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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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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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Roche first partnered with MediLink in January 2024, likewise for an antibody-drug conjugate for solid tumors.
Rampart Bioscience was working on a platform to deliver gene therapies without the need for viral vectors.
Pharmas will need to provide their latest stance on the Most Favored Nation drug pricing plans, while biotech finally gets a break after a few tough years.
Aside from the layoffs, InflaRx will deprioritize Gohibic, a COVID-19 antibody that was granted emergency use authorization in 2023. The therapy failed a late-stage trial in a rare skin disease last year.
Rumors of a Revolution buyout come as the industry gears up for one of its biggest trade conferences, where observers expect many such deals to be announced.
The DC-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for Hetlioz and promised to keep pushing for an approval.
Eli Lilly has expressed interest in participating in the IPO, with the regulatory filing revealing the obesity juggernaut’s plans to buy as much as $100 million worth of Aktis shares.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Maha Katabi, general partner at Sofinnova Investments and Andrew Lam, managing director, head of Biotech Private Equity at Ally Bridge Group, about how M &A dynamics, dealmaking and global partnerships are reshaping portfolio valuations and paths to growth in 2026.
A bevy of other companies also brought in money on Thursday, including Alveus Therapeutics, Diagonal Therapeutics, EpiBiologics, Beacon Therapeutics and Protege.
While venture capital funding dipped to a six-year low in 2025, it nevertheless remained above pre-pandemic levels for Massachusetts-based biopharma companies, according to MassBio.