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Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
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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.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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The biotech industry needs to stop waiting for a rebound. The pandemic changed everything, though not in the ways most people think.
If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.
Healthcare investor Kevin Tang and his allies now hold almost every leadership position at Aurinia Pharmaceuticals, the company at the heart of former CDER Director George Tidmarsh’s exit from the FDA.
The multivalent candidate, being developed by Pfizer and French partner Valneva under a 2020 pact, generated higher than 73% efficacy against the tick-borne disease in a Phase 3 trial—but failed to hit a predetermined confidence interval.
Kali Therapeutics’ T cell engager, for which Sanofi is initially paying $180 million, could potentially be developed for a range of B cell–driven autoimmune disorders.
The FDA detected 14 cases of vitamin B6 deficiency–linked seizures and two deaths in patients with Parkinson’s disease taking carbidopa/levodopa drugs. Both AbbVie and Novartis market levodopa-based products.
Earendil Labs’ AI-centered platform has produced more than 40 programs, including anti-inflammatory assets that have attracted a pair of partnership agreements with Sanofi.
Oryon Cell Therapies’ lead cell therapy is an autologous treatment designed to replace dopaminergic neurons in patients with Parkinson’s disease. Phase 1b/2a data showed that the asset can improve motor function and mobility in patients.
Longevity is a long-standing buzzword in life sciences, but it now has staying power. The smart trajectory is to stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly target specific, age-related diseases, according to two investors in a discussion with BioSpace.
Eli Lilly and Regeneron are leading the push to treat congenital deafness with gene therapies, seeking a piece of a potential billion-dollar market and banking on local delivery and the small amount of drug required to overcome key safety concerns.