BioSpace News Archive

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Kaiser Permanente has announced Paul Minardi, MD, as executive vice president and chief executive officer of the KP Medical Foundation — the nonprofit organization created to organize expertise, systems, resources, and standards to manage ambulatory care operations in Kaiser Permanente’s Colorado and Washington state markets.

Shanghai Henlius Biotech, Inc. announced that the first patient was dosed in NCT05468489, a bridging head-to-head trial in the United States comparing HANSIZHUANG, an innovative anti-PD-1 monoclonal antibody independently developed by the company to standard of care Atezolizumab.

Eisai Co., Ltd. and Biogen Inc. announced that the results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical study of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD with confirmed presence of amyloid pathology in the brain, were published in the New England Journal of Medicine, one of the world’s most prestigious peer-reviewed medical journals.

BioArctic AB’s partner Eisai announced that the results from the large global Phase 3 confirmatory Clarity AD clinical study of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer’s Disease conference, in San Francisco, California and virtually.

X4 Pharmaceuticals (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with diseases of the immune system, today announced positive top-line results from the global, pivotal Phase 3 clinical trial (4WHIM) of its lead investigational therapy, mavorixafor, a novel CXCR4 antagonist, in people with WHIM syndrome.

Voyager Therapeutics, Inc. has entered into an employment agreement with a newly hired employee that, among other things, provides for the grant to such employee of a non-qualified stock option and restricted stock units as an inducement material to such employee’s entering into employment with Voyager.

TFF Pharmaceuticals, Inc. announced the closing of its previously announced underwritten offering of 10,675,001 shares of its common stock and warrants to purchase up to 5,337,501 shares of common stock.

MDxHealth SA, a commercial-stage precision diagnostics company, provided clinical and reimbursement product developments, updated guidance for 2022, and initial guidance for 2023.

Evolent Health, Inc. announced that Chief Executive Officer Seth Blackley, Chief Financial Officer John Johnson and Vice President, Investor Relations Seth Frank will participate in upcoming investor conferences.