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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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Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.
GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.
One year after BridgeBio won accelerated approval for liver cancer drug Truseltiq (infigratinib), the company is pulling a planned Phase III program due to its partner’s decision to discontinue the drug.
Relmada Therapeutics’ RELIANCE III trial studying REL-1017 as a treatment for Major Depressive Disorder failed to hit the primary endpoint, the company reported Thursday.
Odyssey Therapeutics raised $168 million in a Series B financing round, which will be used to advance its portfolio of immunomodulators and oncology therapies.
The internet and “common wisdom” aren’t always right. Here are some of the top myths about three common conditions, and the truth from leading experts in their fields.
As part of a realignment, GreenLight Biosciences is cutting staff by about 25%, the company announced Wednesday.
Terray Therapeutics and Calico Life Sciences struck a research and development collaboration focused on the development of small-molecule therapeutics for age-related diseases.
Vividion Therapeutics and Tavros Therapeutics entered into a five-year collaboration agreement, valued at up to $930 million, to discover and develop four novel oncology targets.
Novartis’ gene therapy Zolgensma is again under a cloud of doubt after Nature Biotechnology retracted its 2010 article noting “issues” regarding data cited in a key figure in the report.