NICE has recommended funding for Nusinersen on the NHS. The recommendation was made for infants, children and adults with 5q spinal muscular atrophy and will be available through a scheme known as a Managed Access Agreement (MAA), meaning that patients will be able to get Nusinersen while more long-term data on its efficacy is gathered.
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Regulatory Professionals is one of the fastest growing global integrated regulatory outsourcing providers with a network of 20,000 pharmaceutical professionals globally. Working exclusively within the regulatory functions of Pharmaceutical, Biotechnology, Medical Device, Consumer health / OTC and Diagnostics industries.
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The European Commission has approved BioMarin’s Palynziq for the treatment of phenylketonuria (PKU) in patients aged 16 years or older. The governing body granted marketing authorisation at doses of up to 60 mg once daily, to reduce blood phenylalanine (Phe), which is an amino acid that is found in most forms of protein, concentrations in
AbbVie has announced that the European Commission (EC) has approved its interleukin-23 (IL-23) inhibitor Risankizumab, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. The EC gave approval following results from four Phase III studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance which assessed more than 2,000 patients