LONDON – France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has published draft guidelines on the cybersecurity of medical devices, becoming the first national regulator in Europe to specify what manufacturers should do to protect devices against malicious attacks.
DUBLIN – Every technology shift has its winners and losers. Ireland, long a key location for small-molecule and biologics manufacturing, is now gearing up to ensure it is on the right side of the divide as the rollout of cell and gene therapies (CAGT) gathers momentum. There are no guarantees that the same technological and economic factors that contributed to its success during earlier eras of pharmaceutical and biopharmaceutical manufacturing will apply to the coming era of regenerative medicine. But the country's inward investment agency, IDA Ireland, is betting that its long-established relationships with the top tier of biopharma companies and its longstanding expertise in meeting FDA manufacturing requirements will help in the battle to win new investment projects.
LONDON – Medicxi has closed a €400 million (US$449 million) third fund, bringing the amount raised by the venture capital firm since it split off from its parent Index Ventures three years ago, to more than $1 billion.
HONG KONG – Prestige Biopharma Pte. Ltd., a Singapore-headquartered pharmaceutical company under the Prestige Group, has agreed to grant exclusive license to U.K.-based multinational company Mundipharma International Ltd. for distribution and sale of its trastuzumab biosimilar, Tuznue, in western European markets, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.
LONDON - More than half of the 216 newly approved drugs reviewed by Germany's health technology assessment (HTA) agency between 2011 and 2017 did not have evidence to show they provided benefit over the existing standard of care.
DUBLIN – Biontech SE closed a mammoth $325 million series B round to fund expansion of its clinical pipeline and to continue its ongoing investments in several different areas of manufacturing. The scale of the deal is of historic proportions – it is the biggest private equity investment in any comparable European biotechnology firm. It just edges ahead of Oxford, U.K.-based Immunocore Ltd.'s $320 million investment in 2015.
DUBLIN – European biotechnology firms engaged in drug discovery and development raised an aggregate $3.172 billion in equity investment during the first half of 2019, down 19% on the same period last year. Unless there is a substantial pickup in the third and fourth quarters, the sector's record-breaking 2018 total of $7.715 billion looks to be out of reach.
LONDON – With five expensive advanced therapies recently approved in Europe and a further five expected to get approval in the near term, it is vital the hurdles that delay and preclude access – and which have led to the commercial failure of earlier products – are removed.
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