20 October, 03:19
#Phispers Week 41 - Weekly Pharma News Recap
Bonjour,
- FDA publishes GDUFA III user fees, increases ANDA, DMF fees.
- Merck’s cardiovascular disease drug succeeds in late-stage trial, validates US$ 11.5 bn Acceleron buyout.
- FDA grants fast-track status to Lilly’s diabetes drug Mounjaro to treat obesity.
- Bayer’s Vividion signs potential US$ 930 million oncology deal with Tavros.
- GSK’s Boostrix vaccine gets add-on approval to prevent whooping cough in infants.
- Sanofi, Regeneron flaunt Dupixent’s benefit in eosinophilic esophagitis trial in kids.
- Two-year data on Roche’s Evrysdi shows benefit in spinal muscular atrophy.
- US ADHD drug crisis deepens as Novartis’ Sandoz also reports shortage of Adderall.
- EDQM finds one major deficiency at Biocon’s API facility in Bengaluru.
#Phispers This Week - PharmaCompass.com's Weekly News Recap
#Healthcare #pharmaceuticals #pharmanews #pharmaceuticalindustry
https://lnkd.in/dE5X4qag
Bonjour,
- FDA publishes GDUFA III user fees, increases ANDA, DMF fees.
- Merck’s cardiovascular disease drug succeeds in late-stage trial, validates US$ 11.5 bn Acceleron buyout.
- FDA grants fast-track status to Lilly’s diabetes drug Mounjaro to treat obesity.
- Bayer’s Vividion signs potential US$ 930 million oncology deal with Tavros.
- GSK’s Boostrix vaccine gets add-on approval to prevent whooping cough in infants.
- Sanofi, Regeneron flaunt Dupixent’s benefit in eosinophilic esophagitis trial in kids.
- Two-year data on Roche’s Evrysdi shows benefit in spinal muscular atrophy.
- US ADHD drug crisis deepens as Novartis’ Sandoz also reports shortage of Adderall.
- EDQM finds one major deficiency at Biocon’s API facility in Bengaluru.
#Phispers This Week - PharmaCompass.com's Weekly News Recap
#Healthcare #pharmaceuticals #pharmanews #pharmaceuticalindustry
https://lnkd.in/dE5X4qag
FDA steps up user fee under GDUFA III; Merck’s heart drug succeeds in late-stage study | Radio Compass Phisper
On September 30, the US President Joe Biden had signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2027. In this week’s Phispers, we bring you the new GDUFA III fe...
https://lnkd.in/dE5X4qag
