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…

Two Endo International subsidiaries sued the FDA last week to have the agency’s bulk drug compounding decree on compounding operations declared illegal and to halt compounding involving the API vasopressin.…

The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in…

The European Medicines Agency published a new draft guideline on developing medicines and vaccines against respiratory syncytial virus infections, including monoclonal antibodies and direct-acting antivirals. Source: Drug Industry Daily

The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement.…

The FDA is looking for creative approaches to the opioid crisis, including new requirements for product packaging, as ways to reduce overall exposure to the painkillers. Source: Drug Industry Daily

Source: Drug Industry Daily