Drugs

Operation Warp Speed Invests in Merck Covid Drug

HHS and the Defense Department have signed a $356 million contract with Merck for between 60,000 and 100,000 doses of its MK-7110, an immune system modifying antibody that the company recently acquired in its buyout of OncoImmune. The doses would be produced by this June. The administration is betting on results from one late-stage trial suggesting that the drug could drastically improve patients’ chances of recovering from severe Covid-19, according to an Endpoints News report.

The story says MK-7110 was shown to reduce the risk of respiratory failure or death by 50% in a trial of 203 late-stage Covid-19 patients. It also reportedly gave patients 60% odds of improving.

Endpoints says the results make the drug appear as good or better at helping severe patients than dexamethasone, the generic steroid that has been the only drug shown to improve mortality in Covid-19 patients. The two drugs employ different mechanisms to modulate patients’ immune systems, the report says.

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