Durex licenses VivaGel
This article was originally published in The Tan Sheet
Executive SummarySSL International, the manufacturer of Durex brand condoms, signs a licensing agreement with Starpharma Holdings for marketing rights to a condomcoated with Starpharma's VivaGel, a vaginal microbicide gel under development for the prevention of sexually transmitted infections, including genital herpes and HIV infection, the firms announce Sept. 9. The deal secures SSL the rights to market a VivaGel coated condom in most markets, including Europe and the U.S., and Starpharma estimates it will receive more than $100 million from SSL for royalties on sales, further milestone payments and developmental support, Melbourne, Australia-based Starpharma says. The firm also continues to develop VivaGel as an applicator-delivered vaginal microbicide for women to protect against STIs
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.