Healthcare Sales & Marketing Network News: orphan drug designation

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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 - 18 Nov 2022
Synaptogenix Announces $15 Million Private Placement with Existing Investors
Biopharmaceuticals Regenerative Medicine Venture Capital

HSMN NewsFeed - 10 Nov 2022
BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS
Biopharmaceuticals Regenerative Medicine Neurology FDA

HSMN NewsFeed - 31 Oct 2022
Actinium Announces Positive Top-line Results from Pivotal Phase 3 SIERRA Trial of Iomab-B in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 21 Oct 2022
Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA(R) (aflibercept) Injection
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 15 Sep 2022
BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn(R) Phase 2 Progressive MS Trial in Multiple Sclerosis Journal
Regenerative Medicine Neurology

HSMN NewsFeed - 26 Aug 2022
Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Aug 2022
Aeglea BioTherapeutics Announces Leadership Transition and Corporate Restructuring
Biopharmaceuticals Personnel

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

HSMN NewsFeed - 8 Jul 2022
Sobi to license loncastuximab tesirine from ADC Therapeutics
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 23 Jun 2022
CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 May 2022
Promontory Therapeutics Appoints Johan Baeck, MD, as Executive Vice President and Chief Medical Officer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 18 Apr 2022
Nanoscope Therapeutics Appoints Pharma Industry Veteran Aaron Osborne, MBBS, as Chief Medical Officer and Chief Development Officer
Biopharmaceuticals Personnel

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

HSMN NewsFeed - 21 Mar 2022
NeuroSense Therapeutics Receives FDA Clearance of IND for PrimeC for the Treatment of ALS
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 14 Mar 2022
Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation from the FDA for the Treatment of T-Cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jan 2022
Nanoscope Therapeutics Announces FDA Clearance of IND for MCO-010 Gene Therapy in Stargardt Macular Degeneration Patients
Regenerative Medicine Ophthalmology FDA

HSMN NewsFeed - 12 Jan 2022
CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations for Bi-Specific Anti-CD19/CD20 CAR-T Cell Therapy for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Biopharmaceuticals Regenerative Medicine Oncology FDA

HSMN NewsFeed - 3 Jan 2022
Curis Adds Three New Executives to Management Team Strengthening Medical Affairs, Clinical Development and Clinical Operations
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 27 Dec 2021
FDA Authorizes Further NurOwn(R) Dosing Under Expanded Access Program
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 6 Dec 2021
Sapience Therapeutics Receives FDA Fast Track Designation for ST101 for the Treatment of Recurrent Glioblastoma Multiforme (GBM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Nov 2021
Viracta Therapeutics Announces Orphan Drug Designation Granted by FDA for its All-Oral Combination of Nanatinostat and Valganciclovir (Nana-val) for the Treatment of Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Nov 2021
Kintara Announces Changes to Executive Leadership Team
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 8 Nov 2021
FDA Grants Profounda Orphan Drug Designation Approval for Treatment of Invasive Candidiasis with Miltefosine
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Nov 2021
BrainStorm Cell Therapeutics Expands Leadership Team to Support Clinical Development and Medical Affairs
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 22 Sep 2021
Kintara Reports Topline Results from Phase 2 Clinical Study of VAL-083 as Adjuvant Therapy for Newly-Diagnosed GBM Patients
Biopharmaceuticals Oncology

HSMN NewsFeed - 16 Sep 2021
Sutro Biopharma Announces Expansion of Leadership Team
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 7 Sep 2021
RenovoRx Receives New 510(k) Clearance for its RenovoCath(R) Delivery System Designed for Targeted Treatment of Solid Tumors
Devices Drug Delivery Oncology FDA

HSMN NewsFeed - 27 Aug 2021
European Commission Approves BioMarin's VOXZOGO(R) (vosoritide) for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 Aug 2021
FDA Grants Lantern Pharma Orphan Drug Designation for Drug Candidate LP-184 in the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Aug 2021
Sutro Biopharma Appoints Jane Chung as Chief Commercial Officer
Biopharmaceuticals Oncology Personnel

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

HSMN NewsFeed - 2 Aug 2021
Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 Jul 2021
Elevar Therapeutics Announces New Appointments to Strengthen its Executive and Senior Leadership Teams
Biopharmaceutical Personnel

HSMN NewsFeed - 29 Jun 2021
FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme
Biopharmaceuticals Oncology FDA

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 - 25 Jun 2021
BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory

HSMN NewsFeed - 16 Jun 2021
Veralox Therapeutics Announces Closing Of $16.6 Million Series A Financing And Announces New Board Members
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 14 Jun 2021
FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Jun 2021
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 May 2021
AffyImmune Therapeutics' AIC100 Granted Fast Track Designation for Treating Thyroid Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 May 2021
FDA Grants Bold Therapeutics' BOLD-100 an Orphan Drug Designation (ODD) in the Treatment of Gastric Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Apr 2021
Curis Receives FDA Orphan Drug Designation for CA-4948 for the Treatment of AML and MDS
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Apr 2021
NLS Pharmaceutics Appoints Silvia Panigone, Ph.D. As Chief Operating Officer
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 30 Mar 2021
Biom Therapeutics Receives Orphan Drug Status for BIO017 from the U.S. FDA for the treatment of Angelman Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 30 Mar 2021
PTC Therapeutics Announces the European Approval of Evrysdi(TM) for the Treatment of Spinal Muscular Atrophy
Biopharmaceuticals Regulatory

HSMN NewsFeed - 22 Mar 2021
Sutro Biopharma Strengthens Leadership Through Management Promotions and Expansion of Clinical Advisory Board
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 17 Mar 2021
Peptilogics Strengthens Leadership Team with Three Strategic Appointments
Biopharmaceuticals Personnel

HSMN NewsFeed - 11 Mar 2021
Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 Mar 2021
BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia A
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Feb 2021
Protalix BioTherapeutics Enters into an Exclusive Partnership with SarcoMed USA to Develop alidornase alfa for the Treatment of Pulmonary Sarcoidosis and Related Respiratory Diseases Via Inhaled Delivery
Biopharmaceuticals Drug Delivery Licensing

HSMN NewsFeed - 28 Dec 2020
Elevar Therapeutics Announces Licensing Agreement with Inceptua Group for Commercialization of Apealea(R) (Paclitaxel Micellar) in Europe
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 22 Dec 2020
Soligenix Announces Topline Results from its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients
Biopharmaceuticals Oncology

HSMN NewsFeed - 18 Dec 2020
Polaryx Therapeutics Receives Both Rare Pediatric Disease and Orphan Drug Designations for the Treatment of Niemann Pick Disease Types A and B With PLX-300
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 15 Dec 2020
Lilly Announces Agreement to Acquire Prevail Therapeutics
Biopharmaceuticals Neurology Mergers & Acquisitions

HSMN NewsFeed - 30 Nov 2020
PTC Therapeutics Announces Initiation of Global Phase 3 Clinical Trial to Evaluate Vatiquinone in Friedreich Ataxia
Biopharmaceuticals

HSMN NewsFeed - 18 Nov 2020
Sutro Biopharma Announces the Appointment of Diana Landa as Vice President of Regulatory Affairs and Annie Chang as Head of Investor Relations
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 2 Nov 2020
CARsgen Therapeutics Closes a USD 186 Million Series C Equity Financing to Accelerate Global Clinical Trials of its Cell Therapy Product Candidates
Biopharmaceuticals Venture Capital

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 - 5 Oct 2020
CARsgen Therapeutics Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Oct 2020
BioMarin, Pioneer in Phenylketonuria (PKU) and Gene Therapy, Receives FDA Fast Track Designation for PKU Investigational Gene Therapy, BMN 307
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Sep 2020
AbbVie Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 24 Sep 2020
Leap Therapeutics Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Sep 2020
Relief and NeuroRx Announce Partnership for Global Commercialization of RLF-100(TM) and Selection of Commercial Partners
Biopharmaceuticals

HSMN NewsFeed - 11 Sep 2020
Targazyme Appoints Jim Caggiano as CEO
Biopharmaceuticals Personnel

HSMN NewsFeed - 7 Sep 2020
Ascentage Pharma's Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Aug 2020
Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft(R) Regenerative Skin Tissue for Treatment of Adults with Deep Partial-thickness Thermal Burns
Biopharmaceuticals Regenerative Medicine FDA

HSMN NewsFeed - 6 Aug 2020
FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure
Biopharmaceuticals Drug Delivery FDA

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 - 11 Jun 2020
CNS Announces the FDA has Granted Orphan Drug Designation for Brain Cancer Drug Berubicin
Biopharmaceuticals Oncology Neurology FDA

HSMN NewsFeed - 10 Jun 2020
F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections
Biopharmaceuticals FDA

