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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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Alaunos Therapeutics, Satsuma Pharmaceuticals, NeuroSense, Emyria and more reported updates in solid tumors, migraine, ALS and MDMA drug discovery.
Allogene Therapeutics’ French partner Servier has withdrawn all involvement in the development of Allogene’s anti-CD19 products, allowing Allogene to license its CD19 products outside the U.S.
Shares of Spero Therapeutics soared in premarket trading following GlaxoSmithKline’s announcement that it will license the company’s late-stage antibiotic asset, tebipenem HBr.
New data from Novo Nordisk’s Phase IIIa ONWARD 2 trial studying insulin icodec shows it is effective as a once-weekly treatment for Type 2 diabetes.
Rivus raised $132 million in a Series B financing round that will be used in developing HU6, a new drug class designed to treat cardio-metabolic disease by addressing obesity.
Carisma Therapeutics is merging with Sesen Bio to advance Carisma’s cell therapy platform - in particular, its chimeric antigen receptor macrophage (CAR-M) therapies.
Celltrion agreed Wednesday to jointly develop Abpro’s cancer molecule ABP-102 in a deal that could net as much as $1.75 billion. See inside for more cancer collaborations.
Novo Nordisk and Octagon Therapeutics announced that they forged a research collaboration focused on inflammatory diseases.
After enduring nine months of clinical holds, Merck announced that it is restarting the Phase III clinical program for islatravir, its candidate for people with HIV-1 infection.
A 3-judge panel questioned the legitimacy of Johnson & Johnson’s plan to form a subsidiary company with the purpose of absorbing legal liabilities from talc-related lawsuits.