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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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BioSpace caught up with Roland and Ben Buelow of Ancora, and Lightspeed Venture Partners’ Galym Imanbayev to talk about the AstraZeneca deal and the company’s unique business model.
Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.
Emory University’s Ken Thorpe told BioSpace that the average Medicaid spending on drugs approved under the accelerated pathway in relation to total Medicaid spending is.2%.
Mogrify and Astellas have forged a collaboration surrounding in vivo regenerative medicine approaches, while CardiNor inked a distribution deal with IBL-America.
Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.
Sarepta Therapeutics and its partner, Roche, presented promising functional data from several trials of its gene therapy for Duchenne muscular dystrophy.
A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.
Boehringer, Evotec and bioMérieux found Aurobac to combat antimicrobial resistance, Turnstone and Moffitt Expand TIL Collab, Skyhawk to gain potential $2B from Sanofi RNA splicing deal.
In patients stricken with ulcerative colitis for less than five years, AMT-101 was nearly three times more effective in inducing clinical remission than the placebo after eight weeks.
Findings from a study support the claim that the risk of developing a serious issue, such as respiratory or cardiac issues, is much more probable in the first 30 days following infection from COVID-19.