The FDA placed a clinical hold on Verve Therapeutics’ application to begin human testing of its gene-editing therapy for an inherited form of high cholesterol. No details about the FDA’s questions or concerns were disclosed; so far, no serious safety problems have been reported in the U.K. and New Zealand where the clinical trial is already underway.
The deal was originally announced in November. The Medicines Co.'s lead product candidate is inclisiran, an RNAi drug for reducing cholesterol, for which it submitted an FDA approval application in December.
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The biotech company had kept the drug available at the higher list price in order to give payers and pharmacy benefit managers time to adjust contracts and minimize supply chain disruptions.
Inclisiran, which The Medicines Co. is developing with Alnylam, prevents production of PCSK9, the same protein targeted by two drugs that were the subject of a major patent lawsuit ruling last week. The company plans regulatory filings starting later this year.
Equity research analysts wrote in a note Thursday that the move could have a beneficial read-across to another drug that has the same target as Repatha.
Pfizer is launching a new, competitive grant program that solicits research projects on the gene PCSK9’s role in cardiovascular disease. It marks yet another step in big pharma’s goal to directly plumb academia for insights on their own drug targets. The grant program, through Pfizer’s Aspire initiative (Advancing Science through Pfizer Investigator Research Exchange), will fund grants up […]
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.