Today, a brief rundown of news involving Vertex Pharmaceuticals, the Food and Drug Administration and Merck & Co., as well as updates from Essa Pharma and Atara Biotherapeutics that you may have missed.
The National Health Service in England will now cover Vertex Pharmaceuticals’ newest cystic fibrosis medicine, Alyftrek, after a rapid review by U.K. drug cost regulators, who issued a positive draft recommendation. Alyftrek was approved in the country in March for use treating people 6 years or older who have cystic fibrosis and at least one type of mutation in a gene called CFTR. U.K. regulators secured an unspecified discount on Alyftrek, which in that country carries a list price of 16,110 pounds per 84-tablet pack of one dosage form or 56-tablet pack of another. The drug was authorized in the EU earlier this month for the same population, and Vertex expects that, as a result of agreements with Ireland, Denmark and Germany, patients living in those nations will also soon be able to access the drug. — Ned Pagliarulo
Food and Drug Administration Commissioner Martin Makary joined Vinay Prasad, who runs the agency’s biologics office, in writing a JAMA editorial published Monday that defends the regulator’s recent labeling change for messenger RNA-based COVID-19 vaccines. The FDA in June updated the shots’ safety information regarding the risk of myocarditis or pericarditis following vaccination. The editorial criticizes previous FDA and Centers for Disease Control and Prevention leadership for not issuing the warning sooner, and blames “broad” vaccine mandates for loss of trust in vaccines. Makary and Prasad recently made the FDA’s COVID vaccine approval standards stricter, forswearing further clearances in healthy adults on the basis of immune response data. — Ned Pagliarulo
Merck & Co. has started Phase 3 testing of an experimental once-monthly pill for HIV prevention. One study will test Merck’s MK-8527 in people with a greater likelihood of HIV-1 exposure in 16 countries and start enrolling participants in August. The other, being run with the help of the Gates Foundation, will evaluate Merck’s drug in women and adolescent girls in sub-Saharan Africa and begin recruitment in the next few months, Merck said Monday. The HIV pre-exposure prophylaxis, or “PrEP” market is currently dominated by pills, mostly taken daily, though Gilead Sciences recently won approval of a twice-yearly injectable medicine. — Ben Fidler
Struggling biotechnology company Essa Pharma is selling itself to XenoTherapeutics, a non-profit research foundation, in an all-cash deal. Essa, which has resisted investor pressure to shut down, said Monday that the deal will provide “more certain value to shareholders” faster than an outright liquidation. Stockholders are expected to receive $1.91 per share, as well as a contingent value right that could increase their payout by up to $0.06 per share within 18 months. Essa has been pursuing strategic alternatives since its top cancer drug failed a clinical trial last year. — Ben Fidler
Atara Biotherapeutics has resubmitted an FDA application for Ebvallo, a cell therapy it’s developing for a type of serious complication associated with transplant surgeries, the company said Monday. The agency in January rejected Atara’s request and, soon after, suspended multiple Atara studies due to compliance issues agency inspectors found at a third-party manufacturing site. Atara has since been cleared to resume testing and transferred all operational responsibilities involving Ebvallo, including manufacturing, to Pierre Fabre Laboratories. Atara remains the sponsor of the FDA application, though, and would receive a milestone payment and sales royalties if Ebvallo is approved. — Ben Fidler
