AbbVie secures positive CHMP opinion for atogepant for the preventive treatment of adults with migraine
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- Category: AbbVie
AbbVie (NYSE: ABBV) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment spanning both episodic and chronic migraine in the European Union (EU).
Bayer extends partnership with Peking University to foster pharmaceutical innovation in China
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- Category: Bayer
Bayer and Peking University (PKU) will collaborate to foster the translation of basic pharmaceutical research into drug discovery and development, while accelerating scientific research on cutting-edge technologies across the pharmaceutical value chain.
The collaboration will focus on selected key areas of interests, such as oncology, cardiorenal, immunology, as well as cell and gene therapy.
FDA approves Pfizer's NGENLA™, a long-acting once-weekly treatment for pediatric growth hormone deficiency
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
Bayer's new pharmaceutical R&D strategy to accelerate breakthrough innovations
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This afternoon at 2 pm CET (8 am EDT), Bayer AG will host its Pharmaceuticals R&D Event 2023 for Investors. The company will present a deep dive on the innovation strategy in its four therapeutic core areas Oncology, Cardiovascular Diseases, Neurology & Rare Diseases and Immunology. The presentations will also include status updates on Bayer Pharmaceuticals' key assets in clinical and preclinical development as well as on its platform companies Asklepios BioPharmaceutical (AskBio), BlueRock Therapeutics (BlueRock) and Vividion Therapeutics (Vividion).
FDA accepts Pfizer's application for hemophilia B gene therapy fidanacogene elaparvovec
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA).
FDA approves Pfizer's LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
Pfizer's TALZENNA® in combination with XTANDI® receives U.S. FDA approval
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- Category: Pfizer
Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
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