Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program
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- Category: Bayer
Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news follows asundexian's first U.S. FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022.
Bayer opens first Co.Lab Life science incubator in Cambridge
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- Category: Bayer
Bayer AG announced the inauguration of its new life science incubator dubbed "Co.Lab Cambridge" located in Kendall Square in Cambridge, U.S.. Bayer's Co.Lab Cambridge is specifically designed to support cutting-edge cell and gene therapies (CGT) entrepreneurs with access to Bayer's enterprise wide expertise in addition to state-of-the art laboratory and office space.
Roche launches Institute of Human Biology to accelerate breakthroughs in R&D by unlocking the potential of human model systems
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the launch of the Institute of Human Biology (IHB) focussing on advancing research in the field of human model systems such as organoids. Leveraging human model systems, the institute aims to accelerate drug discovery and development by improving the understanding of how organs function and how diseases develop.
U.S. FDA approves PREVNAR 20®, Pfizer's 20-valent pneumococcal conjugate vaccine for infants and children
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®(20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.
GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) and BELLUS Health Inc. (TSX/NASDAQ: BLU) announced that they have entered into an agreement under which GSK will acquire BELLUS, a Canada-based, late-stage biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC) for US$14.75 per share of common stock in cash representing an approximate total equity value of US$2.0 billion (£1.6 billion).
Update to contractual arrangements between AstraZeneca, Swedish Orphan Biovitrum AB and Sanofi
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- Category: AstraZeneca
AstraZeneca, Swedish Orphan Biovitrum AB (publ) (Sobi) and Sanofi have updated and simplified their contractual arrangements relating to the development and commercialisation of nirsevimab in the US. Given the upcoming launch of nirsevimab in the US and other markets, simplification of the prior arrangements clarifies the roles and responsibilities of relevant parties.
FDA accepts Pfizer's Supplemental New Drug Applications for BRAFTOVI + MEKTOVI
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
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