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Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
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Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer 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.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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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.
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.
The deals will help Lilly diversify its portfolio that is heavily weighted on the obesity juggernaut tirzepatide, marketed as Mounjaro for diabetes and Zepbound for weight loss.
The company announced a $350 million public offering on Monday shortly after revealing positive Phase II results for its investigational congenital adrenal hyperplasia drug, with hopes to one day compete with Neurocrine’s Crenessity.
The cardiovascular biotech was also named as one of BioSpace’s top startups to watch on Wednesday.
Though specific data for bepirovirsen remain under wraps, GSK plans to file for approval in the first quarter of 2026.
Jazz’s Ziihera and BeOne’s Tevimbra plus chemotherapy led to what Truist Securities dubbed one of the strongest overall survival signals ever reported in a type of gastroesophageal cancer.