Drugs

Bill to Strengthen Biopharmaceutical Manufacturing

Sens. Chris Coons (D-DE) and Ted Budd (R-NC) have introduced the Biomanufacturing Excellence Act that they say would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing. A statement (includes links to the bill text and a one-page summary) from Coons says the legislation would establish the National Biopharmaceutical Manufacturing Center of Excellence, a public-private center dedicated to advancing biopharmaceutical manufacturing, which was a recommendation from a National Security Commission on Emerging Biotechnology report.

Coons says the center would:

unite industry professionals with academic researchers to conduct collaborative research on new technology for scaling biopharmaceutical manufacturing;
host a facility that replicates industrial manufacturing conditions and complies with FDA current good manufacturing practice regulations, where innovators would develop and test new manufacturing processes;
identify challenges and opportunities for scaling biopharmaceutical manufacturing, especially for products important to U.S. national security, public health, and economic security; and
train tomorrow’s biopharmaceutical manufacturing workforce by partnering with education, industry, and community leaders to bolster biotechnology talent.

Companion bipartisan, bicameral legislation has been introduced in the House.

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