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.
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.
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- 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)
- Bayer Pharmaceuticals accelerates innovations for patients
- Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing; 100% achievement of all assessed milestones in children treated prior to SMA symptom onset