Archive for April 2018

In comments to the European Medicines Agency, leading drugmakers requested more clarification, simpler language and various other revisions for the International Conference on Harmonisation’s draft addendum to its E9 guidelines. Source: Drug Industry Daily

Sponsors conducting clinical trials using imaging-based primary endpoints should consider the choice of modality — such as echocardiography or single-photon emission computed tomography — as well as centralized image interpretation and how often image evaluations should be performed, according to final guidance from the FDA. Source: Drug Industry Daily

The UK government aims to stay up-to-date with EU changes for clinical trial procedures amid uncertainties over next March’s implementation of Brexit. Source: Drug Industry Daily

The FDA’s Arthritis and Drug Safety Committee and the Risk Management Advisory Committee voted 15 to 5, with a single abstention, that Pfizer’s PRECISION trial, which compared Celebrex (celecoxib) to ibuprofen and naproxen, demonstrated comparable cardiovascular safety. Source: Drug Industry Daily

The FDA issued final guidance on electronic submissions of drug master files, giving sponsors of Type III DMFs for packaging materials an extra year before submission requirements kick in. Source: Drug Industry Daily

In a landmark decision for patent law, and to the disappointment of some drug makers, the U.S. Supreme Court upheld the legality of inter partes reviews, preserving a method that makes it easier to challenge and invalidate dubious patents. Source: Drug Industry Daily

Adding to the already numerous lawsuits, the Teamsters union sued opioid manufacturers, distributors and pharmacy benefit managers in the U.S. District Court for the Northern District of Ohio over their alleged role in the addiction crisis. Source: Drug Industry Daily

CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes. Source: Drug Industry Daily

The Senate Committee on Health, Education, Labor and Pensions unanimously advanced the Opioid Crisis Response Act (S. 2680) Tuesday but voted down an amendment to impose tough penalties on drugmakers. Source: Drug Industry Daily

Generic drug approvals were in the spotlight during remarks by FDA Commissioner Scott Gottlieb before a Senate appropriations subcommittee on the FDA’s fiscal year 2019 budget request. Source: Drug Industry Daily