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. Read More
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. Read More
Ligachem Biosciences Inc. landed another exclusive licensing deal to develop and commercialize antibody-drug conjugates (ADCs), this time with T-cell receptor therapy specialist Daan Biotherapeutics Inc. for a cancer-targeting antibody. Read More
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. Read More
While first-generation glucagon-like peptide-1 receptor agonists have clearly taken the obesity market by storm, generating billions of dollars for Novo Nordisk A/S and Eli Lilly and Co., several other companies are developing follow-on products that could clean up the tolerability and adherence issues of Wegovy (semaglutide) and Zepbound (tirzepatide). Read More
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 (F18-Pivalate) successfully detected brain metastases in a variety of primary solid tumors in a phase II study. Read More
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. Read More
With the first company in the world announcing more than $1 billion in annual revenue from pulsed field ablation on Feb. 5, Clarivate plc and BioWorld MedTech’s latest report provides well-timed insight into the stunning growth and bright future of this new medical technology for the treatment of atrial fibrillation. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alto, Anaptysbio, Aptose, Gensight, Inovio, Ocugen, Urogen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Crispr, Hefei Tianhui, Kenai, Merck, Neuphoria, Nkure, Octavian, Oramed, Oratech, Statera, Tivic Health. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Crispr, Hefei Tianhui, Kenai, Merck, Neuphoria, Nkure, Octavian, Oramed, Oratech, Statera, Tivic Health. Read More
