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The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.
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With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
While prominent physicians can provide companies with valuable guidance during development, their perspective is limited when it comes to projecting how well or how readily a new product will be adopted. Here’s how to perform rigorous commercial diligence.
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Replimune is axing 144 employees at its Woburn headquarters and 80 at its Framingham manufacturing site. The cuts follow the FDA’s second rejection of the biotech’s advanced melanoma candidate.
With programs from Eisai and Hansoh Pharmaceutical in hand, Tortugas Neuroscience has emerged with hopes of delivering daily oral treatments to patients with central nervous system conditions.
Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
After entering the CAR T space in February, Eli Lilly is “jumping into in vivo CAR-T with both feet” with the acquisition of Kelonia Therapeutics and its gene delivery technology.
An investigational cocktail was tied to a 0% overall response rate in patients with gastroesophageal cancer, but developers Agenus and MiNK Therapeutics aren’t giving up on the program just yet.
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
While Novo Nordisk’s Wegovy pill reached more than 3,000 patients in its first week on the market, analysts at RBC Capital Markets said a direct comparison of the two figures could be misleading given the shorter data collection time for Foundayo.
Obesity-focused Kailera Therapeutics debuted on the Nasdaq Friday after raising a record $625 million, beating Moderna’s $600 million from 2018.
Right after the FDA flagged safety concerns for Eli Lilly’s newly approved obesity pill, the pharma posted diabetes data demonstrating a clean safety profile and revealed plans to seek approval in the indication.