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.
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
Manufacturers seeking approval of biosimilars in Europe will be able to use comparator biologics authorized outside the EU to gain marketing clearance. Read More
A top FDA generic drug official said the agency is implementing various initiatives to improve the way it communicates with manufacturers, including through the revision of an internal document on staff interactions with industry. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More
For the first time, pharmaceutical manufacturers will have to report certain financial payments to continuing medical education programs (CME) under the Physician Payments Sunshine Act. Read More
Sales of orphan drugs are expected to grow more than twice as fast as non-orphan drugs in the U.S., Europe and Japan in the coming years, as drugmakers take advantage of lower costs for clinical trials and higher prices when products launch, a new report shows. 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
Bio-Rad Laboratories agreed to pay $55 million to settle federal investigations charging its subsidiaries bribed foreign officials in Russia, Vietnam and Thailand to win business. 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