A European Medicines Agency committee proposed changes to clarify ambiguities in an international draft guideline for non-clinical studies of oncology drugs. Source: Drug Industry Daily
Sponsors would like to see clearer recommendations for non-inferiority assessments, demonstrating bioequivalence and targets for statistical analysis, before the European Medicines Agency adopts an international guideline on large clinical trials…
Sandoz is arguing the Federal Circuit misinterpreted federal law when ruling that biosimilar makers must wait six months after an FDA approval to launch a product. Source: Drug Industry Daily
In a loss for Shire, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit ruled Actavis did not infringe a patent covering the ulcerative colitis drug…
Two congressmen sent a letter to the CEO of Marathon Pharmaceuticals, calling the company’s decision to market an old drug for Duchenne muscular dystrophy for $89,000 per year as “outrageous”…
The European Medicines Agency saw a 28 percent increase in the number of applications for orphan product designations in 2016 compared to the previous year. Source: Drug Industry Daily
Regeneron Pharmaceuticals received a subpoena last month as part of a Department of Justice investigation into the nonprofit organizations that play a key role in reducing the sticker price of…
An appeals court has revived a class action suit charging that Takeda stifled generic competition. Source: Drug Industry Daily
The Justice Department filed a motion to intervene in a multistate antitrust lawsuit accusing six generics makers of colluding to raise the prices of the antibiotic doxycycline hyclate and the…
Sen. Chuck Grassley (R-Iowa) is planning to examine the FDA’s orphan drug programs to find out if companies are using the designation to justify higher prices for common drugs. Source:…