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While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”
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Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Merck’s acquisition of Terns Pharmaceuticals follows other big-ticket purchases, including of Verona Pharma and Cidara Therapeutics, as the pharma prepares for the impending expiration of its blockbuster’s patents.
Missing one of its co-primary endpoints could make it difficult for Karyopharm Therapeutics to score conventional approval for Xpovio in myelofibrosis, according to Jefferies analysts.
While RA Capital Management has yet to commit to a merger plan, it noted that its new blank-check company, Research Alliance III, could target companies abroad, including those from China.
Gilead continues its dealmaking spree in the sizzling hot space of I&I as Johnson & Johnson, along with partner Protagonist, notched an FDA approval for a new psoriasis drug. Plus, Aurinia Pharmaceuticals gets a new C-suite, FDA releases draft guidance on non-animal models and the CDC’s vaccine advisory committee is not being disbanded after all.
Overall, the top 16 largest pharmaceutical companies spent $159 billion on research and development in 2025, compared to $165 billion the year prior. Here’s where all that cash went at companies like Johnson & Johnson, Amgen and Pfizer.
Trace Neuroscience, a member of BioSpace’s NextGen Class of 2026, has learned from the success of Biogen’s Qalsody and aims to bring more treatment options to the ALS community.
While ersodetug missed the Phase 3 primary endpoint of a reduction in hypoglycemia events, Rezolute argued that this goal was confounded in part by behavioral factors. The FDA acknowledged the validity of this argument.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
Like its pharma peers, Novartis is pouring money into Chinese operations, including expansions and upgrades at an existing manufacturing facility.
Aardvark Therapeutics’ obesity asset is based on its lead molecule, which in February was linked to reversible heart safety signals in a healthy volunteer study.