Drugs

Keros Halts Some Dosing in Cibotercept Trial

Keros Therapeutics has halted some dosing in a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension (PAH) due to unexpected adverse events. The decision to stop dosing 3mg/kg and 4.5mg/kg treatment arms in the ongoing TROPOS trial comes after a safety review due to the “unanticipated observation of pericardial effusion adverse events in the trial,” the company says.

“We are working diligently to gain a better understanding of these unanticipated findings,” the company says, adding that it discussing the findings with FDA and other regulatory authorities. “The TROPOS trial is fully enrolled, and dosing in the 1.5 mg/kg treatment arm remains ongoing following completion of a risk and benefit assessment of the data from the ongoing trial that was conducted by the independent Data Monitoring Committee followed by a select group of unblinded individuals at Keros,” it says.

Cibotercept is described as being designed to bind to and inhibit the signaling of TGF-β ligands that stimulate smooth muscle hypertrophy and fibrosis, including activin A, activin B and myostatin. Keros believes the drug has the potential to increase the signaling of bone morphogenic protein (BMP) pathways through this inhibition to treat diseases such as PAH that are associated with reduced BMP signaling.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome