Apotex has called on the FDA to require testing on the intended patient population before approving biosimilars. Source: Generic Line

Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — not a month after…

For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro…

In a lawsuit filed Monday, Sanofi says Mylan’s anticompetitive business practices blocked its EpiPen competitor, the Auvi-Q, from gaining a foothold in the epinephrine auto-injector market, resulting in hundreds of…

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…