Nearly six weeks after Johnson & Johnson paused the U.S. external evaluation of its Varipulse pulsed field ablation catheter to investigate several neurovascular events in initial cases, the med-tech giant resumed its limited market release with revised global instructions for use.
The scientific establishment has launched a fight back against the Trump administration and the slew of executive orders that threaten to dismantle research funding, with a warning that the next month could be critical for the future of U.S. science.
Corbus Pharmaceuticals Inc. has placed its chips on “bets where somebody else is ahead of us,” CEO Yuval Cohen said. “The idea is to have a de-risked asset” that proves better in the clinic. At the 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco, Corbus offered data from the U.S. and U.K. first-in-human dose-escalation study – the Western trial – with Nectin-4-targeting antibody-drug conjugate (ADC) CRB-701 (SYS-6002).
Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
The scientific establishment has launched a fight back against the Trump administration and the slew of executive orders that threaten to dismantle research funding, with a warning that the next month could be critical for the future of U.S. science.
With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.
The U.S. Court of Appeals for the Federal Circuit occasionally remands a patent litigation case to district court for a variety of reasons, as seen in a decision involving Trudell Medical and D R Burton.
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.
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