TIVDAK® supplemental Biologics License Application accepted for Priority Review by FDA for patients with recurrent or metastatic cervical cancer
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson's disease meets primary endpoint
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- Category: Bayer
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced today the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson's disease (PD).
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with food allergy.
Pfizer declares first-quarter 2024 dividend
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that its board of directors declared an increase in the quarterly cash dividend on the company's common stock to $0.42 for the first-quarter 2024 dividend, payable March 1, 2024, to holders of the Common Stock of record at the close of business on January 26, 2024.
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.
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