Current Headlines

  1. Allergan Announces FDA Acceptance Of New Drug Application For Ubrogepant For The Acute Treatment Of Migraine
    3/11/2019

    Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults

  2. Eisai And Imbrium Therapeutics Announce U.S. FDA Filing Acceptance Of New Drug Application For Lemborexant For The Treatment Of Insomnia
    3/11/2019

    Eisai Co., Ltd. (CEO: Haruo Naito, "Eisai") and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P. (President and CEO: Craig Landau, MD), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. A Prescription Drug User Fee Act (PDUFA) date is set for December 27, 2019

  3. Genentech Submits Supplemental New Drug Application To FDA For Venclexta Plus Gazyva For Previously Untreated Chronic Lymphocytic Leukemia With Co-Existing Medical Conditions
    3/7/2019

    Genentech, a member of the Roche Group, recently announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions

  4. LifeMap Sciences And iCarbonX Research Shenzhen Announce Strategic Collaboration
    3/7/2019

    LifeMap Sciences (“LifeMap”), a subsidiary of AgeX Therapeutics, Inc., announced recently that it has entered into a collaboration with iCarbonX Research Shenzhen, enabling iCarbonX to leverage LifeMap’s GeneCards Suite platform in product prototype design and scientific research

  5. Roche Submits Supplemental New Drug Application To FDA For Venclexta Plus Gazyva For Previously Untreated Chronic Lymphocytic Leukaemia With Co-Existing Medical Conditions
    3/7/2019

    Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions

  6. Kezar Life Sciences Announces Initiation Of Clinical Study To Test A New Drug Product Formulation Of KZR-616
    3/6/2019

    Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, today announced the initiation of a Phase 1, randomized, double-blind, placebo controlled, single and multiple ascending dose trial to assess the safety, tolerability, pharmacokinetics and target inhibition of a simplified lyophilized formulation of KZR-616

  7. Ambrx And Beigene Announce Global Research And Development Collaboration To Develop Next-Generation Biologics
    3/6/2019

    Ambrx Inc., a clinical-stage biopharmaceutical company focused on the development of innovative protein therapeutics and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced a global research and development collaboration.

  8. Mitochon Pharmaceuticals Awarded Orphan Drug Designation
    3/5/2019

    Mitochon Pharmaceuticals recently announced that it was awarded Orphan Drug Designation by FDA for its mitochondrial targeted compound, MP-101 for treating Huntington’s Disease

  9. Cyrus Biotechnology Announces Release Of Antibody Structure Prediction Software For Biologics Drug Development And Discovery
    3/5/2019

    Cyrus Biotechnology, Inc., a Seattle-based biotech software company commercializing Rosetta, an advanced protein design platform, announced recently the release of a novel Antibody Structure Prediction Software tool as part of its Cyrus Bench platform

  10. Acceleron Receives FDA Orphan Drug Designation For ACE-083 In Charcot-Marie-Tooth Disease
    3/5/2019

    Acceleron Pharma Inc., a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, recently announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to ACE-083, the Company’s locally-acting “Myostatin+” muscle agent, for the treatment of patients with Charcot-Marie-Tooth disease (CMT)