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Healthcare News Roundup: Biopharmaceuticals

 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 - 17 Aug 2018
FDA Approves EYLEA(R) (aflibercept) Injection sBLA in Wet Age-related Macular Degeneration
Biopharmaceuticals Ophthalmology 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 - 16 Aug 2018
CBT Pharmaceuticals Announces New Leadership Structure to Drive Global Expansion
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 16 Aug 2018
Grifols Achieves Key Milestone with FDA Approval of the New Consolidated Manufacturing Facility (CMF) for Production of Recombinant Proteins
Biopharmaceuticals Diagnostics FDA
 HSMN NewsFeed - 16 Aug 2018
Synthorx Appoints Immuno-Oncology Veteran Joseph Leveque, M.D., as Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 15 Aug 2018
IGM Biosciences Appoints Julie Hambleton, M.D., to Board of Directors
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 15 Aug 2018
Endo Lifts Temporary Stay of FDA Litigation Following the Launch of a Bulk-Compounded Vasopressin Product by a Section 503B Outsourcing Facility
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 14 Aug 2018
Sigilon Therapeutics Announces Leadership Transition and Appoints Rare Disease Pioneer Rogerio Vivaldi, M.D., as Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 14 Aug 2018
Actavalon Announces Appointments of Dr. John Hood to Its Board of Directors
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 14 Aug 2018
BiondVax Receives Second €6M Tranche Disbursement From the European Investment Bank (EIB)
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 13 Aug 2018
Cumberland Pharmaceuticals Appoints New Senior Executive
Biopharmaceuticals Personnel
 HSMN NewsFeed - 13 Aug 2018
Clinical Benefits of TPX-100 in Knee Osteoarthritis Patients are Associated with Improvements in Knee Cartilage Structure Modification
Biopharmaceuticals Regenerative Medicine Orthopaedic
 HSMN NewsFeed - 13 Aug 2018
Regeneron Provides Regulatory Update on EYLEA(R) (aflibercept) Injection sBLA in Wet Age-Related Macular Degeneration
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 13 Aug 2018
New Analysis Identifies Patient Populations With Cancer-associated VTE Who Could Benefit From Treatment With Oral, Once-daily LIXIANA(R) (edoxaban)
Biopharmaceuticals
 HSMN NewsFeed - 10 Aug 2018
Nuvo Pharmaceuticals(TM) Announces Letter of Intent to Acquire Commercial Products and Infrastructure from Aralez Pharmaceuticals
Biopharmaceuticals Acquisitions
 HSMN NewsFeed - 9 Aug 2018
Athenex Pharmaceutical Division Receives FDA Clearance to Import Potassium Chloride Injection Concentrate to Address U.S. Drug Shortage
Biopharmaceuticals 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 - 9 Aug 2018
Perrigo Expands OTC Growth Strategy With Rx-To-OTC Switch Licensing For Nasonex(R)
Biopharmaceuticals Licensing
 HSMN NewsFeed - 9 Aug 2018
Perrigo Announces Plan To Separate Prescription Pharmaceuticals Business
Biopharmaceuticals Generics Mergers & Acquisitions
 HSMN NewsFeed - 8 Aug 2018
Statement from Mylan's Board of Directors
Biopharmaceuticals
 HSMN NewsFeed - 8 Aug 2018
SQZ Biotech Completes Oversubscribed $72 Million Series C Financing
Biopharmaceuticals Venture Capital Personnel
 HSMN NewsFeed - 8 Aug 2018
Allergan Appoints Neurobiology Expert Michael E. Greenberg, PhD to its Board of Directors as Part of Active Board Refreshment Process
Biopharmaceuticals Ophthalmology Dermatology Personnel
 HSMN NewsFeed - 8 Aug 2018
Rockwell Medical Appoints New Chief Executive Officer
Biopharmaceuticals Personnel
 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
Apexigen Raises $73 Million In Series B And Series C Financings
Biopharmaceuticals Oncology Venture Capital Personnel
