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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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In this episode of Denatured, you’ll listen to Sergey Jakimov, managing partner at LongeVC and Artem Trotsyuk, operating partner, US, LongeVC. We speak about how developers in the longevity space should stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly tackle age-related conditions.
Among biopharma professionals surveyed by BioSpace, respect remains higher for managers than for CEOs, and unhappiness with company leadership had nearly 1 in 7 people looking to walk away from their employer.
With thousands of companies and a $102 billion impact on the state’s economy, Indiana’s life sciences industry is making its mark. The president and CEO of the Indiana Life Sciences Association discusses the sector’s upside, challenges and where it’s headed in the future.
Besting Vertex Pharmaceuticals’ kidney disease asset wasn’t enough to impress Wall Street, which appears to be “getting hung up” with the broad population data in Maze Therapeutics’ trial, according to Mizuho.
This year’s catalysts in the space include a near-term FDA decision on Eli Lilly’s oral challenger to the new Wegovy pill. Looking further ahead, Novo Nordisk is expecting more clinical data for next-gen weight loss asset CagriSema, which recently lost a head-to-head battle with Lilly’s Zepbound.
The Belgian drugmaker plans to hire about 330 people at a facility that will use advanced manufacturing technologies including AI, robotics and automation to meet rising demand for key products. This will be UCB’s first biologics manufacturing facility in the U.S.
Looking for a biopharma job in New York? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
Merck’s acquisition of Terns Pharmaceuticals follows other big-ticket purchases, including of Verona Pharma and Cidara Therapeutics, as the pharma prepares for the impending expiration of its blockbuster’s patents.
Missing one of its co-primary endpoints could make it difficult for Karyopharm Therapeutics to score conventional approval for Xpovio in myelofibrosis, according to Jefferies analysts.
While RA Capital Management has yet to commit to a merger plan, it noted that its new blank-check company, Research Alliance III, could target companies abroad, including those from China.