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The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.

The data suggest the high dose nearly closes the efficacy gap with Zepbound.

Biopharma executives make their predictions for the year ahead, from a bold forecast for the return of the megadeal to a plea for the slow, healthy recovery of the industry at large.

Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.

The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival, calling it the “major efficacy outcome” of the trial.

Novartis is locked in a legal back-and-forth with MSN Pharma over alleged patent infringement of its heart failure drug Entresto.

Boehringer Ingelheim’s trio of late-stage schizophrenia failures on Thursday came a day after the Department of Health and Human Services hit back on the pharma’s legal challenge to the IRA’s drug price negotiation program.

As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and pharma executives—and the general comradery in the air throughout the chaotic event.

Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market just yet, forcing the company to “significantly reduce expenses.”

With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.

In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.

After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ gastroparesis drug candidate tradipitant.

Acceptance of TempraMed’s products by Meuhedet Health Services strengthens TempraMed’s B2B institutional commercialization strategy as the Company advances reimbursement initiatives and expands relationships with leading healthcare organizations globally Highlights Meuhedet Health Services, Israel’s third-largest Health Maintenance Organization (HMO), serving more than one million insured members, has accepted TempraMed’s flagship VIVI Cap™ and VIVI Epi™ products. TempraMed products are now accepted by two of Israel’s four national HMOs—Maccabi Healthcare Services and Meuhedet—providing institutional access to approximately four million insured lives. The Company is executing a global B2B institutional strategy focused on healthcare organizations, insurers, distributors and government healthcare systems.

· New research team expands capabilities at Boehringer’s U.S. R&D site in Ridgefield, Connecticut.