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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
Any brand drugmaker in Europe can now sue to block the approval of a generic product that uses the brand’s drug as a reference, according to a recent ruling the EU’s highest court. Read More
Nymox Pharmaceutical’s investigational treatment for enlarged prostate failed to meet primary endpoints in two Phase III tests, after posting stronger results in previous trials. Read More
The FDA is seeking public input on its efforts to facilitate patient participation in the regulatory approval process and on ways to assess those patient engagement activities. Read More