With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
Is the U.S. Inflation Reduction Act with its Medicare drug price negotiation provision the new legislative sacred cow that cannot be tweaked? Debate over whether the orphan drug carveout included in the negotiation provision should be extended to drugs with more than one rare disease indication was the major discord in an otherwise bipartisan discussion the House Energy and Commerce Subcommittee on Health had in a hearing held Feb. 29 in observation of Rare Disease Day.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
“The market stinks,” Brian Johnson, a partner and vice chair of Wilmerhale’s corporate practice group, told a U.S. SEC advisory committee Feb. 27, as he painted a gloomy picture of last year’s IPO landscape in the U.S. While the scene was a little brighter than in 2022, a few key indicators could be worrisome, especially the median offering size, which is predictive of the strength of the IPO market, Johnson said
More than a year and a half after the U.S. FTC launched its investigation into how pharmacy benefit manager (PBM) practices and consolidation impact patients’ ability to access and afford their prescription drugs, the six biggest PBMs in the country have yet to fully comply with the agency’s June 2022 order to provide data and documents pertaining to certain business practices.
Drug pricing is playing an outsized role in the dynamics of the November U.S. election, creating turbulence for drug companies and for patients that will extend years after the votes are counted. During a Feb. 27 morning session on drug pricing trends during an election year at the BIO CEO & Investor Conference in New York, key opinion leaders spoke about their concerns, including the need to explain drug-pricing rationale to voters and patients in plain terms.
Allecra Therapeutics GmbH secured U.S. FDA approval for its beta-lactam/beta-lactamase inhibitor combination, Exblifep (cefepime/enmetazobactam), in complicated urinary tract infections, including pyelonephritis, in patients 18 years and older.
In the end, Minerva Neurosciences Inc. NDA submission wasn’t able to overcome the U.S. FDA’s concerns regarding data for dual 5-HT2A/sigma 2 antagonist roluperidone. The agency issued a complete response letter (CRL) for the application, which had been seeking approval as the first treatment specifically targeting negative symptoms of schizophrenia.
Abbvie Inc.’s blockbuster drug Humira is getting a 10th challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by the COVID-19 pandemic and manufacturing issues, the U.S. FDA approved Simlandi, previously known as AVT-02, as a Humira biosimilar and interchangeable Feb. 23.
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