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Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared with previous accelerated approvals for IgA nephropathy.

The discounts should be compared against the drugs’ “ultimate net price” rather than their indicated list price to gauge the true impact of the negotiations, BMO Capital Markets analysts said.

Imfinzi is the first immunotherapy approved for perioperative use to treat gastric and gastroesophageal junction cancers.

A coordinated national effort is emerging to bring alternatives to animal testing into routine preclinical use, backed by a fresh FDA roadmap and a global coalition of scientific and industry partners. 

The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.

The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.

At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.

Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.

Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.

Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”

Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.

Alicia Jackson formerly served as deputy director of the Biological Technologies Office at the Defense Advanced Research Projects Agency.

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.