 HSMN NewsFeed - 8 Aug 2018
United Therapeutics Announces FREEDOM-EV Study Of Orenitram Meets Primary Endpoint
Biopharmaceuticals
 HSMN NewsFeed - 7 Aug 2018
Infinity Pharmaceuticals Appoints Samuel Agresta, M.D., M.P.H. as Chief Medical Officer
Biopharmaceuticals Oncology Personnel
 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 - 6 Aug 2018
CureGenetics raises $17 million in Series A Financing
Biopharmaceuticals Diagnostics Personnel
 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 - 6 Aug 2018
AOBiome Therapeutics Announces the Expansion of its Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 6 Aug 2018
US WorldMeds and Salix Announce U.S. Launch of LUCEMYRA(TM) (lofexidine) 0.18 Mg Tablets
Biopharmaceuticals Product Launch
 HSMN NewsFeed - 2 Aug 2018
Endo Announces Appointment of Laure Park as Senior Vice President, Investor Relations and Corporate Affairs
Biopharmaceuticals Personnel
 HSMN NewsFeed - 1 Aug 2018
IGM Biosciences Appoints Daniel S. Chen, M.D., Ph.D., as Chief Medical Officer; Names William Strohl, Ph.D., to Board of Directors
Biopharmaceuticals Oncology Personnel
 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 - 1 Aug 2018
Oncorus(R), Inc., Names Industry Veteran Ted Ashburn as new President and CEO
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 30 Jul 2018
Tenaya Therapeutics Appoints Faraz Ali as Chief Executive Officer
Biopharmaceuticals Cardiology Personnel
 HSMN NewsFeed - 30 Jul 2018
Daiichi Sankyo Enters Worldwide Licensing Agreement with Glycotope for Gatipotuzumab Antibody Drug Conjugate
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 30 Jul 2018
Enzyvant Expands Leadership Team with Appointments of Andrew Dawson and Alex Tracy
Biopharmaceuticals Personnel
 HSMN NewsFeed - 30 Jul 2018
OncoSec Appoints Robert W. Ashworth, Ph.D. as Vice President, Regulatory
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 27 Jul 2018
PharmaMar Reaches an Agreement With Impilo Pharma, a Part of Immedica Group, for the Promotion and Distribution of Yondelis(R) in the Nordic Countries and Eastern Europe
Biopharmaceuticals Oncology Distribution
 HSMN NewsFeed - 27 Jul 2018
Endo Begins Shipment of Authorized Generic Version of INVANZ(R) (ertapenem for injection) in the United States
Biopharmaceuticals Generics Product Launch
 HSMN NewsFeed - 27 Jul 2018
Accord Healthcare’s (Intas) Pelgraz(R) (pegfilgrastim) Given Green Light by CHMP
Biopharmaceuticals Generics Oncology Regulatory
 HSMN NewsFeed - 26 Jul 2018
Phase 3 Study Of Subcutaneous Pertuzumab And Trastuzumab Initiated Using Halozyme's ENHANZE(R) Technology
Biopharmaceuticals Oncology Drug Delivery
 HSMN NewsFeed - 25 Jul 2018
Torque Appoints James Mullen as Chairman of Board of Directors, Maykin Ho, PhD, as Strategic Advisor to the Board of Directors, and Mario Sznol, MD, to Scientific Advisory Board
Biopharmaceuticals Oncology Personnel
 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 - 24 Jul 2018
Sutro Biopharma Collaborates with Merck to Develop Therapeutics for Cancer and Autoimmune Disorders
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 24 Jul 2018
Soligenix Announces Appointment of Mark Pearson to its Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 24 Jul 2018
BioAtla Appoints Lawrence Fong, M.D. As Scientific Advisor
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 24 Jul 2018
Biohaven Receives FDA May Proceed Letter And Initiates Phase 2/3 Clinical Trial Of Trigriluzole (BHV-4157) In Alzheimer's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 23 Jul 2018
Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Jul 2018
Amneal Announces FDA Approval and Launch of Generic Potassium Chloride Oral Solution
