Ono Pharmaceutical Co. Ltd. struck a licensing deal with Ionis Pharmaceuticals Inc. for sapablursen, which is in phase II trials for polycythemia vera. Under terms, Osaka, Japan-based Ono gains an exclusive license to develop and commercialize sapablursen worldwide. Carlsbad, Calif.-based Ionis will be responsible for completing the ongoing phase II Imprssion study, while Ono will be responsible for subsequent development, regulatory filings and commercialization.
In what it says is the biggest obesity deal to date, Zealand Pharma A/S has signed up Roche AG to a potential $5.3 billion global collaboration and license agreement to develop petrelintide, an amylin analog that is currently in phase IIb development. The two companies will co-develop and co-commercialize petrelintide and combination products, including a fixed-dose combination of petrelintide and CT-388, Roche’s dual GLP-1/GIP receptor agonist.
In another real-life episode of “sponsor beware,” the owners of a clinical research facility pleaded guilty March 10 in U.S. district court to fraud charges resulting from their conduct of two clinical trials for potential asthma drugs.
Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.
Positive 16-week extension data from Cervomed Inc.’s phase IIb in dementia with Lewy bodies followed a failure from December. New results from the Rewind-LB trial testing neflamapimod, a brain-penetrant, orally administered small molecule that inhibits the intracellular enzyme p38MAP kinase alpha, have encouraged the company to pursue a phase III study.
Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis.
George Demos, former vice president of drug safety and pharmacovigilance at Acadia Pharmaceuticals Inc., is the latest biopharma executive to plead guilty to insider trading charges.
Three public health experts have voiced concerns that the uncertainties sparked by the Trump administration’s moves to reduce federal spending could limit the U.S. CDC’s ability to track and respond to infectious disease outbreaks and will undermine the public health support system in the U.S.
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster diabetes/weight-loss franchise, could see up to a three-year reprieve if a bipartisan bill recently introduced in the U.S. House and Senate becomes law.
RSS
