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A Food and Drug Administration panel decided that Vertex Pharmaceuticals and CRISPR Therapeutics could assess potential safety risks of their sickle cell disease gene therapy after approval, Reuters writes. If the therapy is approved, Vertex has proposed a 15-year follow up of patients to evaluate the safety outcomes of the therapy. The panel said the 15-year follow up will help generate data from real-time monitoring of the therapy, which uses the new gene editing CRISPR technology. FDA staff said the new type of technology raised concerns about unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about efficacy. Read STAT’s live blog of yesterday’s advisory committee meeting here.
As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues the agency should factor in controversial patent maneuvers for one drug that will have cost the program nearly $2 billion in additional spending by 2026, STAT writes. At issue is the Enbrel medication sold by Amgen for treating rheumatoid arthritis and other ailments. The drug was one of 10 selected by Medicare officials for price negotiations, which are designed to create so-called maximum fair prices that will go into effect in three years. But Public Citizen maintains Medicare officials should consider the ongoing cost of the patenting tactics when negotiating a price.
The FDA approved Amgen’s biosimilar version of Johnson & Johnson’s blockbuster psoriasis treatment, Stelara, for multiple inflammatory diseases, Reuters says. The agency noted that the Amgen treatment will be interchangeable, which means it can be substituted for the brand-name drug without consulting a doctor, and touted a commitment to promoting competition. However, the Amgen drug is not expected to launch until 2025 as part of a legal settlement between the two companies earlier this year to delay the entry of the therapy. Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 billion in 2022.
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