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 23 Jul 2018
Lannett Announces Multiple Product Launches
Biopharmaceuticals Generics Product Launch
 HSMN NewsFeed - 23 Jul 2018
Sangamo Therapeutics to Acquire TxCell
Biopharmaceuticals Mergers & Acquisitions
 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 - 19 Jul 2018
BioPharmX Announces FDA Grant of CARC Waiver and Post-Hoc Analysis for BPX-01
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 19 Jul 2018
Genesis Drug Discovery & Development Appoints Olesia Buiakova, M.D., Ph.D., as Chief Scientific Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 18 Jul 2018
PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study
Biopharmaceuticals Surgery FDA
 HSMN NewsFeed - 17 Jul 2018
Spruce Biosciences Appoints David Moriarty, Ph.D., as Vice President of Development Operations
Biopharmaceuticals Endocrinology Personnel
 HSMN NewsFeed - 17 Jul 2018
HotSpot Therapeutics Completes $45 Million Series A Financing to Advance New Approach to Allosteric Drug Discovery
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 17 Jul 2018
Ascentage Pharma Raises $150 Million in Series C Financing
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 16 Jul 2018
MEI Pharma Promotes David M. Urso to Chief Operating Office
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 16 Jul 2018
Pliant Therapeutics Raises $62 Million in Series B Financing to Advance Therapies for Fibrotic Diseases
Biopharmaceuticals Venture Capital Personnel
 HSMN NewsFeed - 16 Jul 2018
enGene Appoints Veteran Life Sciences Executive Jason D. Hanson as Chief Executive Officer and President
Biopharmaceuticals Drug Delivery Personnel
 HSMN NewsFeed - 16 Jul 2018
NeuroTrauma Sciences and Henry Ford Health System Announce Research and License Agreements to Develop Exosome Technology for Neurological Injury
Biopharmaceuticals Neurology Licensing
 HSMN NewsFeed - 16 Jul 2018
Aurobindo Signs a Definitive Agreement to Acquire Apotex' Businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium
Biopharmaceuticals Generics Mergers & Acquisitions
 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 - 13 Jul 2018
Modus Therapeutics Completes a SEK 140 Million Financing led by HealthCap
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 13 Jul 2018
Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY(TM) (romosozumab) To The US FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Jul 2018
Gala Therapeutics Receives FDA IDE Approval for a US Early Feasibility Study of Its RheOx(TM) System to Treat Chronic Bronchitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Jul 2018
Synthorx Expands Leadership Team with Three Key Hires
Biopharmaceuticals Personnel
 HSMN NewsFeed - 11 Jul 2018
FDA Accepts Biologics License Application For Subcutaneous Formulation Of Herceptin
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 10 Jul 2018
Sandoz Inc. and its affiliate, Novartis Pharmaceuticals Corporation, voluntarily recall select blister packages of products in the U.S. due to packaging requirements for child resistance
Biopharmaceuticals Product Recall
 HSMN NewsFeed - 10 Jul 2018
Hon. Robert Hormats Joins Grace Therapeutics' Board of Directors
Biopharmaceuticals Neurology Personnel
 HSMN NewsFeed - 9 Jul 2018
Mylan Adds to Central Nervous System Portfolio With Launch of Generic Exelon(R) Patch
Biopharmaceuticals Neurology Generics Product Launch
 HSMN NewsFeed - 9 Jul 2018
Results of Phase III (PIX306) Trial Evaluating Progression-Free Survival of PIXUVRI(R) (pixantrone) Combined with Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma
Biopharmaceuticals Oncology
 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 - 9 Jul 2018
Polaris Announces Drs. James Allison and Padmanee Sharma Joining its Scientific Advisory Board
