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 made progress addressing its looming ANDA backlog, assigning 65 percent of the languishing applications a targeted action date, say top agency officials, who add that new generic drug review processes will improve response rates going forward. Read More
The UK’s health care costs regulator has recommended coverage of GlaxoSmithKline’s Arzerra as a cost-effective option for untreated chronic lymphocytic leukemia (CLL), offering another drug for treating the most common form of leukemia in England. Read More
The FDA is seeking industry feedback on burdens related to its regulations of clinical investigations on the safety and effectiveness of unapproved new drugs and biologics. Read More
The FDA conditionally approved Veloxis Pharmaceuticals’ organ-rejection drug Envarsus XR, but says the company must wait until the patent on a rival’s product has expired before launching; a decision that the company disputes. Read More
Amgen is asking the FDA to require that all biosimilar filers send a full copy of their application to the innovator company, a position that parallels the company’s lawsuit opposing Sandoz’s bid to make a version of its chemotherapy product Neupogen. Read More
The FDA has cleared new prescribing information for Sanofi Pasteur’s Fluzone High-Dose influenza vaccine, indicating it provides improved protection for adults 65 years and older. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
FDA advisors have recommended approval of Daiichi Sankyo’s proposed blood thinner to treat certain patients with atrial fibrillation, putting the Japanese drugmaker one step closer to entering a fierce competition to replace the decades-old treatment warfarin. Read More
Makers of influenza vaccines in Europe will have more leeway in what they must submit for products to treat pandemics, according to a final guideline that consolidates procedures for submitting applications for all types of flu vaccines. Read More
AstraZeneca said it plans to launch its new two-in-one diabetes pill Xigduo XR early next year in the U.S. after winning FDA approval this week. Read More
Amgen is suing Sandoz to stop the French drugmaker from marketing a biosimilar of its top-selling product Neupogen in the U.S., charging that Sandoz didn’t follow the rules for biosimilar development. Read More