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FDA
Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
FEATURED STORIES
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
IPO
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Araris Biotech AG secured $24 million in financing to advance the development of its proprietary antibody-drug conjugate (ADC)-linker technology and drive its own ADC candidates into the clinic.
miRecule inked Tuesday a research partnership and licensing deal with Sanofi worth $30 million that will advance a best-in-class antibody-RNA conjugate to treat FSHD.
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.