As new clinical trials regulations were signed into law in the U.K., an analysis of 4,616 submissions to conduct studies has highlighted what is required for the updated law to translate into a more efficient, streamlined and adaptable regulatory framework.
Two days after pharma companies sounded an alarm that their investments were headed out of Europe, Novartis AG has announced plans to increase investment in the U.S. by $23 billion, bringing the total it invests over the next five years to nearly $50 billion.
U.K. scientists developed a saliva-based test which better predicts the risk of prostate cancer than current prostate-specific antigen (PSA) blood tests by analyzing DNA to look for genetic variants linked to prostate cancer and calculating a polygenic risk score.
The U.K. government is to invest £500 million (US$645 million) in a health data research service that will provide a single point of access to national-scale anonymized patient records, ending the need to navigate different systems or make multiple applications to use information.
Medicud Srl received over €1.3 million (US$1.4 million) in seed funding to support clinical trials and secure regulatory approval of Dryum, its incisional negative pressure wound therapy system.
The EU’s Medical Devices Coordination Group (MDCG) issued another revision of its guidance for risk classification for in vitro diagnostics — the fourth such rewrite of a guidance that came out in 2020.
The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.
In the wake of the pandemic, many leading med-tech companies took steps to on-shore and near-shore manufacturing, a move that could protect significant numbers of players from the worst of the effects of the tariffs announced by the Trump administration last week.
Med tech and diagnostic companies in Europe are considering strategies to navigate the U.S. market following President Trump’s introduction of reciprocal tariffs on imports. While some companies are more exposed than others, there’s no doubt that many will feel the pain.
ABL Bio Inc. announced April 7 that it sealed a potential £2.075 billion (US$2.65 billion) license deal with GSK plc, granting GSK global rights to use ABL’s blood-brain barrier (BBB) penetrating bispecific antibody platform, Grabody-B, to develop multiple programs in the neurodegenerative disease arena. Under the terms signed April 5, ABL agreed to transfer Grabody-B-related technology and know-how to GSK, upon which GSK will assume responsibility for preclinical and clinical development, manufacturing and commercialization.
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