licensing Agreement with Merck to Obtain Exclusive Worldwide Rights to CGRP Migraine Development Program
Biopharmaceuticals Acquisitions Licensing

HSMN NewsFeed - 2 Jul 2015
Zalviso(TM) Phase 3 Orthopedic Results Published In Anesthesiology Demonstrate Significant Reductions In Post-Operative Pain
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 12 Jun 2015
FDA Approves Promacta(R) for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication
Biopharmaceuticals FDA

HSMN NewsFeed - 29 May 2015
Amgen Presents Pooled Phase 3 AMG 416 Data For The Treatment Of Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease
Biopharmaceuticals

HSMN NewsFeed - 27 May 2015
The European Commission Approves ALOXI(R) (palonosetron HCl) Injection to Prevent Nausea and Vomiting Due to Chemotherapy in Children as Young as One Month
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 20 May 2015
EnteroMedics Announces First US Commercial Implant of vBloc(R) Neurometabolic Therapy System at Tufts Medical Center in Boston, Massachusetts
Devices

HSMN NewsFeed - 18 May 2015
Actavis Launches NAMZARIC(TM) (memantine hydrochloride extended-release and donepezil hydrochloride), a Fixed-Dose Combination Therapy for the Treatment of Moderate to Severe Alzheimer's Disease
Biopharmaceuticals Neurology Product Launch

HSMN NewsFeed - 6 May 2015
EMD Serono Initiates Co-Promotion of XALKORI(R) (crizotinib) with Pfizer in the United States
Biopharmaceuticals Oncology Distribution

HSMN NewsFeed - 24 Apr 2015
Bristol-Myers Squibb Receives Positive CHMP Opinion in the European Union for Opdivo (nivolumab) for the Treatment of Advanced Melanoma in Both First-Line and Previously Treated Patients
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 13 Apr 2015
Actavis and Medicines360 Announce U.S. Availability of LILETTA(TM) (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Three Years
Biopharmaceuticals Product Launch

HSMN NewsFeed - 6 Apr 2015
European Commission Approves Amgen's Vectibix(R) (panitumumab) As First-Line Treatment In Combination With FOLFIRI Chemotherapy For Metastatic Colorectal Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 30 Mar 2015
The Medicines Company Receives European Commission Approval for Three Hospital Acute Care Products: KENGREXAL(TM) (cangrelor), ORBACTIV(R) (oritavancin) and RAPLIXA(TM) (sealant powder)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 19 Mar 2015
Daiichi Sankyo Signs Agreement With AstraZeneca To Co-Commercialize MOVANTIK In The US
Biopharmaceuticals

HSMN NewsFeed - 17 Mar 2015
Jakavi(R) (ruxolitinib) Receives European Commission Approval as First Targeted Therapy for Patients with Polycythemia Vera
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 13 Mar 2015
Actavis Receives FDA Approval of SAPHRIS(R) for Pediatric Patients (age 10-17) for Acute Treatment of Manic or Mixed Episodes of Bipolar I Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2015
Mylan Launches Generic Antabuse(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 25 Feb 2015
Topline Results of Phase 3 Trial Show Eribulin Mesylate Injection Meets Primary Endpoint of Overall Survival in Advanced Soft Tissue Sarcoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 23 Feb 2015
Eiger BioPharmaceuticals Announces Presentation of Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib
Biopharmaceuticals

HSMN NewsFeed - 19 Feb 2015
FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf (Vemurafenib) in Advanced Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Feb 2015
Genentech’s Phase III Study of Gazyva(R) Showed Significant Benefit in Refractory Indolent Non-Hodgkin’s Lymphoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Feb 2015
FDA Approves New Dosing Option for CSL Behring's Hizentra(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Jan 2015
The Medicines Company Receives CHMP Positive Opinions for Three Hospital Acute Care Products: KENGREXAL(TM) (cangrelor), ORBACTIV(TM) (oritavancin) and RAPLIXA(TM) (sealant powder)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 16 Jan 2015
European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX(R) (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA(R) (dasabuvir tablets) for the Treatment of Chronic Hepatitis C
Biopharmaceuticals Regulatory

HSMN NewsFeed - 18 Dec 2014
The Medicines Company and SciClone Pharmaceuticals Establish Strategic Partnership for Two Cardiovascular Products in China
Biopharmaceuticals Cardiology Licensing

