Archive for October 2017

Gilead is defending a suite of patents for its profitable hepatitis C antivirals from challenges by a non-profit group petitioning the PTO’s Patent Trial and Appeal Board. Source: Drug Industry Daily

The PTO’s Patent Trials and Appeals Board reversed course last week, granting inter partes review of a Herceptin patent that it previously refused, following challenges from Hospira. Source: Drug Industry Daily

A worker benefits fund filed a lawsuit against Johnson & Johnson this week for allegedly maintaining an illegal monopoly for its Crohn’s disease drug Remicade. Source: Drug Industry Daily

The European Medicines Agency is already changing its procedures in advance of the UK’s departure from the European Union in 2019, with the pending withdrawal affecting which experts the agency appoints to investigate applications for new drug approvals, the agency said. Source: Drug Industry Daily

FDA advisory committee members overwhelmingly recommended approval of Indivior’s RBP-6000, an extended-release reformulation of buprenorphine for the treatment of opioid abuse. Source: Drug Industry Daily

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Source: Drug Industry Daily