Drug stocks initially jumped after Donald Trump was elected, on the bet the new president would support the industry’s profits. Then they stumbled, as Trump publicly criticized high drug prices and the debate on the future of healthcare shifted by the day, or even the hour....
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The US Food and Drug Administration (FDA) has extended the indication for Vertex Pharmaceuticals Symdeko (tezacaftor/ivacaftor) for the treatment of pediatric patients ages six years and older with cystic fibrosis who have certain genetic mutations. The approval comes after the FDA last year approved Symdeko to treat patients ages 12 and older who had the same specific genetic mutations. The initial FDA approval was based on three phase III, double blind, placebo-controlled trials, which demonst...
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Blackstone Life Sciences, a private investment firm, along with Novartis, launched Anthos Therapeutics with a $250 million investment. Anthos will be headquartered in Cambridge, Mass. As part of the deal, Anthos licensed MAA868 from Novartis. MAA868 is an antibody directed at Factor XI and XIa, both components of the intrinsic coagulation pathway. The compound has the potential to prevent a range of cardiovascular disorders involved in blood clotting, and which the companies believe will have si...
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After a year of negotiations, NICE has confirmed that it is still unable to recommend Biomarin’s Batten disease drug, saying that the company is unable to address concerns about long-term effectiveness. Brineura (cerliponase alfa) is designed to treat children with Batten disease, also known as neuronal ceroid lipofuscinosis type 2 (CLN2) – a very rare inherited condition affecting between one and six babies each year in the UK. In its earlier draft guidance, published last year, NIC...
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Martindale Pharma is a UK-based specialty pharmaceutical company providing essential medicines to over 50 countries around the world. They specialise in the field of opioid addiction, emergency care and sterile injectables....
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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced its latest meeting highlights, including a restriction of the use of Xeljanz (tofacitinib), and a call for withdrawal of marketing authorisations for fenspiride medicines. The Xeljanz restriction comes as the organisation has started a new review of the drug, and has recommended, as a temporary measure during the review, that doctors must not prescribe the 10 mg twice-daily dose of this m...
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