The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically.

Following up on a bipartisan effort to keep down the costs of insulin, U.S. Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) reintroduced a bill on April 20 to ensure patients with diabetes can access the life-saving medicine without the excess costs associated with drug rebates and stymied competition.

Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested.

The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.