New England Journal of Medicine publishes results from Phase 3 induction and maintenance programs evaluating upadacitinib (RINVOQ®) in Crohn's disease
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- Category: AbbVie
AbbVie (NYSE: ABBV) announced the New England Journal of Medicine (NEJM) published results from the pivotal Phase 3 clinical trials - U-EXCEL, U-EXCEED and U-ENDURE - evaluating upadacitinib (RINVOQ®) in adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to conventional therapy or a biologic agent.
Insilico Medicine receives IND approval for novel AI-designed USP1 inhibitor for cancer
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- Category: Business
Insilico Medicine ("Insilico"), a generative artificial intelligence (AI)-driven clinical stage drug discovery company, announced that the U.S. Food and Drug Administration (FDA) recently approved the initial investigational new drug (IND) application for ISM3091 for the treatment of patients with solid tumors. This is Insilico's first oncology program to advance to the clinical validation stage.
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.
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