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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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During the first quarter, 22 rounds of biopharma layoffs in California affected about 995 employees total, while 17 rounds in Massachusetts impacted around 410 people, based on BioSpace estimates. Meanwhile, competition for jobs in those states increased year over year, according to BioSpace data.
Looking for a biopharma job in Massachusetts? Check out the BioSpace list of nine companies hiring life sciences professionals like you.
In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale.
Despite making an unsolicited bid for gene therapy maker bluebird bio, Ayrmid failed to deliver a binding offer after weeks of due diligence. Bluebird’s board recommended that it go with Carlyle and SK Capital Partner’s original offer to take the company private for $30 million.
Analysts at Leerink agreed with Sanofi that, despite falling short of statistical significance in the Phase II TIDE-Asthma trial, amlitelimab warrants further development in this indication.
Playing both sides of trade war, pharma companies are asking for certain compensations for scientific innovation and a smoother regulatory framework.
Analysts are “cautiously optimistic” about Trump’s executive order, noting that changes to the IRA drug price negotiation program will still require Congressional action before being implemented.
The raise will go toward trialing the company’s lead drug for phosphomannomutase-2 congenital disorder of glycosylation, a rare disease that affects the entire body and produces a wide range of symptoms.
Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express concern about the FDA’s future; Pfizer’s obesity setback could be Viking’s gain; and BioSpace reveals the highest paid pharma CEOs.
Analysts have had to throw out their assumptions for the biopharma industry’s recovery heading into the first quarter earnings period given the ongoing tariff drama.