Gene Therapies Given Boost In NIH-FDA Partnership, New Aetna Network
Aetna's Gene-based Cellular and Other Innovative Therapies network is aimed at curbing million-dollar costs of the gene therapy market. Separately, the National Institutes of Health and the Food and Drug Administration launched a public-private partnership to speed up gene treatments.
Modern Healthcare:
Aetna To Cover Multi-Million Dollar Gene Therapies
Aetna debuted a network focused on curbing the rising costs of the growing gene therapy market, the insurer announced on Thursday. Structured like a Center of Excellence program, the company's Gene-based Cellular and Other Innovative Therapies network includes more than 75 providers who treat inherited retinal disease—which impacts approximately 2 million people worldwide—and spinal muscular atrophy, which impacts an estimated 9,000 Americans. Treatment for these conditions comes in the form of gene therapy, where providers manipulate genes at the cellular level. (Tepper, 10/27)
Stat:
Partnership Aims To Accelerate Gene Therapies For Rare Diseases
The National Institutes of Health and U.S. Food and Drug Administration unveiled a public-private partnership Wednesday aimed at accelerating gene therapies for the roughly 30 million Americans living with a rare genetic disease. “They’ve waited a long time for something to be focused this way to address the incredibly wrenching stories we see all around us of children and adults with rare diseases where we can do a diagnostic test to tell them what they have but beyond that haven’t had much to offer,” Francis Collins, the pioneering genetics researcher and longtime NIH director, told STAT. (Molteni, 10/27)
Stat:
The Vast Majority Of Genes Have Been Tied To Cancer, Complicating Research
João Pedro de Magalhães scours the human genome for clues that might help us understand why people age and what we might do to stop that. Without fail, each time he’s done one of these studies, nearly every gene ends up having some kind of link to cancer. “Always,” he said. “You always have some cancer-related genes in there.” (Chen, 10/27)
In other pharmaceutical industry news —
Stat:
Feds Probe Novartis Over Entresto Marketing And Compensation To Doctors
In what might become a new scandal for Novartis, federal investigators recently demanded information from the drug maker (NVS) about the pricing and marketing of one of its biggest-selling drugs, and the focus of the probe includes compensation paid to physicians. Last month, the U.S. Department of Justice issued a civil investigative demand about Entresto, a heart failure drug that generated $924 million in sales in the third quarter, a 46% gain. The demand was disclosed by the company in a regulatory filing, but further details were not made available (see page 36). (Silverman, 10/27)
Stat:
CytoDyn Knew Its FDA Application Was Incomplete When It Filed, Docs Show
CytoDyn and its CEO Nader Pourhassan have known the company’s long-delayed HIV drug was in far more trouble with the Food and Drug Administration than was disclosed to investors, according to new documents filed this week as part of an ongoing civil lawsuit. The documents reveal that in May 2020, CytoDyn submitted a marketing application for its drug called leronlimab with the FDA, despite knowing the filing was missing crucial information and was largely incomplete. (Feuerstein, 10/28)
