Primary endpoint met in COMET-TAIL Phase III trial evaluating intramuscular administration of sotrovimab for early treatment of COVID-19
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- Category: GlaxoSmithKline
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Vir) (Nasdaq: VIR) announced headline data from the randomised, multi-centre, open-label COMET-TAIL Phase III trial, which achieved its primary endpoint, demonstrating intramuscular (IM) administration of sotrovimab was non-inferior to intravenous (IV) administration for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalised adults and adolescents (12 years of age and older).
Merck and Ridgeback's molnupiravir, an oral COVID-19 antiviral medicine, receives first authorization in the world
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- Category: Merck
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness.
Johnson & Johnson COVID-19 vaccine named one of Time's Best Inventions of 2021
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- Category: Johnson & Johnson
The editors of Time announced that the Johnson & Johnson COVID-19 vaccine has been selected as one of Time's Best Inventions of 2021.
The vaccine, for which Johnson & Johnson received Emergency Use Authorization from the U.S. Food and Drug Administration in February, is being recognized in the Medical Care category alongside two other COVID-19 vaccines.
CHMP recommends EU approval of Ronapreve to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the antibody combination, Ronapreve™ (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis).
Novartis to sell its Roche stake in a bilateral transaction to Roche
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- Category: Novartis
Novartis has agreed to sell 53.3 million (approximately 33%) Roche bearer shares in a bilateral transaction to Roche for a total consideration of USD 20.7 billion.
Vas Narasimhan, CEO of Novartis, said: "After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment.
Pfizer's novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of Phase 2/3 EPIC-HR study
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) today announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness.
Abbott launches new initiative to drive diversity in medical research and improve care among under-represented populations
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- Category: Abbott
Abbott (NYSE: ABT) today announced the launch of a new initiative designed to help create a more inclusive clinical trial ecosystem through new approaches to training, education, and improving the clinical research infrastructure within the U.S. This effort builds on Abbott's commitment of engaging populations who have historically been under-represented in medical research and will improve health by increasing access to innovative treatment options available within the trials process and increasing insights around how different groups respond to new therapies.
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