Drugs

BIO Blasts USMCA Provision

BIO president Jim Greenwood is criticizing the Trump administration and House Speaker Nancy Pelosi for surrendering a “powerful tool for reining in foreign free riding.” In a statement on the apparent agreement on the USMCA trade pact with Mexico and Canada, Greenwood said the renegotiated pact eliminates provisions that prohibit foreign countries and foreign companies from stealing American medical innovation.

“President Trump has promised to end foreign free-riding on American medical innovation, but by removing enhanced IP (intellectual property) protections for biologic medicines, his administration just surrendered one of the most important tools that would stop it,” Greenwood said. “The administration and Speaker Pelosi have missed a critical opportunity to raise intellectual property standards in key markets, create good American jobs, and ensure that American biopharmaceutical companies have their ingenuity, innovation, and hard work protected around the globe. They have forsaken a sector in which America leads the world and which promises to be a key sector of our 21^st century economy.”

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