With key officials yet to be confirmed at the U.S. Department of Health and Human Services (HHS), the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee. Issued Jan. 21, the pause is in effect through Feb. 1. However, it’s unlikely that President Donald Trump’s nominees to head HHS and its agencies will be in place by then. The Senate Finance Committee will hold the first confirmation hearing Wednesday for Robert Kennedy, Trump’s pick for HHS secretary, with the Senate Health, Education, Labor and Pensions Committee holding a second hearing on his nomination the following day. Hearings have yet to be scheduled for Trump’s nominees to lead the various agencies in the department, including the CDC, CMS, FDA and NIH.

In a $1.64B deal, Neomorph and Abbvie will develop molecular glue degraders

Neomorph Inc. has signed another billion-dollar deal to develop molecular glue degraders (MGDs), this time with Abbvie Inc. Neomorph is receiving an undisclosed amount as an up-front payment and could receive as much as $1.64 billion in aggregate option fees and milestones plus tiered royalties on net sales. The collaboration and option-to-license deal involves developing MGDs for multiple targets in oncology and immunology. In October, privately held Neomorph reached an agreement with Biogen Inc. in a partnership worth up to $1.45 billion to develop MGDs targeting Alzheimer’s disease, and rare neurological and immunological diseases.

‘Exciting data’: S.Biomedics preps US IND of PD cell therapy

To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024. “Our data package of TED-A9, while pertaining to a small patient population, was greatly positive,” S.Biomedics CEO Tony Kang said during an interview with BioWorld. “It raises hope for a fundamental cure for the neurodegenerative condition that affects about 7 million patients worldwide.”

Study shows weight loss reduces spending; should GLP-1s be covered?

A study published in Jama Network Open in December indicated a direct correlation between adult weight loss and reduced health care spending, suggesting that current glucagon-like peptide-1 receptor antagonists (GLP-1RAs) should be reimbursed by Medicare and employer insurances for obesity and overweight conditions. Patient advocate Patty Nece has lost about 30% of her body weight by taking what she calls “life-changing” GLP-1 medications, but, she said during a Jan. 17 webinar sponsored by the international nonprofit organization Partnership to Fight Chronic Disease (PFCD), she has a friend with multiple myeloma who has received $1 million in treatment through Medicare. “She should’ve gotten that treatment, but we’re not sitting here saying, ‘Where’s the economic return on that investment?’ There is none. The return” is her better quality of life. “Why, when we’re talking about obesity, is that different?” When patients lose weight, the severity of other conditions, like pulmonary disease, congestive heart failure and depression, go down, said Ken Thorpe, an Emory University professor, the PFCD chair and a co-author on the study. A 5% reduction in body mass index generates a 6% reduction in spending, he said during the same webinar.

Aussie spinout could change blood pressure paradigm with low-dose poly pill

George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination. A polypill that combines multiple medicines into a single tablet, GMRx2 was developed out of a 20-year research program at The George Institute for Global Health. The single pill is a combination of three best-in-class medicines: telmisartan, amlodipine and indapamide. Each of the components are available at one-fourth of their standard dose, and the poly pill has the potential to be the only triple combination approved for the initial treatment of hypertension.

2024 closes with 228 US FDA approvals; December adds 19 drugs

The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in December, bringing the year's total to 49.

Also in the news

Altamira, Antennova, Artax, Belhaven, Bioxytran, Clearside, Coherus, Cosmos Health, Dermata, Ensysce, Hepion, Immunoprecise Antibodies, Immvention, Inhibrx, Life Molecular Imaging, Lisata, Maat, Novo Nordisk, Nurexone, Okyo, Oncolytics, Radiant, Recce, Salubris, Sanofi, Scilex, Sen-Jam, Urogen, Xilio, Tris