The U.S. Court of Appeals for the Federal Circuit declined an invitation in United Therapeutics Corp. v. Liquidia Technologies Inc. to expand the enablement and written description bar for biopharma claims into the realm of regulatory approval.
A day after a U.S. House committee, on a party-line vote, advanced two bills to reauthorize emergency preparedness programs, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 17-3 July 20 to send its bipartisan reauthorization of the Pandemic and All Hazards Preparedness Act to the Senate floor with a do-pass recommendation.
Nearly 13 years after Congress created a biosimilars path to bring competition to the U.S. biologics market, new rules of the road are coming into play, via the Inflation Reduction Act (IRA), that could change the course for biosimilars in the long haul – if the IRA’s prescription drug price negotiation mandate withstands numerous constitutional challenges.
Johnson & Johnson and its Janssen pharmaceutical companies added their name July 18 to the growing list of biopharma companies and organizations challenging the Inflation Reduction Act’s (IRA) mandated drug price negotiations.
The U.S. SEC is settling insider trading charges against Nirdosh Jagota, former vice president of global regulatory affairs at Merck & Co. Inc., stemming from Merck’s $1.85 billion acquisition of Pandion Therapeutics Inc. in 2021.
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.
Sanofi SA and Astrazeneca plc had a lot to celebrate July 17 when the FDA approved Beyfortus (nirsevimab) ahead of schedule, making it the first respiratory syncytial virus (RSV) prophylactic for infants in the U.S. “This is just really an historic day,” Michael Greenberg, a Sanofi vice president and medical head of the company’s North America vaccines unit, told BioWorld. The companies had been expecting the FDA decision later this quarter. The earlier approval suggests the FDA appreciated the urgency of having time for health systems and doctors to get the drug ahead of the next RSV season, Greenberg said.
Showing that much lower brand prices are possible, even in the U.S., Theracosbio Inc. announced July 13 that its diabetes drug, Brenzavvy (bexagliflozin), is coming to the U.S. market through the Mark Cuban Cost Plus Drug Co. at a monthly price that’s less than the copay most patients have to pay for other drugs in the class. A new molecular entity approved in January to improve glycemic control in adults with type 2 diabetes, Brenzavvy is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor that will be available through Cost Plus Drugs with a monthly price tag of $47.85, plus shipping and handling. A 30-day supply of other SGLT2 inhibitors costs hundreds of dollars, with some approaching $600 a month.
The tension of clashing politics, policies and prescription drug pricing is coming to a head as U.S. Sen. Bernie Sanders (I-Vt.) acts on his threat to hold presidential appointments in the health arena hostage until President Joe Biden commits to do more to bring down drug prices.
The Association for Accessible Medicines fired off a constitutional challenge in U.S. federal court July 5 to provisions included in Minnesota’s new budget law that would restrict price increases for generic and off-patent drugs.
