“Do not take us backwards,” many doctors and other stakeholders implored the CDC’s Advisory Committee for Immunization Practices ahead of its meeting that starts Dec. 4 with a day-long discussion and votes on whether the current recommended birth dose of the hepatitis B virus vaccine should be delayed.
Shares of San Diego-based Capricor Therapeutics Inc. (NASDAQ: CAPR) closed Dec. 3 at $29.96, up $23.60, or 371%, as investors cheered top-line data from the pivotal phase III Hope-3 trial testing cell therapy deramiocel in Duchenne muscular dystrophy.
Australian researchers have found a drug combination that can bypass the cellular defenses in neuroblastoma that lead to relapse, and the discovery could lead to better treatment strategies for children whose cancers have stopped responding to standard chemotherapy.
So much for stability at the U.S. FDA. Three weeks after accepting the position as director of the FDA’s CDER, Richard Pazdur has informed the agency of his intention to retire at the end of the year.
The next stop on the comeback tour for the U.S. FDA’s Rare Pediatric Disease Priority Review Voucher program is the Senate, after the House unanimously passed the Mikaela Naylon Give Kids a Chance Act, H.R. 1262, Dec. 1.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, Celltrion, Cullinan, Eisai, Iaso, Innovent, Ionis, Johnson, Kedrion, Mannkind, Medivir, Merck, Sound, Vanda.
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