U.S. FDA approves ABRYSVO™, Pfizer's vaccine for the prevention of respiratory syncytial virus (RSV) in older adults
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older.
Bayer launches unit to develop new precision health consumer products
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- Category: Bayer
The Consumer Health Division of Bayer has launched a business unit focused on developing new Precision Health products across its range of everyday health categories. Bayer will prioritize developing products that enable people to take greater control of their own personal health through digital solutions that facilitate more informed choices based on personal insights and novel delivery mechanisms.
Pfizer's PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA.
Insilico Medicine delivers preclinical candidate targeting ENPP1 for cancer immunotherapy and the treatment of rare disease using generative AI
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- Category: Business
Insilico Medicine (Insilico), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, announced that the company has nominated a potentially best-in-class preclinical candidate targeting ENPP1 for cancer immunotherapy and the potential treatment of Hypophosphatasia (HPP).
ENPP1 is an ecto-nucleotide pyrophosphatase that plays an important role in purinergic signaling that regulates immune, cardiovascular, neurological, and hematological system functions.
FDA Advisory Committee votes in support of approval for Pfizer's vaccine candidate to help prevent RSV in infants through maternal immunization
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316.
Thermo Fisher Scientific & Pfizer partner to expand localized access to next generation sequencing-based testing for cancer patients in international markets
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- Category: Pfizer
Pfizer and Thermo Fisher Scientific Inc. (NYSE: TMO) announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable.
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.
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- GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health
- Update to contractual arrangements between AstraZeneca, Swedish Orphan Biovitrum AB and Sanofi
- FDA accepts Pfizer's Supplemental New Drug Applications for BRAFTOVI + MEKTOVI
- Novo Nordisk Foundation to support crucial education of health professionals in India and East Africa with up to DKK 1bn (USD 140m)