We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The UK’s healthcare cost watchdog issued a mixed bag of recommendations Wednesday, supporting Pfizer’s Inlyta as a second-line treatment for advanced kidney cancer while nixing Dendreon’s Provenge for asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer. Read More
The FDA on Monday granted accelerated approval to Novartis’ Farydak, the first histone deacetylases inhibitor for use in treating multiple myeloma. Read More
The UK’s National Institute for Health and Care Excellence on Friday gave a preliminary nod to two diabetic macular edema products, paving the way for their eventual inclusion in the government’s formulary. Read More
The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Tuesday, making it the fifth publicly disclosed biosimilar application in the U.S. Read More
The FDA gave tentative approval to Mylan’s ANDA for a generic Nexium earlier this month, but denied final approval due to lasting exclusivity protections — almost guaranteeing Teva the only generic version of the blockbuster heartburn drug on the market for months to come.
Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The UK’s health cost-effectiveness watchdog is recommending coverage of Norgine’s Targaxan to treat adults with a serious and potentially life-threatening brain condition caused by liver failure. Read More