HSMN NewsFeed - 21 May 2020
Sutro Biopharma Expands Senior Management with the Additions of Vice President of Clinical Development and Vice President of Finance and Controller
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 19 May 2020
Amplyx Pharmaceuticals Adds Pfizer and Adage to Series C Financing, Bringing Total to over 90 Million
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 27 Apr 2020
CARsgen Therapeutics Receives Positive EMA Opinion on Orphan Drug Designation for Fully Human Anti-BCMA CAR-T Cells (CT053) for the Treatment of Multiple Myeloma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 8 Apr 2020
Viracta Receives Welcome FDA Guidance at Type C Meeting for the Treatment of EBV-Associated Lymphomas
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Apr 2020
OxThera Announces Completion of Recruitment in Phase 3 ePHex Study With Oxabact(R) in Patients With Primary Hyperoxaluria
Biopharmaceuticals

HSMN NewsFeed - 18 Mar 2020
Biohaven's Verdiperstat Receives Fast Track Designation For The Treatment Of Multiple System Atrophy
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Mar 2020
Pliant Therapeutics Raises $100 Million in Series C Financing to Advance Therapies for Fibrotic Diseases
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 24 Feb 2020
Lipocine Announces Regulatory Path Forward for TLANDO(TM) Resubmission
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Feb 2020
Sutro Biopharma Expands Senior Management Team with the Appointments of Vice President of Immunobiology and Vice President of Business Development
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 29 Jan 2020
Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Jan 2020
vasopharm Completes Patient Enrollment for Phase III Traumatic Brain Injury Trial (NOSTRA)
Biopharmaceuticals Neurology

HSMN NewsFeed - 13 Jan 2020
Dova Granted Orphan Drug Designation for Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 Jan 2020
Altavant Sciences Acquires Onspira Therapeutics, Adding a Potentially Life-Saving Treatment for Post-Lung Transplant Patients to the Altavant Pipeline
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 26 Dec 2019
OBI Pharma Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Dec 2019
European Medicines Agency Validates BioMarin's Marketing Authorization Application for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A
Biopharmaceuticals Regulatory

HSMN NewsFeed - 18 Nov 2019
Allergan(R) Announces First Annual National BOTOX(R) Cosmetic (onabotulinumtoxinA) Day
Biopharmaceuticals Dermatology

HSMN NewsFeed - 15 Nov 2019
Jazz Pharmaceuticals Receives Positive CHMP Opinion for Solriamfetol to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 Nov 2019
Lipocine Receives Complete Response Letter for TLANDO(TM) from U.S. FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Oct 2019
SFA Therapeutics, Inc. Receives an FDA Orphan Drug Designation (ODD) for SFA001 in the Treatment of Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Oct 2019
Pliant Therapeutics Announces Strategic Collaboration to Develop Novel Therapies for NASH and Fibrotic Diseases
Biopharmaceuticals Licensing

HSMN NewsFeed - 27 Aug 2019
Lipocine Announces Trial Date in Lipocine's Infringement Lawsuit Against Clarus Therapeutics and Will Seek a Permanent Injunction
Biopharmaceuticals Litigation

HSMN NewsFeed - 20 Aug 2019
Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
Biopharmaceuticals FDA

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 - 31 Jul 2019
Biohaven Enrolls First Patient In Phase 3 Clinical Trial Of Verdiperstat, Oral Myeloperoxidase Inhibitor, For The Treatment Of Multiple System Atrophy
Biopharmaceuticals Neurology

HSMN NewsFeed - 23 Jul 2019
Lipocine Receives FDA Clearance for Clinical Testing its NASH Candidate, LPCN 1144, in Expanded Target Population
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jul 2019
Geron Enhances Oncology Expertise to Advance Corporate Objectives
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 19 Jul 2019
Aridis Pharmaceuticals Receives Orphan Drug Designation From the European Medicines Agency for AR-501
Biopharmaceuticals Regulatory

HSMN NewsFeed - 20 Jun 2019
OxThera Initiates Extension Part of a Phase 3 Study of Oxabact in Primary Hyperoxaluria
Biopharmaceuticals

HSMN NewsFeed - 6 Jun 2019
Palatin Technologies Granted FDA Orphan Drug Designation -- PL-8177 for the Treatment of Non-Infectious Uveitis
Biopharmaceuticals Ophthalmology FDA

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 - 21 May 2019
DelMar Pharmaceuticals Announces Expansion of Scientific Advisory Board
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 10 May 2019
NeuroVive's IND for Clinical Development of NeuroSTAT Approved by FDA
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 8 May 2019
ReNeuron Provides Business Update and Results Notification
Regenerative Medicine Ophthalmology Neurology

HSMN NewsFeed - 16 Apr 2019
Viracta Receives Orphan Drug Designation from the US FDA for its Lead Epigenetic Drug Candidate Nanatinostat for EBV-Associated Cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Apr 2019
Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Apr 2019
DelMar Pharmaceuticals Welcomes Dr. John de Groot, Chairman, ad interim of the Department of Neuro-Oncology at MD Anderson Cancer Center, as founding member of the Company's Scientific Advisory Board
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 26 Mar 2019
Breath Therapeutics Announces Initiation of Global Phase 3 Trials for the Treatment of Bronchiolitis Obliterans Syndrome
Biopharmaceuticals

HSMN NewsFeed - 21 Mar 2019
RegeneRx Announces New Board Member
Biopharmaceuticals Personnel

HSMN NewsFeed - 21 Mar 2019
Enzyvant's Investigational Farber Disease Enzyme Replacement Therapy, RVT-801, Receives FDA Fast Track and Rare Pediatric Disease Designations
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Feb 2019
Lipocine Inc. Announces FDA Clearance of IND to Commence Phase 2 Study of LPCN 1144 in Biopsy Confirmed NASH Subjects
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Feb 2019
FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Feb 2019
BioLineRx Receives Orphan Drug Designation From the FDA for its Lead Therapeutic Candidate BL-8040 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Jan 2019
Aldeyra Therapeutics Expands Retinal Disease Pipeline with Acquisition of Helio Vision
Biopharmaceuticals Ophthalmology Mergers & Acquisitions

HSMN NewsFeed - 29 Jan 2019
Sutro Biopharma Expands Leadership Team with Appointment of Vice President of Chemistry
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 17 Jan 2019
Asceneuron Appoints Peter Van Vlasselaer as Chairman
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 16 Jan 2019
Therachon is Granted Orphan Drug Designation by US FDA for Apraglutide for the Treatment of Short Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 19 Dec 2018
Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib in Progeria and Progeroid Laminopathies
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Dec 2018
PharmaEssentia and AOP Orphan Receive Positive CHMP Opinion For Besremi(TM) (Ropeginterferon alfa-2b) For Treatment Of Polycythemia Vera (PV) In EU
Biopharmaceuticals Regulatory

HSMN NewsFeed - 10 Dec 2018
Merck KGaA, Darmstadt, Germany Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 Dec 2018
Neurelis Announces Acquisition Of Aegis Therapeutics, A Leading Drug Delivery Technology Company
Biopharmaceuticals Drug Delivery Mergers & Acquisitions

HSMN NewsFeed - 26 Nov 2018
Biohaven Announces FDA Acceptance of 505(b)(2) NDA Filing for BHV-0223, a Novel Sublingual Delivery Form of Riluzole for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Biopharmaceuticals Neurology Drug Delivery FDA

HSMN NewsFeed - 21 Nov 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-888 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 20 Nov 2018
FDA Approves Gamifant(R) (emapalumab), the First and Only Treatment for Primary Haemophagocytic Lymphohistiocytosis (HLH)
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Nov 2018
Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Primary Sclerosing Cholangitis
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Nov 2018
Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol as a Treatment to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adult Patients with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals Regulatory

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
Senhwa Biosciences Silmitasertib filed IND of Basal Cell Carcinoma approved by FDA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Oct 2018
Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 2019
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Oct 2018
Trovagene Announces Exclusive License Agreement with MIT for Combination Therapy of Anti-Androgens and Polo-like Kinase Inhibitors in Prostate Cancer
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 25 Sep 2018
Neurelis Files New Drug Application with the FDA for VALTOCO(TM) Nasal Spray, an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
Biopharmaceuticals Neurology Drug Delivery FDA

HSMN NewsFeed - 25 Sep 2018
Dr. Dmitry Samarsky Joins Sirnaomics Senior Management Team as Chief Technology Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 19 Sep 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Sep 2018
Samumed And United Therapeutics Announce North American License Agreement For Samumed's IPF Drug Candidate
Biopharmaceuticals Licensing

HSMN NewsFeed - 5 Sep 2018
ARMGO Pharma Receives FDA Orphan Drug Designation for ARM210/S48168 for the Treatment of Ryanodine Receptor Type 1 Related Myopathies
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Sep 2018
Cablivi(TM) (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura (aTTP)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 29 Aug 2018
Trovagene Announces European Commission Grants Orphan Drug Designation to Onvansertib (PCM-075) for Treatment of Acute Myeloid Leukemia in Europe
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 27 Aug 2018
Cantex Pharmaceuticals, Inc. Receives FDA Fast Track Designation For CX-01 For The Treatment Of Patients Over Age 60 With Newly Diagnosed Acute Myeloid Leukemia (AML)
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 - 21 Aug 2018
Audentes Announces Regenerative Medicine Advanced Therapy (RMAT) Designation Granted by the FDA to AT132 for the Treatment of X-Linked Myotubular Myopathy
Biopharmaceuticals Regenerative Medicine FDA

