Drugs

Comments on Immune-Mediated Adverse Reaction Guidance

Responding to an FDA draft guidance on characterizing, collecting, and reporting immune-mediated adverse reactions in cancer immunotherapeutic clinical trials, Bristol-Myers Squibb says it is expected that as new traditions and times of therapy are developed, a better understanding within the healthcare community and the sponsor’s database/experience continue to expand. “Collecting and reporting of immune-mediated adverse reactions are expected to evolve over time,” the company letter says. “Therefore, BMS proposes that this guidance provide recommendations to sponsors on their expectations to collecting and reporting immune-mediated adverse reactions beyond the first approval.”

In its comment, Pfizer recommends that FDA consider transitioning away from the classification of adverse events as immune-mediated adverse reactions given the challenges in making such a determination in many cases. The company also includes specific line-by-line comments.

Boehringer Ingelheim provides line-by-line comments.

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

Read more

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