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The U.K. Medicines and Healthcare products Agency (MHRA) reported a trio of research projects as part of a push to maintain its reputation as a leading regulator of drugs and medical devices now the U.K. is no longer part of EU regulatory systems, and to attract clinical trials - and the associated inward investment - despite no longer offering access to the EU single market.
Numares Health AG received $21.2 million from the European Investment Bank (EIB) in support to its automated and software based IVD platform for obtaining high-quality nuclear magnetic resonance metabolomics data from blood or urine biopsy samples.
Although the war is still raging in Ukraine, Russia is marching forward with asserting its regulatory framework on health care in the parts of Ukraine it’s claiming as the spoils of the war it started 11 months ago.
It was a year of turmoil in Europe as Russia’s invasion of Ukraine and the fall-out from the COVID-19 pandemic shaped the fortunes of the life sciences industry in 2022. After years of tension, Russia’s attempt to annex Ukraine on Feb. 24 caused outrage and disruption and was unanimously opposed on humanitarian grounds by the life sciences and pharma industry.
Facing a 26.5% rebate on 2023 sales of branded prescription drugs in the U.K., the Association of the British Pharmaceutical Industry (ABPI) is seeking talks with the government early in the new year to develop a new biopharma settlement for the future that will reflect the potential of the life sciences sector to drive improvements in the health and economy of the U.K.
Seekin Inc.’s cancer mutation detection kit Pancanseek for leukemia patients has received a CE-IVD mark, expanding the company’s reach in the testing space.
Carmat SA just completed a flash fundraising of $33 million to increase production of its Aeson total artificial heart and support sales growth in Europe. The operation featured two distinct but concurrent actions: a reserved offer and a public offer. The reserved offer, intended for specialist investors, raised $28.9 million.
The European Union’s efforts to update its regulatory framework for medical devices was heralded as a long-overdue response to the Poly Implant Prothèse (PIP) breast implant scandal, but the COVID-19 pandemic added significant drag to the implementation timelines. Those timelines have proven impracticable for other reasons as well and the problem will bleed into the new year and perhaps beyond to the detriment of patients and manufacturers.
Earlysight SA is developing a novel ophthalmology device that can be used to diagnose certain degenerative eye disorders long before onset of first symptoms. Earlysight and researchers at the Swiss Federal Institute of Technology Lausanne (EPFL) have reported positive results for their first clinical trial of Cellularis in the journal Ophthalmology Science.
The U.K. is taking the next step in applying genomics to health care with the launch of a £105 million (US$130 million) project that will sequence the whole genomes of 100,000 healthy newborn babies to detect rare genetic conditions.
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