Mari Serebrov

As if there weren't enough voices chiming in on U.S. childhood vaccine recommendations, there's now one more. President Donald Trump, the commander in chief and now apparently an authority on vaccines, issued an executive order (EO) Aug. 10 with his own recommendations. In keeping with his flair for hyperbole, Trump's calling them the “Gold Standard Childhood Vaccine Recommendations.” He said the new schedule, which includes three categories of recommendations, is based on a “scientific assessment” Health and Human Services released in January.

Bristol Myers Squibb Co. (BMS) will have to face a trustee suit claiming it slow-walked the U.S. FDA drug approval of Breyanzi, a gene therapy targeting non-Hodgkin lymphoma, to avoid milestone payments that were part of its historic $74 billion acquisition of Celgene Corp. in 2019.

In addition to handing Gilead Sciences Inc. a win, the U.S. Court of Appeals for the Fourth Circuit agreed that drug manufacturers can use their trademarks under the Lanham Act to fight back against the importation of international, non-FDA-approved versions of their trademarked therapies.

It's official. U.S. President Donald Trump announced on social media Aug. 19 that he's nominating Heidi Overton to be the next FDA commissioner. Calling her a “rockstar” in his administration, Trump said, “We need her leadership at the FDA now to ensure that the U.S. remains the WORLD LEADER for Scientific Discovery and CURES.”

While other biopharma challenges to the Inflation Reduction Act's (IRA) Medicare price negotiations have failed, the U.S. Court of Appeals for the District of Columbia Circuit opened the courtroom doors Aug. 18 to a Teva Pharmaceutical Industries Ltd. argument despite the litigation bar Congress wrote into the provision.

As the U.S. FDA's CDRH continues to try to wrap its head around the regulatory challenges presented by generative AI (GenAI)-enabled medical devices, it's asking stakeholders to join the conversation on its recently released discussion paper.

While controversy continues to embroil U.S. President Donald Trump's Aug. 10 executive order on childhood vaccines, the Department of Health and Human Services is seeking comments on the three categories of immunizations included in that order – routine (universal) recommendations, risk-based recommendations and recommendations based on shared clinical decision-making, also known as individual-based decision-making.

Perhaps the only surprise in a U.S. district court's Aug. 24 summary judgment against Merck & Co.

It's been 22 years since Amgen Inc. obtained exclusive rights to two etanercept patent applications. No one seemed to pay much attention at the time. Not even the U.S. FTC, which reviews patent acquisitions and exclusive patent licenses under the Hart-Scott-Rodino Act. But when the patents issued several years later, extending the protection for Amgen's blockbuster inflammatory disease drug, Enbrel, until 2029, eyebrows shot up. After all, up until then, Enbrel would have lost patent protection in 2012, making it fair game for early biosimilar competition. Now with the Sherman Act's four-year statute of limitations long over, the FTC is trying to make up for lost time with an amicus brief it filed in the U.S. Court of Appeals for the Fourth Circuit.

The best hope of a circuit split that would send the constitutional challenges to the Inflation Reduction Act's (IRA) Medicare price negotiations to the U.S. Supreme Court died when the Fifth Circuit joined its sister appellate courts in rejecting those arguments. However, rather than extensively relying on similar rulings from the other circuits, the Aug. 26 Fifth Circuit opinion provided its own take on the challenges in affirming a lower court's grant of summary judgment against the Pharmaceutical Research and Manufacturers of America, National Infusion Center Association and Global Colon Cancer Association.