Drugs

Tvardi Therapeutics Orphan Status for Pulmonary Fibrosis Drug

FDA has granted Tvardi Therapeutics an orphan drug designation for TTI-101 for treating idiopathic pulmonary fibrosis (IPF). TTI-101 is described as an orally-delivered, small molecule, direct STAT3 inhibitor. “STAT3 has emerged as a central node of fibrosis and has been found to accumulate in the fibrotic lungs of IPF patients,” the company says. “STAT3 plays a major role in many of the cellular processes that drive the development and progression of fibrosis including clotting and coagulation, inflammatory cell migration, fibroblast proliferation, and extra-cellular matrix deposition.”

The therapy is currently being evaluated in a Phase 1 single agent multicenter clinical trial in patients with advanced solid tumors. The study has shown that TTI-101 is well tolerated and has clinical activity across a broad range of tumors, Tvardi says, adding that pre-clinical studies have also demonstrated that STAT3 inhibition with TTI-101 reverses fibrosis and restores lung function in IPF models.

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