HSMN NewsFeed - 16 Aug 2018
Rafael Pharmaceuticals Receives FDA Orphan Drug Designation of CPI-613 for the Treatment of Peripheral T-Cell Lymphoma (PTCL)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Aug 2018
Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Idiopathic Pulmonary Fibrosis
Biopharmaceuticals 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 - 9 Jul 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA

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 - 3 Jul 2018
MabVax Therapeutics Grants Exclusive Sublicense to Y-mAbs Therapeutics for Patented Neuroblastoma Vaccine
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 27 Jun 2018
Revive Therapeutics Announces FDA Grants Orphan Drug Designation for Cannabidiol in the Treatment of Autoimmune Hepatitis
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Jun 2018
Audentes Announces Priority Medicines (PRIME) Designation Granted by the European Medicines Agency to AT132 for the treatment of X-Linked Myotubular Myopathy
Biopharmaceuticals Regulatory

HSMN NewsFeed - 4 Jun 2018
Blueprint Medicines and CStone Pharmaceuticals Announce Exclusive Collaboration and License Agreement to Develop and Commercialize Avapritinib, BLU-554 and BLU-667 in Greater China
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 29 May 2018
TrioxBio Announces Fast Track Designation Granted by U.S. FDA to Raviten(R) for the Treatment of Intradialytic Hypotension
Biopharmaceuticals FDA

HSMN NewsFeed - 29 May 2018
U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 May 2018
Eiger Announces Expanded License Agreement with Merck for Investigational Candidate Lonafarnib and Collaboration with The Progeria Research Foundation (PRF)
Biopharmaceuticals Licensing Distribution

HSMN NewsFeed - 16 May 2018
Protagonist Therapeutics Appoints Bryan Giraudo to Board of Directors
Biopharmaceuticals Gastroenterology Personnel

HSMN NewsFeed - 8 May 2018
Daiichi Sankyo Announces Single Agent Quizartinib Significantly Prolongs Overall Survival Compared with Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations (QuANTUM-R Study)
Biopharmaceuticals Oncology

HSMN NewsFeed - 1 May 2018
SCYNEXIS's Oral SCY-078 Receives FDA QIDP and Fast Track Designations for the Treatment of VVC and Prevention of Recurrent VVC
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Apr 2018
Lin BioScience Announces FDA Orphan Drug Designation for LBS-007 for the Treatment of Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 20 Apr 2018
SELLAS Life Sciences Announces Appointment of Gene Mack as Chief Financial Officer & Treasurer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 20 Apr 2018
UCB to Expand Epilepsy Portfolio With Strategic Acquisition of Midazolam Nasal Spray From Proximagen
Biopharmaceuticals Neurology Acquisitions

HSMN NewsFeed - 9 Apr 2018
Intezyne Promotes Adam Carie, PhD to Director, Product Development
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 26 Mar 2018
Bayer Announces Completion of Rolling Submission of New Drug Application in the U.S. for Larotrectinib for the Treatment of TRK Fusion Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 20 Mar 2018
Ocugen Reports Positive Phase 2 Clinical Results Demonstrating Proof-of-Concept for its Novel Combination Therapy for Dry Eye Disease
Biopharmaceuticals Ophthalmology

HSMN NewsFeed - 19 Mar 2018
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Designation from the FDA for APX001
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Mar 2018
Intezyne Taps Veteran Banker E. Russell McAllister as President and CEO
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 15 Mar 2018
Ionis and Akcea Partner to Commercialize Inotersen for hATTR
Biopharmaceuticals Licensing

HSMN NewsFeed - 2 Mar 2018
Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Feb 2018
Kazia Receives FDA Orphan Designation for GDC-0084
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Feb 2018
Appointment of Jonathan E. Gold as Interim Chief Financial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 30 Jan 2018
FDA Grants Orphan Drug Designation to Dauntless Pharmaceuticals' DP1038 for the Treatment of Acromegaly
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jan 2018
Astellas and Vical Announce Top-Line Results for Phase 3 Trial of Cytomegalovirus Vaccine ASP0113 in Hematopoietic Stem Cell Transplant Recipients
Biopharmaceuticals

HSMN NewsFeed - 29 Dec 2017
Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for AZEDRA(R) (iobenguane I 131) in Pheochromocytoma and Paraganglioma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Dec 2017
GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex(R) (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 27 Dec 2017
Protalix BioTherapeutics� PRX-102 Granted Orphan Drug Designation by the European Commission
Biopharmaceuticals Regulatory

HSMN NewsFeed - 26 Dec 2017
Organovo Receives Orphan Designation From U.S. FDA for 3D Bioprinted Therapeutic Liver Tissue Treatment of Alpha-1 Antitrypsin Deficiency
Regenerative Medicine FDA

HSMN NewsFeed - 26 Dec 2017
Mallinckrodt To Acquire Sucampo Pharmaceuticals For Approximately $1.2 Billion
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 21 Dec 2017
Jazz Pharmaceuticals Submits New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Dec 2017
Neurotrope Appoints Charles S. Ryan as Chief Executive Officer
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 13 Dec 2017
Kangen Pharmaceuticals Co., Ltd. Announces Acquisition Of KC Specialty Therapeutics
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 12 Dec 2017
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Dec 2017
Eyevensys Appoints Dr. Patricia Zilliox as Chief Executive Officer
Biopharmaceuticals Ophthalmology Personnel

HSMN NewsFeed - 11 Dec 2017
Polaryx Therapeutics Receives Orphan Drug Designation From the US FDA for the Treatment of Neuronal Ceroid Lipofuscinoses With PLX-100
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 6 Dec 2017
Sirnaomics' Leading siRNA Therapeutic Candidate, STP705, Granted Orphan Designation for Treatment of Cholangiocarcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Dec 2017
Spruce Biosciences Receives FDA Orphan Drug Designation for SPR001 for the Treatment of Congenital Adrenal Hyperplasia
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Dec 2017
TesoRx Pharma And ASKA Pharmaceutical Expand Territory And Scope Of Partnering Agreement For TesoRx's Oral Testosterone Product
Biopharmaceuticals Distribution

HSMN NewsFeed - 27 Nov 2017
Stealth BioTherapeutics Granted Fast Track Designation for the Treatment of Barth Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Nov 2017
FDA Approves New Treatment to Prevent Bleeding in Certain Patients with Hemophilia A
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Nov 2017
Artemis Therapeutics Receives Orphan Drug Designation From U.S. Food And Drug Administration For Artemisone For The Treatment Of Malaria
Biopharmaceuticals FDA

HSMN NewsFeed - 31 Oct 2017
Mitosol(R)'s Orphan Drug Designation is Expanded for All Glaucoma Surgery
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 26 Oct 2017
FDA Grants Breakthrough Therapy Designation for BioMarin's Valoctocogene Roxaparvovec (formerly BMN 270), an Investigational Gene Therapy for Hemophilia A
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Oct 2017
Dr. Bastian Dehmel Appointed CMO of OxThera
Biopharmaceuticals Personnel

HSMN NewsFeed - 6 Oct 2017
Intezyne Closes Oversubscribed $10M Series A Financing to Drive Rapid Oncology Portfolio Development
Biopharmaceuticals Oncology Venture Capital Personnel

HSMN NewsFeed - 2 Oct 2017
Mallinckrodt Licenses Inhaled Xenon Gas Therapy Development Product
Biopharmaceuticals Licensing

HSMN NewsFeed - 11 Sep 2017
Advicenne Announces Positive Pivotal Phase III Clinical Data for ADV7103 in Adults and Children Suffering from distal Renal Tubular Acidosis (dRTA)
Biopharmaceuticals

HSMN NewsFeed - 6 Sep 2017
RXi Pharmaceuticals Announces Completion of Enrollment of Phase 2 Clinical Trial with Samcyprone for Cutaneous Warts
Biopharmaceuticals Dermatology

HSMN NewsFeed - 5 Sep 2017
Eiger Announces FDA Orphan Drug Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Sep 2017
FDA Grants Orphan Drug Status to Cellect's ApoGraft(TM) for Acute GvHD and Chronic GvHD
Regenerative Medicine FDA

HSMN NewsFeed - 4 Sep 2017
Eyevensys Appoints Dr Ronald R. Buggage as Chief Medical Officer
Biopharmaceuticals Ophthalmology Personnel

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

HSMN NewsFeed - 29 Aug 2017
ARMO BioSciences Raises $67 Million in a Series C-1 Financing
Biopharmaceuticals Oncology Venture Capital Personnel

HSMN NewsFeed - 24 Aug 2017
Thomas Eklund New Chairman of Pharmalink
Biopharmaceuticals Personnel

