A California prosecutor is suing Boehringer Ingelheim and a Teva subsidiary, saying their $120 million agreement to push back the release of a generic Aggrenox blood thinner illegally delayed market…
Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from…
South Korean biosimilars firm Celltrion is challenging the validity of four Genentech patents for combination therapies to treat metastatic breast cancer. Source: Generic Line
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Source: Generic Line
A complaint from the Federal Trade Commission alleges Shire ViroPharma unlawfully stifled generic competition. Source: Generic Line
In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate…
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…
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Source: Generic Line
Twenty states have joined an antitrust lawsuit accusing six generics makers of colluding to fix the price of generic versions of antibiotic doxycycline hyclate and the diabetes drug glyburide. Source:…
Eli Lilly & Co. had their patent sustained by a federal appeals court, barring generics manufacturer Teva Pharmaceuticals from marketing its own version of the billion-dollar cancer drug Alimta. Source:…