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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 will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.
This week, researchers delivered insights and breakthroughs in regenerative medicine, Long COVID, immuno-oncology and inflammatory diseases.
Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.
One-year data indicates Biogen’s tofersen for SOD1-ALS, slows the decline of the disease through the lowering of SOD1 protein and neurofilament levels.
AstraZeneca has decided to drop the hypercholesterolemia candidate AZD8233 through to Phase III, despite meeting its Phase IIb primary efficacy endpoint, its partner Ionis announced Friday.
The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.
Advances in immuno-oncology and adaptive cell therapy that began about a decade ago are enabling fresh, biology-driven approaches to bring therapeutic cancer vaccines closer to fruition.
Seven biopharma companies are under new leadership. This week’s Movers & Shakers highlights these new chief executive officers who aim to guide their companies into the future.
Novartis outlined how its transformation to a pure-play innovative medicines company is nearly completed during a “Meet the Management” event in Switzerland.
The 7th Annual CAR-TCR Summit is ongoing in Boston, with more than 1,000 experts in CAR and TCR technologies attending. Here’s a look at some of the latest research and data being presented.