HSMN NewsFeed - 23 Aug 2017
Epygenix Therapeutics Receives US FDA Orphan Drug Designation for EPX-300 for the Treatment of Patients With Dravet Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 22 Aug 2017
Jupiter Orphan Therapeutics Receives Orphan Drug Designation for its Trans-Resveratrol Product JOTROL for Treatment of Friedreich's Ataxia
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 15 Aug 2017
Pharmalink Strengthens Its Management Team. Appoints New Chief Financial Officer and Head of Communications
Biopharmaceuticals Personnel

HSMN NewsFeed - 9 Aug 2017
Ocugen Receives FDA Orphan Drug Designation for OCU300 (brimonidine tartrate) for the Treatment of Ocular Graft Versus Host Disease
Biopharmaceuticals Ophthalmology 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 - 18 Jul 2017
Capricor Receives Rare Pediatric Disease Designation from FDA for CAP-1002 for Patients with Duchenne Muscular Dystrophy
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Jul 2017
The FDA has Accepted an Orphan Designation Request for use of Truveta Administered Intranasally Submitted by Axium Pharmaceuticals Inc.
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 11 Jul 2017
DelMar Pharmaceuticals Appoints Saiid Zarrabian to the Board of Directors and Names Dr. Erich Mohr as Chairman
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 10 Jul 2017
Gamida Cell Inc. Names Ronit Simantov, M.D. as Chief Medical Officer
Regenerative Medicine Personnel

HSMN NewsFeed - 6 Jul 2017
Biohaven's BHV-5000 Receives Orphan Drug Designation from the FDA in Rett Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 5 Jul 2017
Recordati Rare Diseases Introduces New PANHEMATIN(R) (Hemin for Injection) Dosage Strength for Treatment of Acute Intermittent Porphyria (AIP)
Biopharmaceuticals Product Launch

HSMN NewsFeed - 5 Jul 2017
Matthew Gantz Appointed CEO of OxThera
Biopharmaceuticals Personnel

HSMN NewsFeed - 28 Jun 2017
FDA Grants Profounda Inc. Orphan Drug Designation for treatment of Granulomatous Amebic Encephalitis (GAE) with Miltefosine
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jun 2017
DelMar Pharmaceuticals Receives Institutional Review Board Approval for Pivotal Phase 3 Clinical Trial of VAL-083 in Refractory GBM
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 Jun 2017
FDA Accepts Rigel's New Drug Application for TAVALISSE(TM) (fostamatinib disodium) for the Treatment of Chronic ITP
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jun 2017
Complete Efficacy and Long-Term Follow-Up Safety Results from SGX942 Phase 2 Oral Mucositis Clinical Trial to be Presented at the 2017 Multinational Association for Supportive Care in Cancer Conference
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Jun 2017
Novoteris, LLC Receives FDA and Health Canada Clearance to Start a Phase 2 Clinical Trial of Its Thiolanox(R) Nitric Oxide for the Treatment of Cystic Fibrosis
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 5 Jun 2017
Gamida Cell Appoints Nobel Prize Laureate Professor Roger Kornberg and Immune Oncology Expert Dr. Michael Perry to its Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 23 May 2017
Ultragenyx Announces Recombinant Human Beta-Glucuronidase Biologics License Application and Marketing Authorization Application Filed and Accepted for Review; FDA Grants Priority Review Status
Biopharmaceuticals FDA

HSMN NewsFeed - 18 May 2017
Pharmalink AB Announces the Appointment of a New Chief Executive Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 15 May 2017
Ionis Pharmaceuticals Announces Phase 3 NEURO-TTR Study of Inotersen (IONIS-TTR Rx) Meets Both Primary Endpoints
Biopharmaceuticals

HSMN NewsFeed - 11 May 2017
Xencor's Lead Drug Candidate, XmAb5871, Receives Orphan Drug Designation from FDA for Treatment of IgG4-Related Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 10 May 2017
Savara Announces Expedited U.S. Molgradex Development Strategy
Biopharmaceuticals FDA

HSMN NewsFeed - 3 May 2017
Soligenix Receives FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 May 2017
NEUROTROPE Announces Positive Top-Line Results From Phase 2 Study of Bryostatin-1 for Moderate to Severe Alzheimer's Disease
Biopharmaceuticals Neurology

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 - 27 Apr 2017
Rigel Announces Tavalisse(TM) as Proprietary Name for Fostamatinib in the United States
Biopharmaceuticals Oncology

HSMN NewsFeed - 25 Apr 2017
PhaseRx Receives Positive Opinion for Orphan Drug Designation for PRX-OTC from European Medicines Agency
Biopharmaceuticals Regulatory

HSMN NewsFeed - 25 Apr 2017
Epygenix Therapeutics Receives Orphan Drug Designation From the U.S. FDA for EPX-100 and EPX-200 in the Treatment of Patients With Dravet Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 19 Apr 2017
Advaxis Appoints Anthony Lombardo as Chief Business Officer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 19 Apr 2017
CytRx Announces FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in Soft Tissue Sarcomas
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Apr 2017
Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP
Biopharmaceuticals

HSMN NewsFeed - 4 Apr 2017
Teva Announces FDA Approval of AUSTEDO(TM) (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington�s Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 28 Mar 2017
ONL Therapeutics Strengthens Leadership with Addition to Board of Directors and Expansion of Operations Team
Biopharmaceuticals Ophthalmology Personnel

HSMN NewsFeed - 27 Mar 2017
Dinutuximab beta receives positive recommendation for the treatment of high-risk neuroblastoma in Europe
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 22 Mar 2017
Moleculin Receives Orphan Drug Designation for Annamycin for the Treatment of Acute Myeloid Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Mar 2017
Eyevensys Appoints Leading Life Sciences Executive and Ophthalmology Expert Dr. Garth Cumberlidge as Chairman
Biopharmaceuticals Devices Ophthalmology Personnel

HSMN NewsFeed - 15 Mar 2017
Julie G. Anderson Joins BioVie as Independent Director and Investor
Biopharmaceuticals Personnel

HSMN NewsFeed - 2 Mar 2017
EnGeneIC Receives FDA Orphan Drug Designation for Targeted EDV(TM) Nanocells to Treat Glioblastoma Multiforme
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Mar 2017
Sangamo Therapeutics Receives Orphan Drug Designation from the FDA for SB-913 Genome Editing Treatment for MPS II
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Feb 2017
aTyr Pharma Receives U.S. FDA Orphan Drug Designation for the Treatment of Limb Girdle Muscular Dystrophy with Resolaris(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Feb 2017
Denovo Biopharma plans to launch a Global Phase 3 Trial of DB102 (Enzastaurin) in Diffuse Large B-cell Lymphoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 15 Feb 2017
Lipocine Announces the Promotion of Gregory Bass to Chief Commercial Officer
Biopharmaceuticals Drug Delivery Personnel

HSMN NewsFeed - 3 Jan 2017
Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone to Treat Fragile X Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 29 Dec 2016
Provectus Biopharmaceuticals Terminates Peter Culpepper as Interim CEO and COO
Biopharmaceuticals Personnel

HSMN NewsFeed - 19 Dec 2016
FDA Orphan Drug Designation Granted to Profounda Inc. for the Treatment of Acanthamoeba Keratitis with Miltefosine
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 16 Dec 2016
Gr�nenthal Receives Breakthrough Therapy Designation From U.S. FDA for Neridronic Acid for the Treatment of CRPS
Biopharmaceuticals FDA

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 - 29 Nov 2016
OxThera Raises EUR 32 Million to Complete Development of Oxabact(R) for Treatment of Primary Hyperoxaluria
Biopharmaceuticals Venture Capital

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

HSMN NewsFeed - 23 Nov 2016
Neurotrope Issues Statement On Eli Lilly's Solanezumab
Biopharmaceuticals Neurology

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

HSMN NewsFeed - 31 Oct 2016
European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology Regulatory

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

HSMN NewsFeed - 19 Oct 2016
SELLAS(TM) Life Sciences Appoints Former Barclays Biotechnology Research Analyst as Chief Business and Strategy Officer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 18 Oct 2016
True North Therapeutics Announces $45 Million Series D Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 18 Oct 2016
Corbus Pharmaceuticals Receives Orphan Designation for Resunab for the Treatment of Cystic Fibrosis in the European Union
Biopharmaceuticals Regulatory

HSMN NewsFeed - 4 Oct 2016
EUSA Pharma Acquires Global Rights to Neuroblastoma Treatment Isqette(R) (Dinutuximab Beta) from Apeiron Biologics
Biopharmaceuticals Oncology Acqusitions

HSMN NewsFeed - 28 Sep 2016
Dr. Daniel Alkon Appointed President of Neurotrope, Inc.
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 20 Sep 2016
Advanced Accelerator Applications Announces Revised EMA Review Timeline for Lutathera(R)
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 16 Sep 2016
CHMP Recommends Approval of Lilly's Olaratumab, in Combination with Doxorubicin, for Advanced Soft Tissue Sarcoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 25 Aug 2016
Sunesis Announces Publication in "Drugs" Detailing Molecular and Pharmacologic Properties of Vosaroxin
Biopharmaceuticals Oncology

