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Jeanne Marrazzo, former director of the National Institutes of Allergy and Infectious Disease, was formally terminated Thursday after months on administrative leave, after filing a whistleblower report.
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President Donald Trump loves a deal, but Most Favored Nation drug pricing isn’t a good one for anyone.
Novo Nordisk has plummeted back to Earth after a stunning rise driven by Ozempic and Wegovy. Can the storied Danish pharma recover?
After a slow 2024, the biotech shell company Concentra Biosciences is back, offering to buy four biotechs in the past month and seven so far this year.
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Positive results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival for patients with unresectable, Stage III epidermal growth factor receptor-mutated non-small cell lung cancer whose tumors have exon 19 deletions or exon 21 mutations, after chemoradiotherapy compared to placebo after CRT.
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Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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Like the first batch of appointees to the CDC’s vaccine advisory committee, several of the new panelists have documented histories of vaccine and COVID-19 skepticism.
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing.
Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if domestic production is disrupted.
Novartis and Monte Rosa first partnered in October 2024 for a molecular glue asset for immune-mediated and autoimmune diseases. This time, the pharma is putting $120 million down upfront for more of the biotech’s AI-discovered degraders.
CDER Director George Tidmarsh said on two separate events last week that he thought advisory committee meetings for specific drug applications were redundant, but then denied having said the agency would abandon them.
AstraZeneca in January also stopped its $610 million plans to construct a vaccine R&D and manufacturing site in the U.K.
After decades without much movement, a handful of new treatments for this rare autoimmune disease are now approved, and several companies, including argenx and Regeneron, have recently released promising late-stage trial results.
While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights into the therapeutic benefits of incretin therapies beyond weight loss.
On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda.
The settlement agreement will extend market exclusivity for AbbVie’s JAK inhibitor in the U.S. until 2037—providing pediatric exclusivity is granted.