A 15% cap on indirect cost reimbursement that was announced by the U.S. NIH has been stalled by a court order for the time being. But researchers remain deeply concerned about the attempt, and about the new administration’s adversarial approach to research and universities.
Pliant Therapeutics Inc., which offered few details earlier this week when it voluntarily paused enrollment in the phase IIb Beacon-IPF trial testing bexotegrast in idiopathic pulmonary fibrosis (IPF), has taken an unusual step as it assembles a panel of outside experts to review unblinded data from the study with the goal of providing an independent recommendation.
The market took a strong liking to the latest U.S. FDA guidance for Moleculin Biotech Inc.’s upcoming Miracle phase III trial testing annamycin in cancer. So much so that the company’s stock (NASDAQ:MBRX) soared 202% on Feb. 13 to close at $1.27 a share.
Coming as no surprise, the U.S. Senate’s Feb. 13 confirmation of Robert Kennedy as the next secretary of the Department of Health and Human Services (HHS) did nothing to ease the uncertainty hanging over the FDA and other HHS agencies.
Dealmaking in the Asia Pacific (APAC) region took off this week, with the latest showcasing Genome & Co.’s licensing deal with Ellipses Pharma Ltd. for GENA-104, a phase I-ready immuno-oncology asset, under undisclosed terms Feb. 11.
Biomissile Pharmaceuticals Co. Ltd. is developing multispecific antibodies that overcome resistance associated with antibody-drug conjugates via its next-generation natural killer (NK) cell engagers. “ADCs are very efficacious, but they do have a drawback with side effects and resistance, because ultimately ADCs are similar to chemotherapy because you bring toxins to the tumor site,” Biomissile co-founder and CEO Chao Tu told BioWorld.
Xilio Therapeutics Inc. is banking $52 million up front from Abbvie Inc., including a $10 million equity investment, plus about $2.1 billion in contingent payments for option-related fees and milestones, plus tiered royalties, as the pair embarks on developing tumor-activated, antibody-based immunotherapies, including masked T-cell engagers.
Edwards Lifesciences Corp.’s posted fourth quarter results slightly ahead of expectations, but indicated that the first quarter of 2025 might not be as bright. The company expects growth for both its lead transcatheter aortic valve replacement (TAVR) business and the company to fall below its full-year estimates, with a mid-year indication expansion for TAVR providing a critical boost in the back half of 2025.
A recent patent application from Laleh Rad, associate professor of Biomedical Engineering and Radiology at Northwestern University, describes the use of machine learning for real-time risk assessment of magnetic resonance imaging in patients with conductive implants for whom tissue heating from radiofrequency excitation fields remains a major concern.
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