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 new feature allows users to see their cholesterol trends over time. They can input their readings from clinics and labs in one place, schedule appointments and receive digital coaching to make improvements.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The FDA approved Nexlizet, according to an entry in its database of approved drugs. The new drug combines the active ingredient of Nexletol - which the FDA approved last week - with a generic non-statin drug, ezetimibe.
The drug, Nexletol, is designed for use with maximally tolerated statins for lowering LDL cholesterol in patients with heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease.
The deal will make the Phase III drug inclisiran - which Novartis acquired when it bought The Medicines Company in November - available to patients in the U.K. and include manufacturing and clinical development efforts.
Although it hasn't yet released details, the company announced positive data from two Phase III studies of inclisiran, which it is developing with Alnylam. The drug prevents production of PCSK9, the target of drugs made by Amgen and Sanofi/Regeneron.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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.
The decision was a loss for Amgen, which had claimed that Sanofi and Regeneron's drug Praluent infringed on its patents for the drug Repatha.
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.