FDA grants Priority Review to Amgen's tarlatamab application for advanced small cell lung cancer
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- Category: Amgen
Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.
Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
AstraZeneca to acquire Icosavax
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- Category: AstraZeneca
AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc. (NASDAQ: ICVX), a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform.
The proposed acquisition will build on AstraZeneca's expertise in respiratory syncytial virus (RSV), strengthening AstraZeneca's Vaccines & Immune Therapies late-stage pipeline with Icosavax's lead investigational vaccine candidate, IVX-A12. IVX-A12 is a potential first-in- class, Phase III-ready, combination protein VLP vaccine which targets both RSV and human metapneumovirus (hMPV),
Bayer and Salus Optima partner on AI-enabled healthy aging journey
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- Category: Bayer
Salus Optima, a leading provider in AI-enabled digital health and wellness solutions, and the Consumer Health division of Bayer have launched a strategic partnership to empower people on their healthy aging journey. The partnership elevates the shared aspiration of both companies to transform self-care by offering precision health solutions to enable consumers to better understand and make informed decisions about their own personal health and lifestyle choices.
Pfizer announces topline Phase 2b results of oral GLP-1R agonist, danuglipron, in adults with obesity
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced topline data from the Phase 2b clinical trial (NCT04707313) investigating its oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline.
Bayer and Hurdle launch precision health strategic partnership
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- Category: Bayer
Hurdle, a pioneer in diagnostic testing, and the Consumer Health division of Bayer have launched a strategic partnership to advance consumer innovations in the emerging area of healthy aging. The partnership is designed to enhance the companies' shared ambition to transform self-care through personalized solutions.
Bayer invests 130 million EUR in new production facility for innovative parenteral products
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- Category: Bayer
Bayer has added a brand new manufacturing facility to its global supply chain network. The new production plant was inaugurated today at the company's global pharmaceutical headquarters in Berlin, Germany. The facility features state-of-the-art technology, innovative production, and automated processes.
Pfizer and Astellas' XTANDI® approved by U.S. FDA in earlier prostate cancer treatment setting
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- Category: Pfizer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial.
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