News
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
FEATURED STORIES
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Last month, the agency hired a new director for the Office of Therapeutic Products, but both leadership and support staff positions remain open.
As biopharma companies look to prove price setting provisions in the Inflation Reduction Act are unconstitutional, lawmakers unveil legislation to further reduce drug costs.
The new legislation could increase healthcare spending overall while reducing biopharma’s return on investment on biologic drugs.
Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
Following a handful of clinical failures and changes to its leadership, FibroGen is trying to chart a more positive path forward by focusing on four strategic areas.
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.