HSMN NewsFeed - 8 Dec 2014
CardioKinetix Completes $50 Million Financing and Signs Agreement With Edwards Lifesciences, Including Exclusive Option to Purchase
Devices Interventional Cardiology Venture Capital

HSMN NewsFeed - 1 Dec 2014
Cepheid Receives FDA Clearance for Xpert Norovirus, the First On-Demand Molecular Test for Detection of Norovirus
Diagnostics FDA

HSMN NewsFeed - 3 Nov 2014
Salix and Pharming Announce the Launch of RUCONEST(R) in the U.S. for the Treatment of Acute Angioedema Attacks in Patients with Hereditary Angioedema (HAE)
Biopharmaceuticals Product Launch

HSMN NewsFeed - 30 Oct 2014
U.S. FDA Approves Once-Daily XIGDUO(TM) XR Tablets for Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 16 Oct 2014
FDA Approves Boehringer Ingelheim's OFEV(R) (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Oct 2014
FDA Approves AKYNZEO(R) (netupitant/palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Sep 2014
AMAG Pharmaceuticals to Acquire Lumara Health Maternal Health Business
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 27 Aug 2014
Ligand Partner GlaxoSmithKline Receives U.S. FDA Approval for Promacta(R)/Revolade(TM) For Use in Patients with Severe Aplastic Anemia
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Aug 2014
European Commission Approves Bristol-Myers Squibb’s Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection
Biopharmaceuticals Regulatory

HSMN NewsFeed - 1 Aug 2014
European Commission Grants Orphan Drug Designation to Soliris(R) (eculizumab) for the Treatment of Patients with Myasthenia Gravis (MG)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 30 Jul 2014
Study Shows that RapidArc(R) Radiosurgery Substantially More Efficient and Comparable in Quality to Gamma Knife(R) in the Treatment of Multiple Brain Metastases
Devices Oncology

HSMN NewsFeed - 28 Jul 2014
Aqua Pharmaceuticals, LLC Announces the U.S. Food and Drug Administration (FDA) Approval of ACTICLATE(TM) (doxycycline hyclate USP) Tablets, 150 mg and 75 mg
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Jul 2014
European Medicines Agency (EMA) Issues Positive Opinion, Recommends Full Approval of IMBRUVICA(R) (ibrutinib) for Treatment of Two Blood Cancers
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 25 Jul 2014
Bayer and Onyx Pharmaceuticals Report Phase 3 Trial Results of NEXAVAR(R) (sorafenib) in Patients with Advanced Breast Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Jul 2014
Salix and Pharming Announce FDA Approval of RUCONEST(R) for the Treatment of Acute Angioedema Attacks in Patients with Hereditary Angioedema (HAE)
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Jul 2014
Pfizer Announces Positive Top-Line Results From Phase 3 Study Of NONACOG ALFA (BeneFIX(R)) Once-Weekly Prophylaxis For Hemophilia B
Biopharmaceuticals

HSMN NewsFeed - 14 Jul 2014
Genentech’s Investigational Medicine Cobimetinib, Used in Combination with Zelboraf(R) (Vemurafenib), Helped People with Advanced Melanoma Live Significantly Longer Without Their Disease Worsening
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 Jun 2014
Flamel Technologies Announces FDA Approval of VAZCULEP
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Jun 2014
Ligand Partner GSK Announces Results of Phase 3 PETIT2 Study of Eltrombopag (Promacta(TM)/Revolade(TM)) in Pediatric Patients with Chronic Immune Thrombocytopenia
Biopharmaceuticals

HSMN NewsFeed - 12 Jun 2014
FDA approves Bayer's Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States
Biopharmaceuticals Radiology FDA

HSMN NewsFeed - 12 Jun 2014
SoluMatrix(R) Meloxicam Demonstrates Significant Efficacy at 30 Percent Lower Doses in the Treatment of Osteoarthritis
Biopharmaceuticals

HSMN NewsFeed - 10 Jun 2014
Avanir Pharmaceuticals Announces Positive Outcome of Phase IIIb COMPASS Trial: A Head-to-Head Study Comparing AVP-825 to Oral Sumatriptan for the Acute Treatment of Migraine
Biopharmaceuticals

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