Drugs

Brain Cancer Breakthrough Using Polio Virus: 60 Minutes

FDA this week granted breakthrough therapy status to a Duke University-based company’s new therapy that cured recurrent brain gioblastoma in three patients and extended life for others in a clinical trial from 10 to 15 months, according to a CBS 60 Minutes report to be aired Sunday and previewed on CBS Evening News 5/12. Duke is the home of FDA commissioner Robert Califf, whose connection, if any, to the development was not mentioned. CBS anchor Scott Pelley said 60 Minutes has been following the Duke cancer study with the re-engineered polio virus for two years.

The broadcast said the re-engineered virus is the creation of Duke molecular biologist Mathias Gromeier, now an investor in the developing company, who had removed a key genetic sequence in the original virus. “The virus can’t survive this way, so he repaired the damage with a harmless bit of cold virus,” Pelley reported. “This new modified polio virus can’t cause paralysis or death because it can’t reproduce in normal cells.

“But it can reproduce in cancer cells, and in the process of replicating, it releases toxins that poison the cell. This process also awakens the immune system to the cancer it never noticed before.” Gromeier told Pelley his process removed a protective shield than all human cancers develop to make themselves invisible to the immune system.

“It appears,” Pelley summarized, that “the polio starts the killing, but the immune system does most of the damage.”

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