The first round of the U.S.’ Medicare negotiations accounted for a lot of digital ink and headlines in 2024. Next year is sure to bring more of the same as Medicare is to announce up to 15 Part D drugs to be negotiated in the second round by Feb. 1, even as several constitutional challenges to the process continue in federal appeals courts across the country. Although the Supreme Court’s landmark decision in Loper Bright came down after some of the challenges were dismissed at the district court level, it could play into the litigation, especially the challenge brought by Novo Nordisk A/S, as the cases progress through the appellate courts. Like the other companies challenging the negotiations, Novo Nordisk raised constitutional issues, but it also questioned CMS’ authority to implement a rule that went beyond the provisions Congress spelled out in the Inflation Reduction Act.

Drug importation schemes add to call for US PBM reforms

Even though pharmacy benefit manager (PBM) reforms were dropped from the continuing resolution Congress passed Friday to keep the U.S. government fully functional through March 14, the incoming administration and Congress likely will continue to try to rein in the PBMs, which serve as middlemen in the nation’s drug supply chain. Adding to the pressure for reforms are ongoing court cases challenging the practices of PBM conglomerates and their partners. In one such suit, the U.S. District Court for the District of Maryland recently granted Gilead Sciences Inc. a temporary restraining order against an illegal drug importation scheme involving an insurer, PBM, its partnered “alternative funding program” and that program’s mail-order pharmacy, all of which are based in the U.S. According to Gilead’s complaint, the insurance plan refused to cover a patient’s HIV drug unless it was obtained through the partnering mail-order pharmacy. Although the drug that was delivered bore the Gilead name and trademark, the labeling was all in Turkish, and the drug was not approved by the FDA.

In 2024, pandemic breakthroughs were for better and for worse 

First, the good news about pandemics – and in 2024, there was big “good news.” Science Magazine named lenacapavir (Gilead Sciences Inc.) as the Breakthrough of the Year. In two separate trials, lenacapavir prevented HIV transmission with 100% efficacy in cisgender African women and 99.9% efficacy in men and gender-diverse persons when administered twice a year. The trial results were reported in The New England Journal of Medicine and at the 2024 Meeting of the International AIDS Society. Lenacapavir does not obviate the ultimate need for an HIV vaccine to gain the upper hand over the pandemic. It is for use by high-risk individuals only, in part because it will be far more expensive than a vaccine.

The map for a journey to the center of the brain

In the 1970s, scientists from several countries proposed to reconstruct, one by one, all the neurons in the brain as they appear under an electron microscope. They started with a small worm. Caenorhabditis elegans has only 302 neurons. It took 16 years. How much time would be required to repeat this arduous task for the 100 billion neurons in the human brain? The year 2024 marks a milestone with the end of a long journey: a complete cellular map of the fruit fly brain, Drosophila melanogaster, and a cubic millimeter of the human brain. The adventure is just beginning for the thinking species Homo sapiens. “I suspect there are millions of things in there that nobody knows yet. It is truly like being on a weird island where you are walking around and you see something that no one ever saw before,” Jeff Lichtman, professor at the Center for Brain Science at Harvard University, told BioWorld.

Holiday notice

BioWorld's offices will be closed in observance of Christmas. No issues will be published Wednesday, Dec. 25 or Thursday, Dec. 26.

Also in the news

Abivax, Anebulo, Astrazeneca, Bristol Meyers Squibb, Cadrenal, Corxel, Eli Lilly, Glaukos, Ikena Oncology, Inmagene, Jemincare, Keymed, Neurosense, Nuvation, Novo Nordisk, Pfizer, Psyence, Rapt, Rhythm, Sumitomo, Tme, Tonix, Traws, Vertex, Vicentage, Vyne, Xbiotech