Drug Development
During a Wednesday webinar, FDA Commissioner Robert Califf said the agency is working on “systemic” changes to its advisory committee process.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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Hemab Therapeutics announced the closing of an oversubscribed Series B round to bring new treatment options for lesser-known bleeding disorders.
If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
Moderna announced mixed interim results Thursday from a Phase III trial of mRNA seasonal flu vaccine candidate, mRNA-1010.
Pfizer and Valneva are dropping approximately half of enrolled participants in the Phase III VALOR study for their Lyme disease vaccine candidate, VLA15.
One-year data from a Phase II study of Newron’s schizophrenia candidate evenamide showed sustained efficacy and continued improvements in symptoms of psychosis and disease severity.
Seagen did not address rumors of a buyout from Merck during its fourth-quarter and full-year financial report. Instead, it focused on upcoming label expansions and its promising pipeline.
Talaris Therapeutics is cutting one-third of its workforce and dropping two clinical trials studying its lead candidate.
Biogen’s 2022 fourth-quarter and full-year report comes the day after an additional warning on the company’s first Alzheimer’s drug came to light.
Enveda’s primary R&D efforts will focus on inflammation, fibrosis and neurosensory biology within the GI, dermatology and pulmonary therapeutic areas.
The COVID-19 research collaboration between Vir Biotechnology and GSK has largely come to an end, as Vir announced Monday it would be going it alone or with other partners.