HSMN NewsFeed - 18 Aug 2016
FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Aug 2016
Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa(TM) (andexanet alfa)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Aug 2016
AstraZeneca Provides Update On Phase III Trial Of Selumetinib In Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Aug 2016
Takeda Receives Marketing Authorization in Canada for NINLARO(TM) (ixazomib) in Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 8 Aug 2016
Inspyr Therapeutics Appoints Ronald Shazer, M.D., as Senior Vice President and Chief Medical Officer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 5 Aug 2016
Neurotrope Announces Changes to the Board of Directors and Management
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 4 Aug 2016
DNAtrix Awarded FDA Orphan Products Development Grant for DNX-2401
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Aug 2016
Inspyr Therapeutics Appoints Christopher Lowe Chief Executive Officer and Director
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 28 Jul 2016
Caladrius Biosciences Receives FDA Fast Track Designation for CLBS03 to Treat Recent Onset Type 1 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 12 Jul 2016
Advaxis Appoints Ranya Dajani as Vice President, Corporate Development
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 29 Jun 2016
Biostage Files for FDA Orphan Drug Designation for Cellspan(TM) Esophageal Implant
Regenerative Medicine FDA

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 - 27 Jun 2016
GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex(R) (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome
Biopharmaceuticals

HSMN NewsFeed - 21 Jun 2016
Neurotrope Appoints Paula T. Trzepacz, M.D. as Executive Vice President and Chief Medical Officer
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 21 Jun 2016
Savara Pharmaceuticals Acquires Serendex Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 10 Jun 2016
Raptor Pharmaceutical Announces Presentation of New Data Analyses from a Phase 3 Study of QUINSAIR(TM) at the 39th European Cystic Fibrosis Conference
Biopharmaceuticals

HSMN NewsFeed - 2 Jun 2016
FDA Grants Orphan Drug Designation to Debiopharm International SA's IAP Inhibitor Debio 1143 in the Treatment of Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 May 2016
Jazz Pharmaceuticals And Celator Pharmaceuticals Announce Agreement For Jazz Pharmaceuticals To Acquire Celator For $30.25 Per Share
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 17 May 2016
Catalyst Pharmaceuticals Announces Reduction in Workforce as Part of Operating Expense Management Plan
Biopharmaceuticals

HSMN NewsFeed - 21 Apr 2016
FDA Grants Orphan Drug Designation For VAL-083 In Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Apr 2016
New Analyses of the Phase 3 POISE Trial of Ocaliva(TM) (Obeticholic Acid) for the Treatment of PBC Presented at EASL
Biopharmaceuticals

HSMN NewsFeed - 11 Apr 2016
GW Pharmaceuticals Initiates Phase 3 Pivotal Study in Tuberous Sclerosis Complex
Biopharmaceuticals Neurology

HSMN NewsFeed - 15 Mar 2016
Heart Metabolics Announces Multiple Senior Appointments To Management Team
Biopharmaceuticals Cardiology Personnel

HSMN NewsFeed - 14 Mar 2016
ProNAi Therapeutics Granted Orphan Drug Designation for PNT2258 for the Treatment of Diffuse Large B-Cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 Mar 2016
Huya Bioscience International Expands Senior Management Team
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 1 Mar 2016
FLAG Therapeutics Announces the Granting of Orphan Drug Designation to FLAG-003 in both the US and EU for the Treatment of Glioma
Biopharmaceuticals Oncology FDA Regulatory

HSMN NewsFeed - 1 Mar 2016
Savara Pharmaceuticals Completes $20 Million Round of Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 26 Feb 2016
Catalyst Pharmaceuticals Appoints Brian Elsbernd as Senior Vice President of Legal and Compliance
Biopharmaceuticals Personnel

HSMN NewsFeed - 26 Feb 2016
AbbVie Receives EMA Orphan Drug Designation for Investigational Compound Venetoclax for the Treatment of Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 17 Feb 2016
Catalyst Pharmaceuticals Receives "Refusal to File" Letter From the FDA on Its NDA for Firdapse
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Feb 2016
Apellis Completes $47 Million Series D Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 10 Feb 2016
Amarantus Receives Orphan Drug Designation From the US FDA for Eltoprazine in the Treatment of Parkinson's Disease Levodopa-Induced Dyskinesia
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 5 Feb 2016
Amarantus Requests Rare Pediatric Disease Designation from US FDA for MANF in the Treatment of Retinitis Pigmentosa
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 3 Feb 2016
TapImmune Granted Fast Track Designation by U.S. Food & Drug Administration for its Lead Vaccine TPIV 200 in the Treatment of Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 Feb 2016
Emmaus Life Sciences Announces Management Promotions
Biopharmaceuticals Personnel

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 - 22 Jan 2016
Cellceutix Releases Data Used in Receiving FDA Orphan Drug Designation of Kevetrin for Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Jan 2016
vasopharm Announces EUR 20 Million Fundraising to Progress Treatment for Traumatic Brain Injury
Biopharmaceuticals Neurology Venture Capital

HSMN NewsFeed - 19 Jan 2016
Thetis Receives Orphan Drug Designation for TP-252 in Familial Adenomatous Polyposis
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Jan 2016
Zambon Launches Xadago(R) (Safinamide) in Switzerland for Patients with Parkinson�s Disease
Biopharmaceuticals Neurology Product Launch

HSMN NewsFeed - 5 Jan 2016
Ionis Pharmaceuticals Receives Orphan Drug Designation from the US FDA for IONIS-HTT Rx for the Treatment of Patients with Huntington's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 29 Dec 2015
Amarantus Requests Rare Pediatric Disease and Orphan Drug Designations from US FDA for Engineered Skin Substitute in the Treatment of Giant Congenital Melanocytic Nevi
Devices Regenerative Medicine Dermatology FDA

HSMN NewsFeed - 8 Dec 2015
Ignyta Receives Orphan Drug Designation in the European Union for Entrectinib for the Treatment of Neuroblastoma
Biopharmaceuticals Oncology Regulatory

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

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 - 19 Nov 2015
Triphase Accelerator Corporation Announces FDA Orphan Drug Designation for Marizomib in Malignant Glioma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Nov 2015
Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 Nov 2015
RetroSense Therapeutics Raises $6 million in an Over-Subscribed Series B Financing to Advance Clinical Development of Lead Product RST-001 for Retinitis Pigmentosa
Biopharmaceuticals Ophthalmology Venture Capital

HSMN NewsFeed - 10 Nov 2015
Seres Therapeutics Appoints Kurt Graves to Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 2 Nov 2015
Shire to Acquire Dyax Corp, Expanding and Extending Industry-Leading Hereditary Angioedema (HAE) Portfolio
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 23 Oct 2015
Spectrum Pharmaceuticals Receives Complete Response Letter (CRL) from U.S. Food and Drug Administration (FDA) for EVOMELA(TM) (melphalan) for Injection
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Sep 2015
Blueprint Medicines Receives FDA Orphan Drug Designation for Novel Drug Candidate for Treatment of Hepatocellular Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Sep 2015
Merck and Pfizer Announce FDA Orphan Drug Designation for Investigational Immunotherapy Avelumab in Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Sep 2015
Cerulean Appoints David R. Walt, Ph.D. to Board of Directors
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 15 Sep 2015
Makindus Bolsters Management Team with Appointment of Michael Celano as Chief Financial Officer
Biopharmaceuticals Ophthalmology Personnel

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 - 10 Sep 2015
Lori Kunkel, M.D., Joins Tocagen's Board of Directors
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 31 Aug 2015
FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Aug 2015
Mirati Therapeutics And MedImmune Partner On Immuno-Oncology Combination In Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 4 Aug 2015
Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol for the Treatment of Infantile Spasms
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 27 Jul 2015
European Medicines Agency Validates and Grants Accelerated Assessment of Marketing Authorization Application for Empliciti (elotuzumab) For the Treatment of Multiple Myeloma in Patients Who Have Received One or More Prior Therapies
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 Jul 2015
GenSight Biologics Closes $36 Million Series B Preferred Stock Financing
Biopharmaceuticals Ophthalmology Venture Captial

HSMN NewsFeed - 22 Jul 2015
AstraZeneca Provides Update On Selumetinib In Uveal Melanoma
Biopharmaceuticals Oncology Ophthalmology

HSMN NewsFeed - 15 Jul 2015
Raptor Pharmaceutical Announces Management Changes
Biopharmaceuticals Personnel

