Round 2 of the U.S. Medicare price negotiations officially began late Oct. 2 with CMS’ release of its final playbook and timeline, which build on lessons learned from the first round and comments on a draft negotiations guidance that was published in May. In response to the feedback CMS received, the second round will allow for more patient-focused sessions and offer increased engagement with the makers of the drugs selected for negotiations.
It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct. 1 letter that took FDA Commissioner Robert Califf to task for letting the FTC do the FDA’s job.
Depending on how long it lasts, the dockworkers strike that hit all 14 ports on the U.S. East Coast and along the Gulf Oct. 1 could literally unload a world of hurt to patients and the biopharma/med-tech industries, as it will impact both U.S. imports and exports of life-saving drugs and technologies.
Meeting the deadline the U.S. Health Resources & Services Administration imposed in a Sept. 27 final warning letter, Johnson & Johnson (J&J) notified the agency Sept. 30 that it would not implement its proposed 340B rebate model pending resolution of the issues.
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20.
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20. The spending bill is now awaiting President Joe Biden’s signature.
Given the demand for Ozempic and Wegovy and the revenue the GLP-1 drugs are generating for Novo Nordisk A/S in the U.S., a lot of generic companies are clamoring to cash in on the drugs’ current popularity. And there are some U.S. lawmakers more than willing to oblige.
While in the hot seat at a Sept. 24 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing, Novo Nordisk A/S President and CEO Lars Fruergaard Jørgensen said he would sit down with Sen. Bernie Sanders (I-Vt.) and the three largest pharmacy benefit managers to discuss lowering the list prices for the company’s popular diabetes and weight-loss drugs, Ozempic and Wegovy.
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
When the U.S. FTC filed suit Sept. 20 against the country’s three largest pharmacy benefit managers over their alleged use of rebates to artificially inflate U.S. insulin prices, it also put the three big insulin makers, and other drug manufacturers, on notice that they could be next.
