Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Bioinvent, Carmell, Eli Lilly, Emmaus, Iovance, Iveric, Kempharm, Novavax, Provention, Sanofi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apim, Blue Water, Iaso, Microvascular,Nona, Nordic Nanovector, Pfizer Replay, Sensei, Umoja, XNK.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Azura, Cocrystal, Editas, Evaxion, Immunic, Kinevant, Kiora, Organicell, Pfizer, Takeda, Visen, Vyne.
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 No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc.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.
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.
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