Pfizer Inc. and Biontech SE have initiated a phase I study to evaluate the safety, tolerability and immunogenicity of BNT-162b4, a next-generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T-cell responses and potentially broaden protection against COVID-19.
An in-depth investigation of the underlying causes of pulmonary symptoms that in some cases persist for months following recovery from the acute stage of COVID-19 has found a distinctive proinflammatory signature in the plasma and airways of affected patients. The research could provide an explanation for the ongoing interstitial lung disease and fibrosis seen in patients who were hospitalized with severe COVID-19, and also point to neutrophils as a specific therapeutic target.
COVID-19 has vexed researchers, physicians and public health authorities since its emergence with an unexpectedly rapid rate of mutation. In addition to requiring constant adjustment of therapeutics and repeated vaccinations, the ever-changing virus has rapidly made scores of prognostic models irrelevant within months of development. Feinstein researchers appear to have met the challenge with an auto-updating model that predicts 28-day survival in patients hospitalized with COVID-19.
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
Novartis AG has described 3C-like proteinase (3CLpro) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
The number of biopharma deals with nonprofit or government entities has dwindled in recent months, while industry grants are climbing. Combined, however, a total of 936 bio/nonprofit deals and grants worth $11.17 billion is down by 37% in comparison with last year’s $17.8 billion and by 58.7% in comparison with 2020’s $27 billion. The volume also is down significantly by 16.8% from 2021 and by 33.4% from 2020.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Novocure, Trireme Medical.
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