President Trump’s proposed budget for FY 2019 calls for a major increase in budget authority for the FDA along with a significant increase in user fees. Source: Drug Industry Daily
Sponsors of drugs for treatment of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer should use complete response rates in carcinoma in situ patients as their primary endpoint, the FDA said…
Indivior sued five competitors for infringing on its patent for the Suboxone sublingual film for treatment of opioid dependence. Source: Drug Industry Daily
The FDA declined to approve a Pharmaceutical Manufacturing Research Services NDA for a new oxycodone hydrochloride product due to insufficient evidence of its abuse-deterrent properties, the agency said a Feb.…
Purdue Pharmaceuticals announced that it will no longer promote its opioid products to doctors and will cut its sales force by more than half. Source: Drug Industry Daily
Amicus announced that the FDA accepted its NDA for migalastat to treat Fabry disease in patients with amenable mutations. Source: BioSpace
With the deal in hand, Roivant has stepped into the world of metabolic diseases. Source: BioSpace
The fast-growing company will anchor 399 Binney St., an Alexandria Real Estate Equities property. Source: BioSpace
Mr. Goater succeeds interim chief executive officer Dan Lynch, who will remain executive chairman of Surface’s board of directors. Source: BioSpace
The study assessed two doses of RG7716 versus ranibizumab standard of care given as monthly intravitreal injections. Source: BioSpace