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 6 Jul 2018
BioArctic Announces Positive Topline Results of BAN2401 Phase 2b at 18 Months in Early Alzheimer's Disease
Biopharmaceuticals Neurology
 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 - 5 Jul 2018
Adlai Nortye Raises $53M in Series B
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 4 Jul 2018
Theratechnologies Submits Novel Single-Vial Formulation of EGRIFTA(R) (Tesamorelin for Injection) for FDA Approval
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 3 Jul 2018
Sorrento Acquires the Sofusa(TM) Lymphatic Delivery Platform for Immune-Oncology (I-O) Antibody Therapeutics
Biopharmaceuticals Oncology Drug Delivery Acquisitions
 HSMN NewsFeed - 3 Jul 2018
Juniper Pharmaceuticals Signs Definitive Agreement to be Acquired by Catalent, Inc. for $11.50 Per Share in Cash
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 3 Jul 2018
MabVax Therapeutics Grants Exclusive Sublicense to Y-mAbs Therapeutics for Patented Neuroblastoma Vaccine
Biopharmaceuticals Oncology Licensing
 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 - 29 Jun 2018
Ultragenyx Announces Positive CHMP Opinion for Mepsevii(TM) (vestronidase alfa) For the Treatment of Mucopolysaccharidosis VII
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 29 Jun 2018
Amneal Announces Favorable Ruling Regarding Patent Validity for Zomig(R) (zolmitriptan) Nasal Spray
Biopharmaceuticals Generics Litigation
 HSMN NewsFeed - 29 Jun 2018
Intec Pharma Appoints William Bradley Hayes to Board of Directors
Biopharmaceuticals Drug Delivery Personnel
 HSMN NewsFeed - 29 Jun 2018
I-Mab Successfully Raised USD 220 Million in Series C Funding
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 28 Jun 2018
Avella Selected by Array BioPharma Inc. to distribute BRAFTOVI(TM) (encorafenib) and MEKTOVI(R) (binimetinib)
Biopharmaceuticals Oncology Distribution
 HSMN NewsFeed - 28 Jun 2018
Corporate Biotech Executive Mark Germain Joins BiondVax's Board of Directors
Biopharmaceuticals Personnel
 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 - 28 Jun 2018
Lupin and Mylan Partner to Commercialize Enbrel(R) (Etanercept) Biosimilar
Biopharmaceuticals Generics
 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 - 27 Jun 2018
Adicet Bio appoints Stewart Abbot, Ph.D. as Chief Scientific Officer
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 27 Jun 2018
ANI Pharmaceuticals Announces Launch of Cholestyramine for Oral Suspension USP
Biopharmaceuticals Product Launch
 HSMN NewsFeed - 27 Jun 2018
AcelRx receives European Commission approval for DZUVEO(TM)
Biopharmaceuticals Drug Delivery Regulatory
 HSMN NewsFeed - 27 Jun 2018
Carisma Therapeutics Announces a $53 Million Series A Financing to Develop Novel CAR Macrophage Cellular Immunotherapy
Biopharmaceuticals Venture Capital
 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 - 26 Jun 2018
AbbVie and Calico Announce Extension of Groundbreaking Collaboration
Biopharmaceuticals Neurology Oncology
 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 - 25 Jun 2018
Cronos Group Inc. Announces Exclusive Distribution Agreement with Delfarma in Poland
Biopharmaceuticals Distribution
 HSMN NewsFeed - 25 Jun 2018
Akero Therapeutics Closes $65 Million Series A Financing to Advance New Treatments for Serious Metabolic Diseases
Biopharmaceuticals Licensing Venture Capital
 HSMN NewsFeed - 25 Jun 2018
DelMar Pharmaceuticals Appoints World-Renowned Molecular Biologist Dr. Napoleone Ferrara to Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 25 Jun 2018
Nordic Nanovector Appoints Eduardo Bravo as Chief Executive Officer
Biopharmaceuticals Oncology Personnel
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