Term sheets are being drawn up with potential pharma partners after Torqur AG reported positive interim results from an ongoing phase II trial of bimiralisib topical gel in the treatment of actinic keratosis.
The pairing of Mallinckrodt plc and Endo Inc. is expected to create a pharma heavyweight that will generate $3.6 billion in 2025 revenue after the duo combines their generic pharmaceuticals businesses and Endo’s sterile injectables setup. Terms call for Dublin-based Endo shareholders to collect $80 million in cash and own 49.9% of the combined firm. Owners of stock in Mallinckrodt will hold the rest of the new entity in the arrangement, which bears an enterprise value of $6.7 billion and is expected to close in the second half of this year.
Vivace Therapeutics Inc. closed a $35 million series D round led by RA Capital Management, an existing investor, and including other backers already on board: Canaan Partners and Cenova Capital. Proceeds will support the continued development of what the company describes as its first-in-class and best-in-class transcriptional enhanced associate domain autopalmitoylation (TEAD) inhibitor, VT-3989, with an initial focus on mesothelioma.
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.
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.
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.
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.
Positive top-line data from phase II and III studies of lorundrostat for treating uncontrolled or resistant hypertension propelled Mineralys Therapeutics Inc.’s stock sharply upward on March 10. The phase III Launch-HTN study hit its primary endpoint in reducing systolic blood pressure and the phase II Advance-HTN study also met its primary endpoint of a clinically meaningful reduction in blood pressure. Oral lorundrostat targets dysregulated mineralcorticoid aldosterone as a selective aldosterone synthase inhibitor. Mineralys estimated there to be about 15- to 20-million patients with uncontrolled hypertension in the U.S. On March 10, the Radnor, Pa.-based company’s shares (NASDAQ:MLYS) closed 42% upward at $14.96 each.