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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.
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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.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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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 company said Thursday it has closed $200 million in Series B financing—on top of last year’s $200 million Series A haul—to help initiate a registrational Phase II study for its lead candidate UPB-101.
A total of nine U.S. cities stood out in terms of total NIH funding in 2022.
Astellas Pharma will license and further develop a gene therapy from Kate Therapeutics aimed at addressing XLMTM amid safety concerns about its own experimental XLMTM treatment.
A class-action lawsuit from thousands of third-party payers alleges that the companies broke racketeering laws to market their diabetes drug Actos, while not disclosing its bladder cancer risk.
In a 6-0 vote, the FDA’s advisory committee Friday affirmed that trial data confirmed the clinical benefit of Eisai and Biogen’s Leqembi (lecanemab) for the treatment of Alzheimer’s disease.
In a late-stage study of non-ambulatory patients with DMD on background corticosteroids, pamrevlumab failed to meet the primary endpoint for upper limb performance.
Promosome filed lawsuits Tuesday against Moderna and Pfizer/BioNTech, alleging that the vaccine developers used patent-protected mRNA technology without a license.
The Federal Trade Commission’s lawsuit takes an unusual strategy, according to legal experts, raising concerns and uncertainties in the biopharma industry.
While approved in non-small cell lung cancer, Keytruda failed to provide benefit for the TKI-resistant, EGFR-mutant subtype of the disease.
In a lawsuit filed Tuesday in federal district court, Merck claimed that the price negotiation program laid out in the Inflation Reduction Act violates the U.S. Constitution.