Sanofi SA offered two dispatches of unhappy news regarding the Bruton’s tyrosine kinase inhibitor tolebrutinib, saying the phase III Perseus study failed to meet its primary endpoint in primary progressive multiple sclerosis and that the ongoing U.S. regulatory review in non-relapsing secondary progressive MS (nrSPMS) likely will extend beyond the targeted PDUFA date of Dec. 28. Meanwhile, responding to the FDA, Sanofi has submitted an expanded-access protocol for tolebrutinib. The Paris-based firm said it “strongly believes” in the risk-benefit profile of the drug in nrSPMS.

Immunome’s phase III results in desmoid tumors point to NDA

Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors has prompted the company to say it plans to submit an NDA to the U.S. FDA. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. Immunome’s stock (NASDAQ:IMNM) had risen sharply at midday, with shares at $23.13 each, a jump of 18%. A little more than two years ago, Ogsiveo (nirogacestat), also a gamma secretase inhibitor, from Springworks Therapeutics Inc. was approved by the U.S. FDA and was the first drug specifically indicated for desmoid tumors.

EU agrees to pharma legislation, but the industry isn’t happy

The EU finally reached agreement on an update of the 20-year-old pharmaceutical legislation, more than five years after the EU Commission first put forward the case for reform and following two and a half years of negotiations on the new rules. The political agreement is subject to rubber stamping by the European Parliament and member state health ministers in the EU Council, but that is seen as a formality.

US senators want the lowdown on Trump biopharma pricing deals

A group of eight Democratic senators is asking biopharma companies to spill the beans about their private most-favored-nation pricing deals with U.S. President Donald Trump. Led by Sen. Ron Wyden, D-Ore., the senators sent letters to Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Pfizer Inc. last week seeking the details of those deals. For instance, the senators want to know which of the companies’ drugs are subject to the Medicaid provisions of their agreement and whether those prices are actually lower than the current net pricing states receive for the products.

China eclipses Europe for clinical trial starts: LEK report

China’s clinical trial volume has surged to nearly U.S. scale and now tops Europe, sitting at about 80% of U.S. levels and roughly 10% above the EU in 2024. Favorable policy reforms and sustained R&D investment have transformed China’s clinical development landscape over the past decade, laying the groundwork for the next wave of growth for both multinational and Chinese companies, according to a report by LEK Consulting based on a survey of 89 pharma and CRO leaders.

US Biosecure Act a vote away from law

“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride to becoming law last year, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into this year’s must-pass National Defense Authorization Act, which is just a Senate vote away from becoming law. That vote is expected this week. Meanwhile, a new bipartisan bill has been introduced in the Senate to further protect U.S. biotech innovation by ensuring that cutting-edge American intellectual property isn’t given to China or other foreign adversaries.

The BioWorld Insider podcast: Finding a better, longer-lasting fix in opioid overdose

The opioid crisis may not be front and center anymore, but it’s raging still. A major problem is that overdose-reversal drugs don’t last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm’s candidate for a solution to the medical and societal problem. The NIH – which has been helpful to Elysium since the company’s founding – the FDA, and others are working to advance a longer-lasting reversal agent. Experiments already done with approved reversers, as well as computer modeling that’s been used by regulators previously, will help in the push, Sturmer said.

Also in the news

AB Science, Acadia, Alphyn, Amgen, Anixa, Apellis, Arcus, Ausperbio, Avenzo, Beyondspring, Contineum, Cosette, Cullgen, Dyne, Enveric, Everest Medicines, Genmab, Geron, GSK, Hasten, Hyloris, Immunitybio, Innovent, Innoviva, Kymera, Mayne, Merck, Merus, Novo Nordisk, Oruka, Relay, Serina, Sobi, Stada, Starton, Tenaya, Terns, Tetraneuron, Zegenex