Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy.
Synox Therapeutics Ltd. is preparing to file for FDA approval of emactuzumab in treating tenosynovial giant cell tumor (TGCT), after announcing positive top-line phase III results.
C4 Therapeutics Inc.’s degrader-antibody conjugate (DAC) strategy gathered more steam with a new collaboration between the firm and Roche AG that brings $20 million up front with the potential for more than $1 billion in discovery, regulatory and commercial milestone payments.
Newco Immutrin Ltd. has raised £65 million (US$86.9 million) in a series A to take its lead antibody program through to clinical proof of concept in transthyretin amyloid cardiomyopathy.
Investors looking for midteen percentage weight loss findings in Zealand Pharma A/S’s phase II study of once-weekly amylin analogue petrelintide were clearly disappointed by the actual 10.7% mean body weight reduction, as shares (Copenhagen:ZEAL) fell 36% March 6. But from the company’s standpoint, the combination of efficacy and safety data from the Zupreme-1 study bode well for a phase III trial expected to start later this year.
In its fourth major biopharma deal since its 2019 founding, Repertoire Immune Medicines signed a partnership with Eli Lilly and Co. to develop tolerizing therapies for several autoimmune diseases, gaining an up-front payment of $85 million, with a potential $1.84 billion in development and commercial milestone payments coming later, along with tiered royalties.
The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
Offering $2.2 billion for Rapt Therapeutics Inc. and gaining its long-acting lead drug, ozureprubart, for food allergy and other indications, GSK plc is positioning itself to compete with market leader Xolair (omalizumab), developed by Roche AG’s Genentech unit and Novartis AG.
Siemens Healthineers AG became the latest company to sign a licensing agreement with Alzpath Inc. to use its pTau217 antibody in the development of a blood-based diagnostic assay for Alzheimer's disease. Alzpath previously signed deals with the likes of Roche AG and Beckman Coulter Diagnostics Inc. to use its pTau217 antibody to create diagnostic tests based for early detection and monitoring of Alzheimer's.