HSMN NewsFeed - 6 Jul 2015
Strensiq(R) (asfotase alfa) Receives Marketing Approval in Japan for Treatment of Patients with Hypophosphatasia (HPP)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 2 Jul 2015
Provectus Biopharmaceuticals Signs Letter of Intent with Boehringer Ingelheim (China) to Collaborate in Bringing PV-10 to Market in China
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 22 Jun 2015
Vaxil's Lead Product ImMucin has Been Granted an Orphan Drug Designation by the FDA for the Treatment of Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 May 2015
Merck KGaA, Darmstadt, Germany, Receives FDA Fast Track Designation for Evofosfamide for the Treatment of Patients Living With Advanced Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 May 2015
GW Pharmaceuticals Initiates Phase 3 Pivotal Study of Epidiolex(R) (CBD) in Lennox-Gastaut Syndrome
Biopharmaceuticals Neurology

HSMN NewsFeed - 8 May 2015
Provectus Biopharmaceuticals Updates Market on Business Developments
Biopharmaceuticals Dermatology Oncology

HSMN NewsFeed - 1 May 2015
Advanced Inhalation Therapies Granted European Orphan Drug Designation for Nitric Oxide for the Treatment of Cystic Fibrosis
Biopharmaceuticals Regulatory

HSMN NewsFeed - 20 Apr 2015
Oasmia's Lead Cancer Product Paclical(R) Receives Market Approval in the Russian Federation
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 25 Mar 2015
VBL Therapeutics Reports Interim Topline Results From Phase 2 Clinical Trial of VB-111 in Recurrent Glioblastoma (rGBM)
Biopharmaceuticals Oncology

HSMN NewsFeed - 18 Mar 2015
Selten Pharma, Inc. Receives Orphan Drug Designation From U.S. FDA for the Treatment of Pulmonary Arterial Hypertension
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Feb 2015
Chiasma Announces Completion of $70 Million Series E Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 27 Feb 2015
FDA Advisory Committee Recommends Approval for Avedro�s Riboflavin Ophthalmic Solutions with UVA Irradiation for Corneal Collagen Cross-Linking to Treat Progressive Keratoconus and Corneal Ectasia
Biopharmaceuticals Ophthalmology 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 - 18 Feb 2015
aTyr Pharma Receives EMA Orphan Drug Designation for Resolaris(TM) in FSHD
Biopharmaceuticals Regulatory

HSMN NewsFeed - 12 Feb 2015
Pivotal Phase 3 Trial of Investigational Agent Lenvatinib in Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer Published in New England Journal of Medicine
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Jan 2015
Catalyst Pharmaceuticals Appoints David D. Muth, Executive Vice President, Chief Commercial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 18 Dec 2014
Scioderm, Inc. Closes $20 Million Series B Round of Financing
Biopharmaceuticals Dermatology Venture Capital

HSMN NewsFeed - 16 Dec 2014
Novartis gains FDA approval for Signifor(R) LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Dec 2014
Oncolytics Biotech(R) Inc. Announces Filing for Orphan Drug Designation with the U.S. FDA for Pancreatic and Ovarian Cancers
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Nov 2014
FDA Grants Orphan Drug Designation to Merrimack Pharmaceuticals' MM-141 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology 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 - 27 Oct 2014
Zogenix Acquires U.K.-Based Brabant Pharma
Biopharmaceuticals Neurology Mergers & Acquisitions

HSMN NewsFeed - 27 Oct 2014
Aeterna Zentaris Announces Formal Implementation of its Sales Force In Support of Selling ASCEND's EstroGel(R)
Biopharmaceuticals Distribution

HSMN NewsFeed - 23 Oct 2014
Raptor Pharmaceutical Announces Management Changes
Biopharmaceuticals Personnel

HSMN NewsFeed - 7 Oct 2014
Pinnacle Biologics, Inc., a subsidiary of Concordia Healthcare Corp., announces European site initiation of Phase 3 bile duct cancer trial using photodynamic therapy with PHOTOFRIN(R)
Biopharmaceuticals Oncology

HSMN NewsFeed - 16 Sep 2014
NovaBiotics Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for Lynovex(R) for the Treatment of Cystic Fibrosis
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Sep 2014
Catalyst Pharmaceuticals Appoints David D. Muth as Executive Vice President, Corporate Development
Biopharmaceuticals Personnel

HSMN NewsFeed - 5 Aug 2014
Aeterna Zentaris and ASCEND Therapeutics Sign Co-Promotion Agreement for U.S. Market
Biopharmaceuticals Distribution

HSMN NewsFeed - 5 Aug 2014
Genoa Pharmaceuticals Receives Orphan-Drug Designation for Pirfenidone in the Inhaled Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Biopharmaceuticals FDA

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 - 23 Jul 2014
FDA Approves Eagle Pharmaceuticals� Ryanodex(R) for the Treatment of Malignant Hyperthermia
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Jul 2014
Shire Enters Strategic Licensing and Collaboration Agreement With ArmaGen
Biopharmaceuticals Neurology Licensing

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 - 3 Jul 2014
Akashi Therapeutics Receives Fast Track Designation for HT-100 from FDA for the Treatment of Duchenne Muscular Dystrophy
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Jul 2014
Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Dravet Syndrome, a Rare Form of Epilepsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 13 Jun 2014
EntreMed Stockholders Approve Name Change To CASI Pharmaceuticals
Biopharmaceuticals

HSMN NewsFeed - 11 Jun 2014
Lilly Announces Top-Line Results Of Phase III Hepatocellular Carcinoma Trial
Biopharmaceuticals Oncology

HSMN NewsFeed - 6 Jun 2014
Immune Appoints Gad Berdugo to Board of Directors and Karin Hehenberger, M.D., Ph.D to Senior Vice President
Biopharmaceuticals Personnel

HSMN NewsFeed - 22 May 2014
Veloxis Receives Positive Opinion from CHMP for Envarsus(R) for Treatment of Both Kidney and Liver Transplant Patients
Biopharmaceuticals Regulatory

HSMN NewsFeed - 21 May 2014
Provectus Biopharmaceuticals Inc. Appoints Jacob M. Plotsker to Strategic Advisory Board
Biopharmaceuticals Personnel

HSMN NewsFeed - 16 May 2014
Proteon Therapeutics Announces $45 Million of Series D Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 9 May 2014
Prima BioMed's CVac(TM) Granted Fast Track Designation by FDA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 May 2014
Immune Pharmaceuticals Announces Phase 3 Development and Commercialization Strategy for AMIKET
Biopharmaceuticals

HSMN NewsFeed - 1 May 2014
Merrimack Pharmaceuticals Announces MM-398 Achieves Primary Endpoint of Overall Survival in Phase 3 Trial in Post-Gemcitabine Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 28 Apr 2014
GW Pharmaceuticals Announces That Sativex Receives Fast Track Designation From FDA in Cancer Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Apr 2014
Spectrum Pharmaceuticals� Pivotal Trial of Captisol-Enabled(TM) (Propylene Glycol-Free) Melphalan Meets Primary Endpoint
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Apr 2014
Heart Metabolics Limited Launched in Ireland with $20 Million Series A Financing
Biopharmaceuticals Cardiology Venture Capital

HSMN NewsFeed - 16 Apr 2014
OxThera AB Receives SEK 70 Million Financing to Continue its Key Clinical Programs
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 16 Apr 2014
Wilson Therapeutics Secures $40 Million Private Financing To Advance Late Stage Development Program For Wilson's Disease
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 2 Apr 2014
Immune CEO Announces New Operational Leadership Team
Biopharmaceuticals Personnel

HSMN NewsFeed - 1 Apr 2014
Amarantus Appoints Robert Farrell, J.D. as Chief Financial Officer
Biopharmaceuticals Diagnostics Personnel

HSMN NewsFeed - 28 Mar 2014
Catalyst Pharmaceutical Partners Expands Executive Leadership Team to Support the Commercialization of Firdapse(TM)
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 26 Mar 2014
FDA Approves Optiguide(R) DCYL700 Fiber Optic Diffuser Series Flexible Fiber
Devices FDA

HSMN NewsFeed - 25 Mar 2014
Exelixis Receives Approval for COMETRIQ(R) (Cabozantinib) in the European Union for Treatment of Progressive, Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 11 Mar 2014
Lumena Pharmaceuticals Raises $45 Million in Series B Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 28 Feb 2014
GW Pharmaceuticals Receives Orphan Drug Designation by FDA for Epidiolex(R) in the Treatment of Lennox-Gastaut Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Feb 2014
Sunesis Appoints Joseph I. DePinto as Chief Commercial Officer, Updates VALOR Timeline to Unblinding of Data
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 14 Jan 2014
Neuralstem Appoints Catherine Angell Sohn To Board Of Directors
Regenerative Medicine Neurology Personnel

HSMN NewsFeed - 7 Jan 2014
KaloBios Appoints Harry Lam, Ph.D. as Head of Manufacturing
Biopharmaceuticals Personnel

HSMN NewsFeed - 7 Jan 2014
Cempra, Inc. Names David Moore as Chief Commercial Officer to Manage Commercial Development and Launch of Solithromycin and Taksta(TM)
Biopharmaceuticals Personnel

HSMN NewsFeed - 3 Jan 2014
NPS Pharmaceuticals Receives Orphan Drug Designation for Natpara(R) in Europe
Biopharmaceuticals Regulatory

