A district judge has issue an Aug. 27 ruling enjoining Biosense Webster Inc. from tying its support for cardiac mapping equipment to purchases of the company’s catheters used in these procedures. According to the Association of Medical Device Reprocessors, the ruling triples previously announced damages, which will now cost Biosense nearly $450 million for violations of state and federal antitrust law.
Three milestones expected to bring the reality of U.S. prescription drug price negotiations into focus are hovering on the horizon. First, the CMS is scheduled to publish its maximum fair prices (MFPs) for the round 2 selected drugs by Nov. 30. Then, on Jan. 1, the MFPs for the first round kick in, affecting not only the 10 selected drugs, but a dozen approved biosimilars referencing the three biologics in that round, 94 generics either approved or tentatively approved that reference the small molecules on the list, and perhaps other innovator drugs in the same therapeutic spaces. And by Feb. 1, CMS must publish the list of up to 15 drugs selected for negotiations for the 2028 price year. That list will be the first to include Part B drugs.
Cohesys Inc. conducted the first test of its resorbable Bonetape in humans as part of an investigational trial for craniofacial fractures. The tape could eliminate the use of drills and screws in many plastic and reconstructive facial surgeries, potentially simplifying procedures and recovery.
Cancel culture continues at the U.S. Department of Health and Human Services (HHS) as it observes National Immunization Awareness Month with another strike against vaccines. This time, a $500 million strike specifically targets 22 mRNA vaccine R&D programs at the Biomedical Advanced Research and Development Authority (BARDA), marking the beginning of the end of BARDA’s funding for mRNA vaccines.
Alcon AG agreed to acquire Staar Surgical Co. in a $1.5 billion cash transaction that would add Staar’s Evo implantable Collamer lenses (ICL) to treat myopia to the vision giant’s portfolio. Alcon will pay $28 per share, a 59% premium on Staar’s 90-day volume-weighted average price and a 51% premium on the Aug. 4 closing price of its shares (Nasdaq: STAA).
After shutting down manufacturers’ efforts last year to offer the mandated 340B discounts on outpatient prescription drugs as a rebate rather than an up-front price, the U.S. Health Resources and Services Administration (HRSA) is now inching the rebate door open for drugs that were selected for the first round of Medicare price negotiations.
The U.S. Court of Appeals for the Federal Circuit recently returned a decision in a case pitting Shockwave Medical Inc. against Cardiovascular Systems Inc. in a decision that adds a new wrinkle to the question of how prior art can and cannot be used to eviscerate a patent.
Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
Boston Scientific Corp. handily beat expectations for sales growth and profits in the second quarter, led by 117% growth for its Farapulse pulsed field ablation system in the U.S. and 23% overall organic increase in revenue for cardiology. The company cut the expected impact of tariffs by 50% and raised guidance for earnings per share and sales for the year.
As Wall Street awaits key phase III data from Abivax SA with microRNA-124 (miR-124)-targeting obefazimod in ulcerative colitis, due this quarter, the inflammatory bowel disease (IBD) space – which also takes in Crohn’s disease – continues to grow and shift with new findings across varied fronts.
