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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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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 ESMO conference is serving as a post-mortem on the trials that sunk the multi-billion-dollar partnership between Bristol-Myers Squibb and Nektar Therapeutics.
Biogen announced that its mid-stage monoclonal antibody litifilimab is showing promise in reducing joint pain related to systemic lupus erythematosus (SLE) lupus.
Sanofi and Regeneron presented results from the Phase III PRIME trial that showed Dupixent strongly improves itching and skin lesions in adult patients with prurigo nodularis.
FDA
Although it was a short week due to the Labor Day holiday, the FDA maintained a steady pace of business.
There are several approaches on the horizon in ALS, a space that is gaining momentum. BioSpace spoke with GeNeuro, NeuroSense and the Tisch MS Research Center about their progress.
Dermatology drugmaker Arcutis is acquiring Ducentis Biotherapeutics for $14 million in cash, $16 million in stock and milestones.
Homology Medicines and MiMedx both posted new CEOs. Other C-suite positions, including CFOs and CMOs were also filled this week.
A collaborative team of scientists formed The Long COVID Research Initiative to study and treat those battling the long-term effects of the virus, which include serious mental and physical symptoms.
A new report has shed light on some pharmaceutical companies’ attempts to circumvent federal anti-kickback statutes by profiting from large donations to patient assistance organizations.
SpringWorks, Eli Lilly, EMD Serono and Mirati released data ahead of the European Society of Medical Oncology (ESMO) 2022 Meeting in Paris.