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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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Movers & Shakers: New C-Suites for Assembly Biosciences, Urica Therapeutics, BlueSphere Bio and More
Life sciences and biopharma companies added new CEOs, CMOs and CSOs to guide their companies into the future and oversee developmental programs.
Eli Lilly gained ground in the obesity market Thursday as the FDA granted Fast Track designation to Mounjaro (tirzepatide), an investigational drug for adults with obesity.
After an earlier stumble this year with its investigational major depressive disorder therapeutic, Eliem Therapeutics appears to be back on track with a planned Phase II study of ETX-155.
TauRx announced preliminary results from the Phase III study, showing HMTM, its potent inhibitor of tau aggregates, could slow Alzheimer’s disease progression or cognitive decline.
Red Tree Venture Capital closed a $272 million inaugural fund that will be used to support the development of therapeutics addressing unmet needs in oncology, neurology and immunology.
Provention Bio entered a co-promotion agreement with Sanofi ahead of the possible November approval of teplizumab. If approved, the drug would be the first approved to modify T1D.
Adocia, Allecra Therapeutics and Aldeyra Therapeutics announced promising results in Type I Diabetes, urinary tract infections and retinal diseases.
While Biogen and Eisai’s recent lecanemab data breathed new life into the anti-amyloid approach, experts say combination therapies will likely play a significant role in treating Alzheimer’s disease.
Nested Therapeutics, a precision oncology company targeting previously undruggable cancer targets, closed on a $90 million Series A financing, bringing total financing to $125 million since its inception in 2021.
GSK reported Wednesday its checkpoint inhibitor Jemperli yielded positive data in non-small cell lung cancer, moving the monoclonal antibody potentially closer to the market in this indication.