The U.K.’s National Institute for Health and Care Excellence published guidances for three drugs in four indications, recommending their use by the NHS as long as the sponsors comply with…

FDA advisory committee members recommended approval for some versions of Braeburn’s modified-release reformulation of buprenorphine but balked at endorsing higher dosages of the medication, which is indicated for weekly or…

The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Source: Drug…

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…

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…

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…

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…