Boston Scientific Corp. has invested $1.5 billion for a 34% equity stake in Mirus LLC in a deal under which it is also gaining an exclusive option to acquire the Siegel balloon expandable transcatheter aortic valve replacement (TAVR) system.

On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid for re-election.

It looks like the end of the road for many of the court challenges to the Inflation Reduction Act’s (IRA) provision requiring Medicare to negotiate prescription drug prices. The U.S. Supreme Court denied cert May 18 to petitions brought by six biopharma companies that raised questions about the constitutionality of the negotiations. All but one of the suits involved were denied in the Third Circuit; the other one was denied in the Second Circuit, so there is no circuit split – yet.

Regeneron Pharmaceuticals Inc. stuck with the tradition of releasing bad news on Friday afternoon and good news on Monday morning with a pair of announcements bracketing the weekend. On May 15, 2026, the Tarrytown, N.Y.-based company announced disappointing data for its LAG-3 inhibitor fianlimab. And then on May 18, 2026, Regeneron announced better news in the form of a deal with Parabilis Medicines Inc.

Patients on antihypertensive medications who still struggle with high blood pressure now have a new treatment option, following the U.S. FDA’s approval of Astrazeneca plc’s baxdrostat. Branded Baxfendy, the drug is a first-in-class aldosterone synthase inhibitor, though it could be joined soon by potential competitor Mineralys Therapeutics Inc., which has a December 2026 PDUFA date for its aldosterone synthase inhibitor, lorundrostat.

Temperature matters when determining pH levels. Whether that level should be measured at a standard room temperature or refrigerated matters even more, at least in Actelion Ltd.’s infringement litigation against Mylan Inc. According to Johnson & Johnson’s Actelion, the pH level in epoprostenol, the key ingredient in its hypertension drug Veletri, should be measured at a refrigerated temperature when it comes to Mylan’s generic formulation.

The number of cases of hantavirus infection has risen from eight to 11, following the repatriation of passengers from the cruise ship MV Hondius, with World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus warning the danger is not over. “In fact, it has entered a new phase as the passengers and crew return home,” he told attendees of a meeting at WHO’s headquarters in Geneva on May 13.

The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy.

How the U.S. FDA might view the latest Duchenne muscular dystrophy (DMD) phase III data with gene therapy RGX-202 became the question for Regenxbio Inc., shares of which  (NASDAQ:RGNX) closed May 14 at $6.25, down 38%, or $3.80, after the results were made public.

Biogen Inc. has decided to advance diranersen (BIIB-080) into registrational trials for early Alzheimer’s disease, even though the antisense oligonucleotide therapy, originally discovered by Ionis Pharmaceuticals Inc., missed its phase II primary endpoint.