HSMN NewsFeed - 3 Jan 2014
RegeneRx Receives Orphan Drug Designation for Tβ4 in the Treatment of Neurotrophic Keratopathy
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 27 Dec 2013
European Medicines Agency (EMA) Accepts Otsuka's Marketing Authorisation Application (MAA) for Tolvaptan, an Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 24 Dec 2013
Concordia Healthcare Corp. Announces Acquisition Of Pinnacle Biologics, Inc.
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 24 Dec 2013
Veloxis Pharmaceuticals Envarsus(R) Granted Orphan Drug Status by U.S. Food and Drug Administration for Kidney Transplant Rejection Prophylaxis
Biopharmacecuticals FDA

HSMN NewsFeed - 20 Dec 2013
Cellceutix Files Orphan Drug Designation Application for Brilacidin for Oral Mucositis with US FDA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Dec 2013
America Stem Cell, Inc. Changes Its Name to Targazyme, Inc.
Biopharmaceuticals Regenerative Medicine Oncology

HSMN NewsFeed - 17 Dec 2013
Provectus Announces Name Change to Provectus Biopharmaceuticals, Inc. and Reincorporates in Delaware
Biopharmaceuticals Dermatology Oncology

HSMN NewsFeed - 13 Dec 2013
Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2b Frozen Shoulder Syndrome Study of Collagenase Clostridium Histolyticum
Biopharmaceuticals Orthopaedic

HSMN NewsFeed - 27 Nov 2013
CMC Contrast Granted Orphan Drug Designation by the FDA for its Liver Specific MRI Contrast Media CMC-001
Biopharmaceuticals Radiology FDA

HSMN NewsFeed - 22 Nov 2013
Threshold Pharmaceuticals Announces New Clinical Data on TH-302 and Avastin(R) (Bevacizumab) in Recurrent Glioblastoma Following Bevacizumab Failure
Biopharmaceuticals Oncology

HSMN NewsFeed - 18 Nov 2013
Kiadis Pharma Provides Positive Update on its Phase II Clinical Program with Blood Cancer Treatment ATIR(TM)
Biopharmaceuticals

HSMN NewsFeed - 11 Nov 2013
Shire to Acquire ViroPharma in Strategic Move to Strengthen Rare Disease Portfolio; Will Augment Already Strong Growth Prospects
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 31 Oct 2013
Stem Cell Therapeutics Receives U.S. Orphan Drug Designation for the Use of Tigecycline to Treat Acute Myeloid Leukemia
Regenerative Medicine Oncology FDA

HSMN NewsFeed - 29 Oct 2013
Pharmalink Receives US Orphan Drug Designation for Busulipo(TM), its Novel Oncology Product for Bone Marrow Transplantation
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Sep 2013
FDA Grants Orphan Drug Designation to Omeros' OMS824 for Huntington's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 26 Sep 2013
Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Sep 2013
FDA Grants Soligenix Orphan Drug Designation for SGX94 for Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Aug 2013
Grifols and Aradigm Corporation Complete the Closing of Worldwide Licensing Agreement to Develop and Commercialize Pulmaquin(R)
Biopharmaceuticals Drug Delivery Licensing

HSMN NewsFeed - 8 Aug 2013
FDA Grants Orphan Drug Status To Eisai's Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Jul 2013
Oncos Therapeutics Granted Orphan Drug Designation for CGTG-102 in Soft Tissue Sarcoma (STS) by FDA and EMA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Jul 2013
Edimer Secures $18M Series B Financing Led by New Enterprise Associates
Biopharmaceuticals Venture Capital Personnel

HSMN NewsFeed - 24 Jul 2013
Verastem Receives Orphan Drug Designation from the U.S. FDA for Defactinib in Mesothelioma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Mar 2013
Intercept Pharmaceuticals Appoints Daniel Regan as Chief Commercial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 14 Feb 2013
Verastem Files for Orphan Disease Status for VS-6063 in Mesothelioma
Biopharmaceuticals Oncology Regulatory FDA

HSMN NewsFeed - 29 Jan 2013
FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Jan 2013
Baxter Announces Agreement to Acquire Investigational Hemophilia Compound OBI-1 and Related Assets
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 24 Jan 2013
Acorda Therapeutics Announces Department of Defense Contract to Support Study of AC105 in Acute Spinal Cord Injury
Biopharmaceuticals Neurology Neurosurgery

HSMN NewsFeed - 3 Jan 2013
Gradalis, Inc. Closes $24 Million in Series B Financing to Advance Late-Stage Trials of FANG(TM) Personalized Cancer Vaccine
Biopharmaceuticals Oncology Venture Capital

HSMN NewsFeed - 2 Jan 2013
FDA Grants Soligenix Orphan Drug Designation for OrbeShield(TM) for Treatment after Exposure to a Radiological Disaster
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Dec 2012
FDA Approves Gattex(R) (teduglutide [rDNA Origin]) for Injection for the Treatment of Adult Short Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 11 Dec 2012
Diffusion Pharmaceuticals Receives FDA Orphan Designation for TSC, a First-in-Class Drug for the Treatment of Metastatic Brain Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Nov 2012
OXiGENE Announces OXi4503 Granted Orphan Designation for Treatment of Acute Myelogenous Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 20 Nov 2012
Ipsen and Inspiration Biopharmaceuticals Announce That OBI-1 Has Received Fast Track Designation from FDA for Acquired Hemophilia A
Biopharmaceuticals

HSMN NewsFeed - 8 Nov 2012
Albireo Has Been Granted Orphan Drug Designation for A4250 from the US FDA for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) and for Primary Biliary Cirrhosis (PBC)
Biopharmaceuticals

HSMN NewsFeed - 2 Nov 2012
uniQure's Glybera(R) First Gene Therapy Approved by European Commission
Biopharmaceuticals Regulatory

HSMN NewsFeed - 15 Oct 2012
Corcept Therapeutics Appoints Daniel M. Bradbury to Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 4 Oct 2012
BioSante Pharmaceuticals and ANI Pharmaceuticals Announce Merger Agreement
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 2 Oct 2012
Sunesis Pharmaceuticals Announces Management Promotions
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 2 Oct 2012
Cell Therapeutics OPAXIOTM Receives Orphan Drug Designation for Malignant Brain Cancer from FDA
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 Sep 2012
OxThera Raises Capital for Further Clinical Development of Oxabact(R)
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 4 Sep 2012
Revestive(R) (teduglutide) Receives European Marketing Authorization for the Treatment of Adults with Short Bowel Syndrome (SBS)
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 16 Aug 2012
Pharmalucence Announces FDA Approval and Orphan Drug Designation for Use of Sulfur Colloid Injection to Locate Lymph Nodes in Malignant Melanoma Patients
Biopharmaceuticals Diagnostics Oncology FDA

HSMN NewsFeed - 20 Jul 2012
First Gene Therapy in Western World Receives Positive Opinion in Europe from CHMP
Biopharmaceuticals Regulatory

HSMN NewsFeed - 25 Jun 2012
Baxter Announces FDA Approval for GAMMAGARD LIQUID as a Treatment for Multifocal Motor Neuropathy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 22 Jun 2012
Takeda Receives Positive CHMP Opinion for Teduglutide (Revestive(R)) for Patients with Short Bowel Syndrome
Biopharmaceuticals Gastroenterology Regulatory

HSMN NewsFeed - 13 Jun 2012
Stratatech�s StrataGraft(R) Skin Substitute Granted FDA Orphan Drug Designation
Devices Biopharmaceuticals Regenerative Medicine FDA

HSMN NewsFeed - 7 Jun 2012
OxThera Resumes Clinical Development of Hyperoxaluria Therapy
Biopharmaceuticals

HSMN NewsFeed - 22 May 2012
Talon Therapeutics Appoints Head of Commercial Operations and Planning
Biopharmaceuticals Drug Delivery Oncology Personnel

HSMN NewsFeed - 27 Apr 2012
Baxter Presents Efficacy and Safety Data Evaluating GAMMAGARD LIQUID for Multifocal Motor Neuropathy at AAN Annual Meeting
Biopharmaceuticals Neurology

HSMN NewsFeed - 19 Mar 2012
QLT Receives Orphan Drug Designation for Visudyne for Treatment of Central Serous Chorioretinopathy
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 12 Mar 2012
HemaQuest Pharmaceuticals Raises $13 Million in Series B Extension Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 15 Feb 2012
BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel�
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Feb 2012
Biogen Idec to Acquire Stromedix
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 18 Jan 2012
Ceptaris Therapeutics Receives EMA Orphan Drug Designation for Proprietary Mechlorethamine Gel
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 4 Jan 2012
Amsterdam Molecular Therapeutics Receives US Orphan Designation for Hemophilia B Gene Therapy
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Dec 2011
Avedro Announces Its Second FDA Orphan Drug Designation for Corneal Cross-linking
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 26 Oct 2011
Phase III Trial of Bayer's Investigational Compound Regorafenib (BAY 73-4506) in Metastatic Colorectal Cancer Meets Primary Endpoint of Improving Overall Survival
Biopharmaceuticals Oncology

