Amgen, Cytokinetics and Servier announce continuation of GALACTIC-HF following planned interim analysis
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- Category: Amgen
Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and Servier today announced that the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned interim analysis, which included consideration of pre-specified criteria for futility and superiority.
AstraZeneca divests global rights to Movantik
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- Category: AstraZeneca
AstraZeneca has agreed to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma (RedHill). Movantik is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC).
Clover and GSK announce research collaboration to evaluate coronavirus (COVID-19) vaccine candidate with pandemic adjuvant system
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- Category: GlaxoSmithKline
Clover Biopharmaceuticals, a China based global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, announced today that it has entered into a research collaboration with GSK for its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer).
FDA approves GSK's Voltaren Arthritis Pain for over-the-counter use in the United States
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- Category: GlaxoSmithKline
GlaxoSmithKline (LSE/NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older).
FDA grants priority review to Roche's Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
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- Category: Novartis
Novartis announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC)(1).
Bayer and Nuvisan create new research unit in Berlin
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- Category: Bayer
Bayer AG today announced that it entered into a definitive agreement to transfer a large part of its Berlin-based small molecule research unit to Nuvisan, an international service provider for clinical studies, laboratory services and contract manufacturing with several sites and clinics in Germany and France.
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