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 FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Feb. 17, making it the fifth publicly disclosed biosimilar application in the U.S. Read More
The UK’s healthcare cost watchdog today gave a positive nod to Gilead Sciences’ hepatitis C combination therapy Harvoni for certain genotype 1 and 4 patients. Read More
The FDA on Friday approved Actavis and Medicines 360’s Liletta, a drug-eluting intrauterine device that prevents pregnancy for up to three years. Read More
Australian drugmakers want the government to create fast-track approval pathways for new cancer drugs, as well as parallel review processes that simultaneously assess safety and efficacy and reimbursement eligibility for new drugs. Read More
The FDA Wednesday approved Actavis’ Avycaz, a new antibiotic for adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade – just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More
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