We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Janssen Biotech and Samsung Bioepis jointly requested that Janssen’s patent infringement case be dismissed following the Supreme Court’s ruling earlier this year on the biosimilar approval process. The New Jersey federal court agreed to the motion last week. Read More
The chief administrative law judge of the PTO’s Patent Trial and Appeal Board issued guidance to holders on how to amend their patents after being challenged with an inter partes review. Read More
A Philadelphia jury found Bayer and Johnson & Johnson liable for the injuries of a woman prescribed their prescription blood thinner Xarelto, following three consecutive victories for the drugmakers in similar “bellwether” cases. Read More
For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multi-arm, multi-company clinical trials, according to a new draft guidance that the FDA says could help eliminate the need for certain studies. Read More
The FDA’s chief counsel said the agency is examining the legal circumstances where a company’s senior personnel and management could be held not only civilly responsible, but also criminally responsible for the actions of those working under them. Read More