With a few tweaks to the protocol, Rocket Pharmaceuticals Inc.’s phase II trial testing RP-A501 in Danon disease is expected to resume following the lifting of the clinical hold, issued by the U.S. FDA in May in response to the death of a patient in the pivotal gene therapy study.
Celldex Therapeutics Inc. will not advance barzolvolimab (CDX-0159, barzo) in eosinophilic esophagitis (EoE) after taking a look at top-line data from the ongoing phase II effort. The study met its primary endpoint, proving barzo’s efficacy in depleting mast cells in the gastrointestinal (GI) tract, but this didn’t improve symptoms of EoE – a chronic inflammatory disease of the esophagus – which means mast cells are not a primary driver. Hampton, N.J.-based Celldex noted that barzo did turn up a favorable safety profile.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: BMS, Merck, Newamsterdam, Novo Nordisk, Soligenix, Springworks, Stealth, Systimmune, Tonix, Valneva.
Biopharma happenings, including deals and partnerships, and other news in brief: Astrazeneca, Boehringer, Fibrogen, Huadong, Lakeshore, Palatin, Vcare.
For more than 30 years, the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) worked together to harmonize their evidence-based vaccine schedules. Not anymore.
Avixgen Co. Ltd., a subsidiary of Dx&Vx Co. Ltd., inked a $360 million license agreement with an unidentified U.S.-based biotechnology company, granting the latter rights to its advanced cell penetrating (ACP) peptide drug delivery platform.
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