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Ralph Abraham, a vocal vaccine skeptic who served at the agency for just three months, has stepped down due to “unforeseen family obligations,” according to the CDC.
FEATURED STORIES
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
THE LATEST
The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.
In a lawsuit filed Monday, Nektar Therapeutics accused Eli Lilly of scheming to ensure rezpegaldesleukin would not succeed after acquiring a competing medicine.
The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.
Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
A transformational moment in the treatment of depression, GSK takes first shot in a vaccine patent war with Pfizer, a Louisiana woman sues Novo Nordisk and Lilly, and companies face a steep COVID-19 cliff.
Partners Biogen and Sage Therapeutics had sought approval for the therapy in both postpartum depression and major depressive disorder, but the FDA rejected the application for the latter.
Thursday, Gilead Sciences reported lower second-quarter profit due to a drop in sales of the company’s Veklury antiviral and a $525 million legal settlement, while slightly raising its sales outlook for the year.
The market opportunity for pulmonary arterial hypertension drugs stretches well beyond the 500–1,000 Americans diagnosed with the disease each year—and biopharma is taking note.
For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.