The FDA fi­nal­ly ap­proved the treat­ment — with a boxed warn­ing — on Au­gust 19, 2015, the very next day Sprout an­nounced it was be­ing sold to Valeant (now Bausch Health) for a tidy $1 bil­lion. Unlock this story instantly and join 91,500+ biopharma pros reading Endpoints daily — and it's free. Sprout had asked for complete removal of the boxed warning and any mention of alcohol being contraindicated, according to the FDA announcement. This category only includes cookies that ensures basic functionalities and security features of the website. FDA tells Sprout Phar­ma, like it or not the black box on Ad­dyi stays, but we will di­lute the warn­ing . For a gene therapy tech upstart that launched out of stealth mode just 5 months ago with big goals and not a tremendous amount of launch money, Dyno Therapeutics has quickly moved itself into a frontline offensive in R&D — working in league with some of the marquee developers in the field. The biotech says their lead drug GB001 failed the primary endpoint in their dose-ranging asthma study as well as all the endpoints in a parallel trial they ran for chronic rhinosinusitis. Building on alliances with Novartis and Sarepta, the global Roche/Genentech group has now stepped in with the latest discovery deal, willing to wager up to $1.8 billion that the spinout from George Church’s lab at Harvard has what it takes to deliver on AAV 2.0. The reg­u­la­tor has prover­bial­ly put its foot down and is com­pelling Ad­dyi mak­er Sprout Phar­ma­ceu­ti­cals to make the change af­ter the two par­ties were un­able to reach an agree­ment. This website uses cookies to improve your experience while you navigate through the website. "Today, with Addyi, Canadian women have access to the first ever treatment for their most common sexual dysfunction after decades of men having access to a myriad of options for their own," said Cindy Eckert, CEO of Sprout Pharmaceuticals. All Rights Reserved. FORTUNE is a trademark of Fortune Media IP Limited, registered in the U.S. and other countries. Joffe now serves as the acting director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. These cookies do not store any personal information. These cookies will be stored in your browser only with your consent. Sprout pur­chased flibanserin from Ger­many’s Boehringer In­gel­heim, which orig­i­nal­ly de­vel­oped it and took it to the FDA, on­ly to be de­nied ap­proval in 2010. Natalie Grover Reporter. The initial data presented for Addyi’s approval showed a concerning benefit-risk profile, with risks for hypotension and syncope, especially when the drug was taken with alcohol. The agency’s decision followed a favorable 18-6 vote when the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly earlier that year to consider approving Addyi. An NIH trial for an Eli Lilly antibody, one of two coronavirus drugs President Trump has touted and urged the FDA to authorize in recent weeks, has been halted over a safety concern. Johnson & Johnson has voluntarily ordered a halt to all of its Covid-19 vaccine studies so investigators can probe the unexplained illness of one of the people in their study. This year, about a third of the awards were given to “heroes” of the pandemic, according to The Guardian. The study, known as ACTIV-3, compared the Lilly antibody plus remdesivir to the antibody plus placebo in hospitalized Covid-19 patients and was slated to enroll up to 10,000 volunteers. GlaxoSmithKline CEO Emma Walmsley is adding a royal title to her name.