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While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
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The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
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Read our takes on the biggest stories happening in the industry.
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.
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Sales of Johnson & Johnson’s oncology drugs jumped nearly 19% in the third quarter, driven by cancer treatment Darzalex which brought in more than $3 billion.
At 52 weeks of follow-up, more patients on Eli Lilly’s monoclonal antibody Omvoh demonstrated histologic response, suggesting better long-term outcomes than Johnson & Johnson’s blockbuster therapy Stelara.
With positive results for patients with the chronic skin condition, Jasper Therapeutics’ briquilimab is looking to take on Novartis and Genentech’s Xolair as well as Sanofi and Regeneron’s Dupixent.
Cycle’s second unsuccessful takeover bid comes on the heels of the FDA denying approval for Vanda’s tradipitant, which was being proposed for the treatment of gastroparesis.
BioSpace spoke to talent acquisition leaders about how they think artificial intelligence will shape the future of their function.
Analysts expect the partners’ first-mover advantage, clinical data and existing presence in lung disease to translate into significant sales, with GlobalData predicting Dupixent’s COPD revenues will top $6.5 billion within 10 years.
Evonik’s latest layoffs are tied to discontinuing production of keto acids in Hanau, Germany, by the end of next year. Earlier this year, news broke the company is also cutting up to 2,000 employees globally by 2026.
Under the deal, the Danish pharma will gain access to Longboard’s 5-HT2C receptor superagonist that is currently in late-stage development for seizures in various developmental and epileptic encephalopathies, including Dravet syndrome.
European CDMO Ardena will buy Catalent’s oral solids manufacturing facility in Somerset, N.J.
While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.