Approvals
- In the US, the FDA has approved the first generic competitor to Mylan’s EpiPen and EpiPen Jr (epinephrine) for the emergency treatment of allergic reactions. The generic version is made by Teva Pharmaceuticals and will be available in 0.3 mg and 0.15 mg strengths. No pricing details have yet been announced, which will be of high interest given last year’s outcry over EpiPen price increases.
- Both the FDA and the European Commission have approved Onpattro (patisiran) – the first in a new class of drugs called siRNAs, which work by silencing a portion of RNA involved in disease. Onpattro is approved to treat hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. Onpattro encases the siRNA into a lipid nanoparticle to deliver the drug directly into the liver, in an infusion treatment.
- Gilead’s CAR-T therapy has been approved in the European Union, but only a day later it was rejected by the UK’s cost watchdog, the National Institute for Health and Care Excellence, because of the high (undisclosed) price tag. “Although promising, there is still much more we need to know about CAR-T, and unfortunately, in this case, we are not able to recommend axicabtagene ciloleucel for use in the NHS in England at the cost per patient,” Meindert Boysen, director of the center for health technology evaluation at NICE, said in a statement.
Regulation
- Pfizer is seeking guidance from the FDA for information dissemination about biosimilars. Specifically, the company wants to know what originator companies can and can’t say about biosimilar versions of their products. The company has submitted a citizen’s petition to the FDA and also calls out companies for using “scare tactics” to undermine biosimilars.
- The UK’s Department of Health and Social Care has released several Technical notices about planning for a potential no-deal Brexit, including information about how medicines, medical devices and clinical trials will be regulated, submitting regulatory information on medical products and batch testing.
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