Approvals

Biotechnology company Recursion has been granted an Orphan Drug Designation for its potential treatment of the rare disease familial adenomatous polyposis (FAP).   FAP is a rare tumour syndrome in which hundreds or thousands of precancerous colorectal polyps grow in the body. As it stands there are no approved therapies for the disease.   Recursion’s therapy REC-4881 […]

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted Mundipharma and Cidara Therapeutics’ rezafungin Promising Innovative Medicine (PIM) designation for the treatment of invasive candidiasis. Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.  The criteria  For the MHRA to grant a PIM designation, medicinal […]

Angelini Pharma has announced that cenobamate, an oral anti-seizure medicine (ASM), is now available for use within NHS Scotland as a treatment for eligible adults with uncontrolled focal epilepsy. The Scottish Medicines Consortium (SMC) has accepted cenobamate for restricted use in adults with drug-resistant epilepsy as a second-line adjunctive ASM, after failure of the first […]

News round-up by DDW’s Megan Thomas for 14-18 February, 2022  This week, DDW rounds up updates, approvals, research and trials which will enable scientists to make life-saving developments in the drug discovery industry.  1. Trial launched of HIV vaccine antigens delivered through mRNA technology  IAVI and Moderna have dosed the first patients in a clinical […]

The National Institute for Health and Care Excellence (NICE) has updated Technology Appraisal Guidance (TAG) TA599 for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate [SZC]) in the treatment of adult patients with hyperkalaemia in England, Wales, and Northern Ireland.   Context   This guidance update follows the removal of the previous commercial arrangement, meaning that access to SZC for the treatment of persistent hyperkalaemia is […]