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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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Monday, Actinium Pharmaceuticals released promising results Monday from a Phase III trial studying its lead radiotherapy candidate, Iomab-B, for patients with relapsed or refractory AML.
The implications of the Inflation Reduction Act of 2022 (IRA) are beginning to show as Alnylam drops the Stargardt indication for vutrisiran and Sanofi’s CEO reassures investors.
ESSA confirmed that Janssen has stepped away from a prostate cancer collaboration due to “operational recruitment challenges.”
Platform technology company Replay, based in San Diego and London, has launched Eudora, a gene therapy company targeting genetic diseases of the retina.
CytoDyn withdrew its pending Biologics License Application for leronlimab in HIV, citing concerns involving the contract research organization managing its trials.
While reporting stellar third-quarter financials, AbbVie announced it was halting development of cedirogant and provided updates on Skyrizi, Rinvoq and Humira.
An investigator in the Phase III trial for Biogen and Eisai’s experimental Alzhiemer’s drug, lecanemab, is attributing a patient’s death to the treatment.
Sanofi will drop its IL-2 candidate, citing a lack of efficacy in the early stages of data collection, the company announced in its Q3 report Friday.
Mereo and Rubric Capital Management settled their proxy battle, entering a cooperation agreement. As a result, Rubric withdrew its notice for a General Meeting of shareholders.
During its third-quarter earnings report, BioMarin noted that the FDA planned to hold an advisory committee meeting to discuss the company’s gene therapy for hemophilia A.