Drugs

Doctors Favor Biologic Name Suffixes: Poll

A poll of doctors conducted by the Biologics Prescribers Collaborative, a project of the Alliance for Patient Access, on FDA’s proposed biosimilar naming guidelines, found that 80% of the respondents across multiple medical specialties preferred a meaningful four-letter suffix that noted the biosimilar manufacturer’s name, rather than a random four-letter suffix. Only 8% of those surveyed preferred a suffix with no meaning, while 12% had no preference.

Some 53% of the doctors said they would feel more confident prescribing a biosimilar if the product name contained a meaningful suffix, while 7% said they would feel more confident with a suffix devoid of meaning, while 39% said it would have no impact on their confidence prescribing biosimilar products.

More than two-thirds of the doctors were also interested in learning more about biosimilar clinical trial data.

The collaborative says that FDA hasn’t issued final guidance on naming conventions and at different times has endorsed random or memorable suffix systems.

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