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
The biggest challenge for the FDA’s 10-year-old Sentinel program for post-market safety monitoring of medical products is having to deal with a wide range of partners and data sources, according…
The Council of Economic Advisers issued new recommendations for reducing drug pricing, including changes in government policies and regulations, such as moving Medicare Part B drug coverage into Part D.…
The budget deal approved by lawmakers in the early hours on Friday raised caps on non-defense discretionary spending by $63 billion in fiscal 2018 and $68 billion in fiscal 2019,…
The FDA issued Wuhan Chinese Moxibustion Technology a warning letter for manufacturing adulterated products, and for quality and sanitation deficiencies. Source: Drug Industry Daily
A bipartisan group of members of the Senate Health Committee introduced a bill to increase National Institutes of Health research into non-opioid pain treatments. Source: Drug Industry Daily
A Washington, D.C. law firm petitioned the U.S. Attorney’s Office in Boston to reopen an investigation of Forest Laboratories, claiming the company misrepresented clinical trial results used as the basis…