Drugs

Progress Being Made in Lung Cancer Therapies: Analysis

A study by the LUNGevity Foundation analyzing the current global lung cancer-focused drug development landscape highlights “the impressive progress that has been made in the lung cancer therapy space and points to an increased need for comprehensive biomarker testing at earlier stages of the disease.” The foundation says the majority of the therapeutic entities the study identified are focused on non-small-cell lung cancer and are in the clinical trial stage of development.

The report found that new treatment approaches are being developed and tested for both non-small cell and small cell lung cancer, including new classes of drugs such as protein degraders. “The analysis also indicates that lung cancer treatment will become increasingly biomarker-driven, even for immunotherapy regimens,” the foundation says. “Also, as more targeted therapies and immunotherapies are being developed for early-stage lung cancer, there will be a need for biomarker testing to be implemented at earlier stages of the disease.”

The foundation cautions that as targeted therapies continue to be developed, it is important to consider whether there will be enough patients to fill clinical trial recruitment needs and whether there will be oversaturation in the market.

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