Regulatory
Half of the net proceeds will go to Jazz; it remains unclear who will get the remaining sum. Jazz did not reveal the buyer of the voucher.
The past year saw manufacturing challenges pushed into the spotlight. BioSpace spoke to two executives who shared key issues facing those working in this area, from finding the right providers to dealing with regulatory uncertainty.
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.
AbbVie and Novartis strike billion-dollar pacts while attendees at the J.P. Morgan Healthcare Conference await that one big M&A deal and Merck teases limitless buying capacity; Eli Lilly readies for potential orforglipron launch while Novo Nordisk laments compounders; the IPO window cracks open; and the FDA concludes that GLP-1s do not pose a suicide risk.
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
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.
PRESS RELEASES