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Latest From Ian Schofield
A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.
A coalition of life sciences industry bodies has written a position paper outlining its concerns about Brexit in areas such as EU free trade deals, customs declarations and tariff barriers.
Nearly 18 months after the UK voted to leave the European Union, pharmaceutical companies and regulators are still in the dark as to what kind of regulatory arrangements will exist between the two parties after Brexit takes place in March 2019.
Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.
UK HTA body NICE has rejected an appeal against its July decision not to recommend the use of Orexigen’s obesity drug Mysimba in England.
A report from the Office of Health Economics in the UK has quantified the potential levels of drug shortages and delays in new product launches and the sharing of safety information if the country leaves the EU without comprehensive free trade or mutual recognition deals.