In opening today’s confirmation hearing for Susan Monarez who has been nominated to be the next U.S. CDC director, Sen. Bill Cassidy, R-La., noted that the CDC’s Advisory Committee for Immunization Practices (ACIP) was proceeding with its June meeting at that moment, despite the dismissal of all 17 members just two weeks ago. Given that there is no confirmed CDC director and a small newly appointed panel with many members lacking a broad vaccine or immunology knowledge, “there are concerns about the rushed nature of this process,” said Cassidy, who chairs the Senate Health, Education, Labor and Pensions Committee. At the same time, the newly minted ACIP chair, Martin Kulldorff, addressed some of those concerns as he opened the committee meeting. After thanking the former members, he insisted that the ACIP will make evidence-based recommendations built on the work already done by the panel’s work groups, which will remain intact.

Kymera brings on Gilead as partner while Sanofi alters deal

Kymera Therapeutics Inc. found itself juggling partnerships by bringing one on board while going to the development bench in another. Kymera and Gilead Sciences Inc. will collaborate on a molecular glue degrader program that targets cyclin-dependent kinase 2 in solid tumors, including breast cancer. The option and license agreement means Kymera could bring in up to $750 million, with as much as $85 million of it up front along with an option exercise payment. Also, Sanofi SA, in its five-year long partnership with Kymera, has decided an IRAK4 candidate has gone far enough and that it’s time to advance a different candidate.

Abion strikes $1.3B antibody drug deal with unidentified partner

Abion Inc. signed a potential $1.315 billion deal with an anonymous partner June 22, granting the counterparty exclusive global rights to a preclinical claudin 3 (CLDN3)-targeting monoclonal antibody, ABN-501, and the potential to license four more protein targeting antibodies. News of the deal, disclosed on the Korea Exchange June 24, sent Seoul, South Korea-based Abion shares (KOSDAQ:203400) up 55% over two consecutive days. Abion’s shares rose from ₩4,505 (US$3.31) June 23 to ₩7,600 June 25. Under the terms of the research collaboration and exclusive global license agreement, Abion will handle the preclinical study of the CLDN3 protein-targeting antibody as well as four other protein target antibodies.

Polyactiva raises $25M series C to advance US clinical programs 

Ophthalmology company Polyactiva Pty Ltd. closed a AU$40 million (US$25 million) series C round to advance late-stage clinical trials in the U.S. of its lead candidate, PA-5108, a biodegradable, sustained-release ocular implant that delivers latanoprost for reducing intraocular pressure (IOP) in patients with ocular hypertension and glaucoma. The series C round was led by an Australian sovereign wealth fund with continued support from Brandon Capital. 

Medibank first to cover psychedelic treatment in Australia

Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder (PTSD) offered through the Perth Clinic. The multiyear agreement marks the first major private health insurance funding of a psychotherapy-led PTSD program in Australia, and the move provides strong validation of Emyria’s Empax model, which integrates psychiatrist-supervised therapy, care coordination, and real-world data capture, Emyria Chief Operating Officer Mary-Ann Rennie told BioWorld.

Xlear presses court to force FTC to drop substantiation requirement

Xlear Inc., of Salt Lake City, has filed a petition in U.S. district court to force the Federal Trade Commission to cease a requirement found in the agency’s December 2022 health products compliance guidance. If the court finds for Xlear, the FTC will no longer be able to require manufacturers of health products to substantiate their claims with the backing of randomized, controlled trials, something the FDA itself does not require.

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