The US FDAhas proposed new bioequivalence guidelines for vancomycin oral capsules that require an in vivo study with clinical endpoints only when a generic's inactive ingredients are not substantially similar to those of the reference listed drug, Viropharma's Vancocin.
The US FDAhas proposed new bioequivalence guidelines for vancomycin oral capsules that require an in vivo study with clinical endpoints only when a generic's inactive ingredients are not substantially similar to those of the reference listed drug, Viropharma's Vancocin.
The draft guidelines drew criticism and a lawsuit from Viropharma, which petitioned the agency more than two years ago to...
Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.
The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.
Altimmune’s stock price did not recover on June 27, after a 57% dip the day before, despite efforts to position pemvidutide as both resolving MASH and offering weight loss.
The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.
The biotech announced positive topline results from the Phase II SUMMIT study in non-advanced systemic mastocytosis, with data for advanced SM and GIST expected later this year.
Still holding out hope after multiple rejections for the tyrosine kinase inhibitor.
In this week's episode: AbbVie’s big autoimmune CAR-T play; In Vivo CAR-T interest grows; China deal perspectives from BIO; global pharma interest in Korea undeterred; and a look at the biggest drug sales disappointments.
