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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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Albireo Pharma reported dazzling Phase III ASSERT data of Bylvay for Alagille syndrome (ALGS). The company is headed to U.S. and European regulators with expectations of regulatory filings in Q1 of 2023.
With $50 million in backing from Apple Tree Partners, Ascidian Therapeutics launches Tuesday with technology that allows for the treatment of some diseases through rewriting of RNA.
One year after raising $500 million, Neumora Therapeutics secured an additional $112 million in a Series B financing round to support the advancement of its neuroscience portfolio.
Biotechnology Innovation Organization, the world’s largest science and public advocacy organization, announced Monday it has tapped Rachel King to serve as interim President and CEO.
Last week, rumors spread that PureTech Health was preparing to merge with Nektar Therapeutics. Now the deal, never officially announced, has been called off.
ImmunityBio is laying off 38 employees at its Dunkirk site in New York, Amneal will shutter a Long Island facility and Rigel culls 30 employees following wAIHA regulatory decision.
Data from an ongoing Phase III trial showed Sanofi/Regeneron’s Dupixent can induce histological disease remission in young EoE patients aged 1–11.
Ginkgo Bioworks partnered with Merck on engineered enzymes for use as biocatalysts for Merck’s active pharmaceutical ingredient (API) manufacturing programs.
Immatics announced plans to raise about $110 million in a common stock offering following the release of promising early-stage data that supports its ACTengine technology platform.
On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.