Drugs

Orphan Status for Novita Pancreatic Cancer Drug

FDA has granted Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044. Novita says the designation covers the use of NP-G2-044 in pancreatic cancer, including in combination with immune checkpoint inhibitor therapies.

“This represents an important regulatory milestone for Novita and validates our scientific and clinical approach,” Novita CEO Stewart Campbell is quoted in a release as saying. He added that targeting fascin offers a novel strategy to enhance anti-tumor immune activity and potentially improve outcomes in a disease that has seen little therapeutic progress for decades.

Fascin plays a key role in tumor cell motility and metastasis, which accounts for the vast majority of cancer-related deaths. Novita says it is developing fascin inhibitors as a way to both block the spread of cancer and potentially improve responses to immuno-oncology therapies, which fail to benefit many patients.

NP-G2-044 is currently being studied in a multicenter Phase 2 trial evaluating the drug as both a monotherapy and in combination therapy in patients with advanced or metastatic solid tumors.

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