So much for stability at the U.S. FDA. Three weeks after accepting the position as director of the FDA’s CDER, Richard Pazdur has informed the agency of his intention to retire at the end of the year.
The next stop on the comeback tour for the U.S. FDA’s Rare Pediatric Disease Priority Review Voucher program is the Senate, after the House unanimously passed the Mikaela Naylon Give Kids a Chance Act, H.R. 1262, Dec. 1.
The U.K. government has secured a deal guaranteeing there will be no tariffs on the £6.6 billion (US$8.7 billion) of pharmaceutical products exported annually to the U.S., as part of a package of measures under which the U.K. will pay more for patented drugs.
U.S. Health and Human Services Secretary Robert Kennedy continued his last-minute musical chairs ahead of the Dec. 4-5 meeting of the Advisory Committee for Immunization Practices (ACIP) when he named Kirk Milhoan as the new chair of the panel that advises the CDC on vaccine schedules.
Wall Street was sorting through two batches of news from Jasper Therapeutics Inc., which made public positive data from the phase Ib study called Etesian with KIT-targeting briquilimab in adults with allergic asthma, while making known the outcome of a probe into the phase Ib/II Beacon study with the same drug in chronic spontaneous urticaria.
Both the FDA and the CDC’s Advisory Committee for Immunization Practices are on the threshold of revising how vaccines are approved and used in the U.S., but whether that opens to a precipice or a new era of stronger evidence and safer use is in the telling of the beholder.
Protego Biopharma Inc. closed an oversubscribed $130 million series B financing that will be used to advance PROT-001, the company’s treatment for amyloid light (AL) chain amyloidosis. a plasma cell disorder where the cells produce abnormal, misfolded immunoglobulin light chain proteins.
Q32 Bio Inc. handed off rights to phase II-stage complement inhibitor ADX-097 in a deal with Akebia Therapeutics Inc. that helps the former extend its cash runway to focus on lead candidate bempikibart in alopecia areata and bolsters the latter’s efforts to build a rare kidney disease pipeline.
The Sept. 4, 2015, at-risk launch of Sandoz Inc.’s Zarxio as the first biosimilar to hit the U.S. market came several months after the FDA had approved the filgrastim biosimilar due to a court battle over the requirements of the 2010 Biologics Price Competition and Innovation Act, which laid out the rules of the road for the new class of follow-on drugs. Ten years later, biosimilar developers are still struggling with some of those rules that were drafted by Congress in an effort to balance competition with innovation in the biologics space. Insulin biosimilars may be the hardest hit.
The U.S. Centers for Medicare & Medicaid Services (CMS) rolled out negotiated costs of the second batch of drugs subject to such bargaining under the Inflation Reduction Act. Wall Street was not surprised to learn that the numbers amount to much greater cuts than the Biden administration managed for 2026. CMS said the adjusted maximum fair prices would have achieved 44% lower net spending had they been implemented in 2024 – 36% if forgiven discounts from the part D redesign of the Medicare prescription drug benefit are figured in. Fifteen drugs are listed.
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