Drugs

Changes Asked in Targeted Therapies Guidance

BIO says FDA should expand a draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease to provide further thinking on the agency’s receptivity to innovative approaches for developing targeted therapies. In its comment, BIO also recommends the draft guidance reflect a scenario in which one or more molecular alterations occur across multiple diseases.

In its comment letter, Pharmaceutical Research and Manufacturers of America reiterates the BIO request for a scenario of alterations across multiple diseases. The association also praises FDA for its efforts to advance development of targeted therapies in low-frequency molecular subsets of disease.

The National Organization for Rare Disorders voices support for several aspects of the draft guidance and lists additional areas in which the draft could be improved, including additional clarity on how best to extrapolate data from studies conducted before the current development pathway.

Merck asks FDA how strong the evidence from preliminary studies should be to support a grouping strategy. And it says the term “consistent” is used frequently in certain parts of the draft guidance but is not clearly defined, and guidance on criteria for establishing consistency would be helpful.

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