Drugs

Stakeholders Suggest Changes to Ulcerative Colitis Drug Guidance

Five major drug companies have commented on and suggested changes to an FDA draft guidance on developing drugs to treat ulcerative colitis. Novartis says it finds the draft to be clear and helpful for the future development of drugs to treat ulcerative colitis and recommends some changes that may further help the development of new medicines for this indication.

Gilead Sciences provides line-by-line comments and recommendations.

Genentech says it believes the draft “will help us optimize drug development for patients with ulcerative colitis.” The company says it wants to understand the extent to which results from clinical trials can be leveraged. “Specifically,” it says, “we would like guidance on whether and how extrapolation can be applied for special populations and combined with expanded enrollment opportunities to allow for therapeutic development.”

AstraZeneca comments that the guidance “addresses well key features including trial population, trial design, efficacy considerations, and safety assessments for clinical trials.” It seeks some clarifications and proposes some changes.

Finally, Pfizer 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

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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