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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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Ginkgo Bioworks opened its wallet Tuesday and snapped up Circularis and Altar to strengthen its cell and gene therapy programs and bolster its manufacturing capabilities.
Bristol Myers Squibb entered two separate research collaboration and licensing deals, one with San Francisco-based SyntheX and the second with London’s Autolus Therapeutics.
Early data from the Phase III TALAPRO-2 study showed Talzenna, Pfizer’s oral PARP inhibitor, met its primary endpoint in metastatic castration-resistant prostate cancer patients.
KalVista Pharmaceuticals announced Tuesday that life-threatening safety concerns prompted it to shut down a mid-stage clinical trial for hereditary angioedema.
With ambitions to enter the clinic in the first half of 2023, Keir Loiacono, esq., aims to double down on BlueSphere’s strengths rather than make any major course corrections.
Synlogic, Senti Biosciences and Novome are pioneering the field of synthetic biotics, which is so new there are only a handful of scientific articles using either that term or ‘engineered living therapeutics.
Scandion Oncology, Edesa, Clovis, Lexicon and Cytokinetics share a string of positive news from their clinical trials on heart failure, cancer, COVID-19 and ARDS.
Incyte Corporation will acquire privately-held Villaris and AmplifyBio will acquire PACT Pharma, while Estrella will gain a spot on the Nasdaq Exchange.
Clene’s gold nanocrystal asset CNM-Au8 failed to hit the primary endpoint in the HEALEY ALS trial, but strong survival signals at six months warrant additional exploration in treating ALS.
Intercept Pharmaceuticals’ Ocaliva failed to treat patients with compensated cirrhosis due to nonalcoholic steatohepatitis better than a placebo in a Phase III trial, the company announced Friday.