The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.
Days after Pfizer Inc. pulled the plug on its oral GLP-1 candidate danuglipron, Eli Lilly and Co. aired positive top-line data from the phase III trial called Achieve-1 testing orforglipron vs. placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone.
Glycomine Inc. secured $115 million in a series C financing round to support the advancement of GLM-101 into a phase IIb study in patients with phosphomannomutase-2 congenital disorder of glycosylation (PMM2-CDG).
In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. “My first term included numerous significant actions, including some of the most aggressive in recent history, to deliver lower prescription drug prices to American patients,” Trump noted in the order, which builds on many of those actions, including increased competition, re-importation, price transparency and a mandate to pass discounts through to patients.
Phase I/II trial results of sacituzumab tirumotecan (sac-TMT; Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.) published in Nature Medicine came a month after China’s National Medical Products Administration gave clearance to Kelun-Biotech’s supplemental NDA of sac-TMT to treat advanced non-small-cell lung cancer (NSCLC).
Despite missing a phase II study’s primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III program in the crowded disease space. Preliminary results showed the annualized exacerbation rate endpoint wasn’t met at the highest dosage of amlitelimab. Those numbers, at week 48, showed nominal significance at the medium dose.
After dropping development in December of its lead program, Spruce Biosciences Inc. has found new life by acquiring a BLA-ready enzyme replacement therapy for the rare genetic neurodegenerative disease Sanfilippo syndrome type B. If approved, the therapy, tralesinidase alfa, could bring Spruce a priority review voucher.
Oral peptide delivery specialist Cyprumed GmbH is about to find out if the high bioavailability of its tablet formulations seen in animal models will translate across to humans, after signing a $493 million license and option agreement with Merck & Co. Inc.
U.S. tariffs on biopharmaceuticals have advanced beyond administration talking points.As a precursor to tariffs, Commerce Secretary Howard Lutnick initiated an investigation under section 232 of the Trade Expansion Act to determine the effects on national security of importing prescription drugs, according to a request for public comments scheduled to be published in the April 16 Federal Register. Publication of the notice will kick off a 21-day comment period.
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