HSMN NewsFeed - 26 Jul 2011
Diffusion Pharmaceuticals Receives FDA Orphan Status for TSC, a First-in-Class Drug for the Treatment of Primary Brain Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Jul 2011
BioSante Pharmaceuticals Announces Management Team Additions
Biopharmaceuticals Personnel

HSMN NewsFeed - 23 Jun 2011
Repligen Receives U.S. Fast Track Designation and European Orphan Medicinal Product Recommendation for RG3039 for Spinal Muscular Atrophy
Biopharmaceuticals

HSMN NewsFeed - 1 Jun 2011
FDA Grants Orphan Drug Designation for XTL's rHuEPO Treatment for Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 May 2011
Pfizer Announces Simultaneous Filing Of New Drug Applications For Crizotinib With U.S. Food And Drug Administration And Japanese Ministry Of Health, Labour And Welfare
Biopharmaceuticals Oncology

HSMN NewsFeed - 9 May 2011
FDA Grants Orphan Drug Designation for Mithridion's MCD-386CR to Treat Progressive Supranuclear Palsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 22 Mar 2011
Data Presented at AAAAI Annual Meeting Further Support the Safety and Efficacy of FIRAZYR(R) (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
Biopharmaceuticals

HSMN NewsFeed - 10 Mar 2011
ACT Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for hESC-Derived RPE Cells for Treatment of Stargardt's Disease
Regenerative Medicine Ophthalmology Regulatory

HSMN NewsFeed - 8 Mar 2011
Vanda Pharmaceuticals Receives Orphan Drug Designation in Europe for tasimelteon
Biopharmaceuticals Regulatory

HSMN NewsFeed - 3 Mar 2011
InterMune Receives European Union Approval for Esbriet(R) (pirfenidone)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 2 Mar 2011
Celsion Receives European Orphan Drug Designation for ThermoDox(R) to Treat Primary Liver Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 28 Feb 2011
Shire Files Complete Response to FDA's Not Approvable Letter for FIRAZYR(R) (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Feb 2011
Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for RHUCIN Biologics License Application
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Feb 2011
FDA Grants Full Approval for PROMACTA(R) (eltrombopag) for Treatment of Rare Blood Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Feb 2011
Sunesis Receives FDA Fast Track Designation for Vosaroxin in AML
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Feb 2011
BioSante Pharmaceuticals Reports Positive LibiGel(R) Safety Data in Phase III Program
Biopharmaceuticals

HSMN NewsFeed - 14 Feb 2011
ADVENTRX Signs Definitive Agreement to Acquire SynthRx Inc.
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 9 Feb 2011
Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS
Biopharmaceuticals Regenerative Medicine Neurology FDA

HSMN NewsFeed - 8 Feb 2011
Pervasis Receives FDA Fast Track Status for Vascugel(R) to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Biopharmaceuticals Interventional FDA

HSMN NewsFeed - 4 Feb 2011
FDA Grants Orphan Drug Designation to Bayer's Investigational Compound Regorafenib for the Treatment of Gastrointestinal Stromal Tumors
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Jan 2011
GATTEX(R) (teduglutide) Meets Primary Efficacy Endpoint in Phase 3 Pivotal Study in Patients with Adult Short Bowel Syndrome
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 10 Jan 2011
Exelixis� XL184 Granted Orphan Drug Designation and Assigned the Generic Name Cabozantinib
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Dec 2010
Swedish Orphan Biovitrum's Long-Lasting Hemophilia A Therapy Receives Orphan Drug Designation in the US
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Dec 2010
Corcept Therapeutics Announces Positive Phase 3 Study Results for CORLUX for the Treatment of Cushing's Syndrome
Biopharmaceuticals

HSMN NewsFeed - 17 Dec 2010
InterMune Announces Positive Opinion for Approval of Esbriet (Pirfenidone) in European Union
Biopharmaceuticals Regulatory

HSMN NewsFeed - 6 Dec 2010
NeuroVive Obtains U.S. Orphan Drug Designation for Traumatic Brain Injury
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 29 Nov 2010
Pfizer and Protalix BioTherapeutics Announce Submission of taliglucerase alfa for European Marketing Authorization for the Treatment of Gaucher Disease
Biopharmaceuticals Regulatory

HSMN NewsFeed - 9 Nov 2010
Semafore Pharmaceuticals Receives FDA Orphan Drug Designation for SF1126 in the Treatment of Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Nov 2010
Neogenix Oncology(R) Receives FDA Orphan Drug Status for Ensituximab (NPC-1C) for Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Sep 2010
Novartis Drug SOM230 is First Medical Therapy to Show Efficacy in a Phase III Trial in Cushing's Disease, a Debilitating Hormonal Disorder
Biopharmaceuticals

HSMN NewsFeed - 21 Sep 2010
Athersys Receives Orphan Drug Designation for MultiStem in Graft vs. Host Disease
Regenerative Medicine FDA

HSMN NewsFeed - 1 Sep 2010
Pfizer to Acquire FoldRx Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 18 Aug 2010
ImmunoGen, Inc. Announces Orphan Drug Designation Granted to Lorvotuzumab Mertansine for Treatment of Small-Cell Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 15 Jul 2010
Provectus Pharmaceuticals Reports Achieved Milestones for First Half of 2010, Recent Developments and Plans for the Remainder of the Year to Shareholders
Biopharmaceuticals Dermatology Oncology

HSMN NewsFeed - 1 Jul 2010
Cyclacel Pharmaceuticals Announces FDA Orphan Drug Designation for Sapacitabine in Both AML and MDS
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 Jun 2010
Celgene to Acquire Abraxis BioScience Inc.
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 24 Jun 2010
t2cure's Cellular Therapeutic Receives Orphan Drug Designation from FDA, EMA Recommendation for Buerger's Disease
Biopharmaceuticals Regenerative Medicine FDA Regulatory

HSMN NewsFeed - 8 Jun 2010
New ABRAXANE(R) Data Demonstrates Potential in Patients with Advanced and Malignant Melanoma, Among the Toughest Cancers to Treat
Biopharmaceuticals Oncology

HSMN NewsFeed - 24 May 2010
Repligen Receives Orphan Drug Designation from the FDA for RG2833 for Friedreich's Ataxia
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 18 May 2010
Dr. Henry A. McKinnell Jr., Former Pfizer CEO, Joins Emmaus Medical, Inc. Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 12 May 2010
Pfizer Enters Into Agreement With Ergonex Pharma to Acquire Investigational Treatment for Pulmonary Arterial Hypertension
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 16 Apr 2010
Alexion's Soliris(R) (Eculizumab) Receives Marketing Approval in Japan for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 24 Mar 2010
FDA Approves XIFAXAN(R) 550 MG Tablets for Reduction in Risk of Overt Hepatic Encephalopathy (HE) Recurrence
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2010
FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 10 Mar 2010
Cytokinetics Announces Orphan Drug Designation Granted to CK-2017357 for the Treatment of Amyotrophic Lateral Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 2 Mar 2010
InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
Biopharmaceuticals Regulatory

HSMN NewsFeed - 1 Mar 2010
AEterna Zentaris Receives Positive Opinion for Orphan Medicinal Product Designation for Perifosine for the Treatment of Multiple Myeloma from the Committee for Orphan Medicinal Products of the European Medicines Agency
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 Feb 2010
FDA Advisory Committee Recommends Approval Of XIFAXAN(R) (rifaximin) Tablets, 550 Mg for Maintenance of Remission of Hepatic Encephalopathy
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Feb 2010
FDA Grants Orphan Drug Status for Quark's QPI-1002 for the Prophylaxis of Delayed Graft Function in Kidney Transplant Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Feb 2010
EntreMed Receives Orphan Drug Designation for ENMD-2076 in Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 10 Feb 2010
Elbit Imaging Announces Data Monitoring Committee Recommends Continuation of Phase III Study of StemEx(R), a Cord Blood Stem Cell Product, for Leukemia and Lymphoma
Regenerative Medicine Oncology

HSMN NewsFeed - 10 Feb 2010
Data Monitoring Committee Recommends Continuation of Celsion's Phase III ThermoDox(R) Study for Primary Liver Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 1 Feb 2010
Pervasis Therapeutics Receives FDA Clearance for Pivotal Phase 3 Trial of Vascugel(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Jan 2010
EpiCept Receives Orphan Drug Designation for EpiCept NP-1 in U.S.
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Jan 2010
ViroPharma Expands Global Licensing, Commercialization and Development Rights for Cinryze(TM) (C1 esterase inhibitor [human])
Biopharmaceuticals Licensing

HSMN NewsFeed - 5 Jan 2010
Corcept Therapeutics Announces Four Anticipated Milestones for 2010
Biopharmaceuticals

HSMN NewsFeed - 21 Dec 2009
California Stem Cell, Inc Closes Series B Financing Round
Regenerative Medicine Venture Capital

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