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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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The FDA’s Center for Drug Evaluation and Research issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena and will discuss the drug on Oct. 17-19.
Biogen may have found its CEO in Mathai Mammen - former head of research and development in pharmaceuticals at Johnson & Johnson.
Computational technology company Schrödinger announced Thursday it has forged a $425 million drug design collaboration with Eli Lilly.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
The FDA approved Alnylam’s Oxlumo for an expanded indication, rare disease PH1, with the label to include patients with the most severe kidney impairment.
Amgen opened a new research and development site in San Francisco Bay, while Enzo Biochem opened a 100,000 square foot laboratory and research facility in New York
Allogene Therapeutics is launching what it calls the first pivotal Phase II trial of an allogeneic CAR T product in the industry. The ALPHA2 trial will evaluate ALLO-501A in LBCL.
BioMarin Pharmaceuticals announced Friday it was shedding around 4% of its global workforce, or around 120 jobs, in an effort to improve its operational efficiency.
Evommune’s novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.
Surrozen announced Thursday it has partnered with Boehringer Ingelheim to research and develop a therapeutic for the treatment of retinal diseases.