Despite some concerns from a few members, the Advisory Committee on Immunization Practices unanimously approved recommendations to the CDC that boosters be made available to those wanting them. The advisory committee recommended that a single COVID-19 vaccine booster dose be given six months or more after completing an mRNA primary series in the same risk group for whom the CDC recommended a booster dose of Pfizer Inc-Biontech SA’s vaccine. The CDC presented data to the committee that the single mRNA COVID-19 vaccine dose be given to those age 65 and older, for those at least 18 years old and reside in long-term-care settings, and also for those ages 50 to 60 with certain underlying medical conditions. Read More
Sio Gene Therapies Inc. CEO Pavan Cheruvu said the company sees no “significant rate limiters to moving forward” with FDA fast-tracked AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. Shares of the New York-based firm (NASDAQ:SIOX) closed at $2.36, up 21 cents, as Wall Street welcomed positive interim data from the ongoing phase I/II study with the adeno-associated viral vector 9-based gene therapy for GM1 gangliosidosis. Read More
Shares of Ultimovacs ASA (OSE:ULTI) climbed 16.6% to NOK148.60 (US$17.82) on news the FDA will expedite an eventual review of its investigational cancer vaccine, UV-1, in combination with checkpoint inhibitors for the potential treatment of unresectable or metastatic melanoma. Read More
There’s a whole group of biotechs trying to create a tougher next-generation CAR T-cell therapy that could have a powerful effect on solid tumors after the technology’s first successes in blood cancer. One of those is London-based Leucid Bio Ltd., which has just raised £11.5 million (nearly US$16 million) in series A financing to develop next-generation CAR T therapies that are able to make it through to solid tumors and attack them. Read More
The push for legislation that would lower prescription drug prices in the U.S. has mounted in recent months, but support for Medicare pricing negotiations has faltered in the past few weeks. Sen. Bob Menendez (D-N.J.) is the latest Senate Democrat to signal his aversion to giving the government the authority to negotiate prices with drugmakers, breathing new life into hopes that the pharmaceutical industry will yet again escape a mechanism that critics say would suppress innovation at the expense of patients in desperate need of state-of-the-art therapies. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Algernon, Antengene, Aqilion, Atreca, Big Cypress, Cedilla, China Resources, Inovio, Legochem, Ligand, Logicbio, SAB. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akero, Beigene, Canbridge, Cstone, Esteve, Stealth, Vectivbio. Read More
