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Patent cases involving payments to delay generic competition have dropped 27 percent following a 2013 challenge to the practice, according to the Federal Trade Commission. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More
While the FDA is speeding many drugs to the market, the agency lacks reliable, accessible data needed to conduct systematic oversight and meet postmarket safety reporting responsibilities, says a GAO report released Thursday. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
In observance of Martin Luther King Day holiday, Drug Industry Daily will not be published Monday, Jan. 18. The next issue will be published Tuesday, Jan. 19. Read More
Valeant’s access program with Walgreens, which the company says will make the company’s products affordable, is slated to kick off this Friday with dermatology brands, according to Ari Kellen, executive vice president and company group chairman. Read More
The FDA continues to turn up the heat on compounding pharmacies, issuing two warning letters to compounders in Kentucky and California for serious GMP deficiencies related to sterility. Read More
With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of clinical tools gathered together under a new pilot program. Read More
Biosimilar developers can expect the FDA to demand costly clinical trials to verify that a biosimilar is effectively identical with a reference product. Read More