Drugs

Pilatus Wins Fast Track for Liver Cancer Therapy

FDA has granted Pilatus Biosciences a fast-track designation for its lead drug candidate, PLT012, for treating hepatocellular carcinoma (HCC). PLT012 is described as a first-in-class monoclonal antibody designed to inhibit CD36, a lipid transporter implicated in metabolic immune suppression within the tumor microenvironment. CD36 is expressed on exhausted T cells, natural killer cells, regulatory T cells, and tumor-associated macrophages. By inhibiting this pathway, the antibody can reduce immunosuppressive cell populations and reinvigorate innate and adaptive anti-tumor responses.

In preclinical models, the company says PLT012 demonstrated monotherapy activity in both immune-inflamed and immune-excluded tumors, and showed potential synergy when combined with PD-1/PD-L1 checkpoint inhibitors. Those findings support development as both a standalone therapy and in combination regimens, it adds.

Beyond oncology, Pilatus says it is exploring the antibody’s potential in metabolic dysfunction-associated steatohepatitis (MASH), a liver disease that can progress to cirrhosis and HCC. By targeting CD36-driven lipid uptake, PLT012 has shown reductions in inflammation and fibrosis in preclinical models of MASH, according to the company.

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