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.
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).
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.
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.
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.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alto, Anaptysbio, Aptose, Gensight, Inovio, Ocugen, Urogen.
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