Skip to content Skip to footer

NEWS

Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)
Shots: The CHMP has recommended Arrowhead's Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26  Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…
Cumberland Pharmaceuticals Sells Branded Portfolio to Apotex in $100M Deal
Shots: Cumberland has entered into an agreement to sell its portfolio of branded US products to an affiliate of Apotex for $100M in cash, which will create a platform to deliver specialty medicines The move separates Cumberland’s commercial business from its R&D operations, allowing the company to focus on advancing its pipeline product candidates post-closing,…
Mabwell Initiates P-III Trial for 9MW2821 in TNBC
Shots: Mabwell has initiated a P-III trial of 9MW2821 in triple-negative breast cancer (TNBC), marking the fourth pivotal study for 9MW2821 The trial will assess the efficacy of 9MW2821 vs the investigator’s choice chemotherapy in locally advanced or metastatic TNBC pts previously treated with taxane-based CT ± immunotherapy & a topoisomerase inhibitor-based ADC 9MW2821, a…
Crinetics
Crinetics Pharmaceuticals Report the EC Approval of Palsonify for Acromegaly 
Shots:  The EC has approved Palsonify (paltusotine) for treating adults with acromegaly who are ineligible for or inadequately respond to surgery across all 30 EEA states    EC approval was supported by P-III PATHFNDR-1 & PATHFNDR-2 trials evaluating Palsonify in previously treated & medically untreated adults with acromegaly, demonstrating rapid onset, reliable biochemical control & sustained efficacy; it also received ODD in EU  Crinetics plans…