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Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3 program.
The list honors 50 life sciences employers of choice. Employees at SERB Pharmaceuticals and CSL Behring share why their companies stand out.
Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.
The Phase 3 results help clarify the safety profile of Zealand and Boehringer Ingelheim’s survodutide, but analysts do not think the drug will find utility beyond patients with liver-related risk factors.
If approved, the oral GLP-1 would be Eli Lilly’s second marketed drug for obstructive sleep apnea after the GIP/GLP-1 injectable Zepbound secured the first approval in the space in December 2024.
Vir Biotechnology is targeting a mid-2027 regulatory submission for its monthly chronic hepatitis delta regimen, with head-to-head data against Gilead’s Hepcludex expected next quarter.
Compass Pathways has completed an FDA filing for COMP360, with an expected launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression last Monday.
A Phase 3 trial showed that Johnson & Johnson and Protagonist Therapeutics’ oral therapy Icotyde improved psoriatic arthritis symptoms but AbbVie’s injectable is likely to hold court based on higher efficacy, analysts say.
Full data from the Phase 3 HORIZON trial of Novartis’ pelacarsen failed to show any apparent benefit, leading analysts to further reduce the odds of success for Lp(a)-lowering competitors such as Amgen’s olpasiran.
Unnatural Products has risen from founder Joshua Schwochert’s garage to an acquisition deal, valued at up to $1.15 billion, to join argenx.