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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.
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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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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 Bay State, home to the busy bio-hub Genetown, is experiencing some growing pains. Companies like Biogen and Eisai (H3 Biomedicine) are reducing their headcount.
Innovent Biologics’ Phase II trial of mazdutide, a potential treatment for type 2 diabetes, showed the drug met its primary endpoint by successfully reducing HbA1c levels.
The FDA has approved Incyte’s Opzelura as the first and only at-home therapy for repigmentation in nonsegmental vitiligo.
The buyout comes on the heels of promising Phase I/II results from GTX-102, an antisense oligonucleotide candidate being developed to treat Angelman syndrome.
Five weeks after taking the reins as CEO of CRISPR-focused Editas Medicine, Gilmore O’Neill fulfilled his first task, appointing a new chief medical officer.
In what it is calling a strategic decision, Sesen Bio announced Monday that it has paused development activities of Vicineum, its lead asset, in the United States.
The delay is due, in part, to some internal Seagen actions, including a data readout for its bladder cancer drug Padcev, as well as a legal matter between Seagen and Daiichi Sankyo.
GSK, whose shares were up about 3.3% Monday, will likely use part of the 7 billion pounds it will generate via the Haleon spinoff to make acquisitions.
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In the latest in Nestlé’s efforts to establish a presence in the gastroenterology space, the company will pay over $40 million upfront to Enterome as part of a new partnership.