Drugs

FDA Hits Nascent Biotech on Drug Promotion

FDA has sent Nascent Biotech an untitled letter objecting to promotional content on the company’s Web site about its investigational drug pritumumab. The letter says that discussing the drug’s safety and effectiveness for the purpose for which it is being investigated misbrands the product.

FDA says the Web site describes the use of pritumumab for treating brain cancer. The site includes claims and presentations, such as: “Pritumumab has cured a rare form of brain cancer;” and “After five years, patients treated with pritumumab have an overall survival rate of 25-30%, compared to 3% standard therapy, demonstrating antibodies are safe and effective.” The agency says that because pritumumab is an investigational new drug, the product’s indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. “These claims and presentations are extremely concerning given the lack of adequate safety and efficacy data for pritumumab,” the letter says.

FDA told the company to stop violating agency regulation by promoting the unapproved investigational drug.

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