Drugs

Don’t Approve Evolus Neurotoxin BLA: Medytox

South Korean biopharmaceutical company Medytox is petitioning FDA not to approve a Daewoong Pharmaceuticals neurotoxin product that is the subject of an Evolus BLA due to false statements about a botulinum toxin strain and concerns about data integrity and the impact on patient safety. In its petition, Medytox says that FDA should determine the true source and identity of the botulinum strain Daewoong is using to make its DWP-450 botulinum toxin product for Evolus. “Daewoong claims it found a one-of-a-kind botulinum strain called the ‘Hall strain’ in soil in South Korea,” the petition says. “Scientific evidence, however, shows this unique strain cannot be isolated from any soil.”

Medytox says that Daewoong is claiming that its product is made from the Clostridium botulinum toxin Type A Hall Strain, but also says it is a spore-forming C. botulinum strain actually isolated from soil in South Korea. The petition says that at least one of the claims must be untrue.

“Knowing the identity and source of the strain is essential to ensure the safety, purity, and effectiveness of a neurotoxin product,” Mydotex says. “A false statement about such a material fact calls into question the integrity of other statements and data showing safety and effectiveness in the BLA. In addition, the adequacy of the testing during manufacturing depends on the identity and characteristics of the strain.”

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