STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India
The U.K. government is being urged to scrap intellectual property demands in its trade negotiations with India, which critics say could threaten imports of cheap drugs.
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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.
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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