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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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Bristol Myers Squibb and Johnson & Johnson will continue to test the asset in stroke and atrial fibrillation.
Bayer has let go of about 13,500 employees, including around 5,000 managers, since implementing a new operating model in early 2024. CEO Bill Anderson said in a recent earnings call that he expects a slower rate of headcount reduction moving forward.
“As the future chair I will attend to the interests of not only the Novo Nordisk Foundation but all shareholders of the company,” incoming chair and former Novo Nordisk CEO Lars Rebien Sørensen said at the meeting held Friday.
A day after Pfizer closed its hotly contested Metsera deal, Lundbeck has made an unsolicited offer to steal Avadel Pharmaceuticals away from Alkermes.
At $9.2 billion, the Cidara acquisition lands among the top 5 largest deals of the year.
Gilead’s investigational drug combo bic/len could help lower the pill burden in patients with virologically suppressed HIV who are on complex treatment regimens, according to BMO Capital Markets.
A BioNTech spokesperson downplayed the news, insisting that the two companies remain “close” and have a “strong collaboration.”
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Speaking at a conference this morning, Pfizer CEO Albert Bourla suggested that Metsera’s therapies could begin hitting the market in 2028.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.