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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
Gilead Sciences could soon lose its dominance of the hepatitis C market, as payers hint they may abandon the company’s blockbuster Sovaldi in favor of lower-cost alternatives that are expected to launch in the coming months. 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
AstraZeneca has filed a patent infringement lawsuit against Actavis subsidiary Watson over a proposed generic version of AZ’s diabetes drug Kombiglyze XR. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city. The agency also banned products from another India firm. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More