In a historic first, the U.S. Centers for Medicare & Medicaid Services (CMS) sent out its opening offers Feb. 1 for the first round of prescription drug price negotiations.
No subpoena will be needed to force the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. to appear before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, as apparently the threat was enough to get the CEOs to agree to testify at a committee hearing on U.S. drug prices.
With U.S. drug prices a perennial issue, several lawmakers, both Democrats and Republicans, are increasingly looking beyond biopharma to identify other “persons of interest” that may be complicit in the high list prices facing American patients.
The list of 10 part D Medicare drugs listed by the Centers for Medicare & Medicaid Services (CMS) as eligible for negotiation raised some eyebrows on Wall Street, but proved mostly in accord with what the industry expected. Under the Inflation Reduction Act, Medicare can for the first time bargain with drug companies. The back-and-forth begins this year, carrying into next year, and the agreed-upon prices will take effect in 2026.
It didn’t take long for the filing of a second constitutional challenge to the U.S. Inflation Reduction Act’s price negotiations for prescription drugs. In the wake of a similar suit filed three days earlier by Merck & Co. Inc., the Chamber of Commerce filed a complaint June 9 in the U.S. District Court for the Southern District of Ohio.
Aethon Therapeutics Inc. closed a $30 million series A round to develop a novel antibody-based therapeutic strategy for cancer, which relies on the concomitant use of small-molecule covalent inhibitors that form peptide-drug conjugates or beacons.
As the American Society of Clinical Oncology (ASCO) meeting began, researchers discussed abstracts related to findings due to roll out during the course of the weekend event. On the table June 3 were primary results from the double‐blind, placebo‐controlled, phase III Shine study of Imbruvica (ibrutinib) from Abbvie Inc. and Johnson & Johnson (J&J) in combination with bendamustine‐rituximab and rituximab maintenance therapy as a first‐line treatment for patients ages 65 and over with mantle cell lymphoma.
Australians with mantle cell lymphoma (MCL) will now have subsidized access to Beigene Ltd.’s BTK inhibitor, Brukinsa (zanubrutinib), as of March 1, marking the company’s first drug to be listed on Australia’s Prescription Benefits Scheme (PBS).
There’s nothing like beginning-of-the-year price increases to turn up the heat on the prescription drug pricing debate in the U.S. This year is no exception. Citing a mean price increase of 5.1% on brand drugs in the first 25 days of 2022, 13 Democratic lawmakers, led by Sen. Elizabeth Warren (D-Mass.), wrote this week to Steven Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, demanding an explanation for those hikes.
Nurix Therapeutics Inc.’s Dec. 12 disclosure that the U.K. Medicines & Healthcare products Regulatory Agency granted to clearance for the company to kick off a phase I study with Bruton tyrosine kinase (BTK) inhibitor NX-5948 pumped more juice into the space, which has been consistently intriguing since the first drug in the class was approved about eight years ago by the FDA. The San Francisco-based firm will start an experiment in patients with relapsed and refractory B-cell malignancies at clinical sites in the U.K., with dosing of the first subject expected in the first half of 2022.