Scientists in the U.K. have reacted with dismay to the announcement that the National Cancer Research Institute (NCRI) is to close, 22 years after it was set up to coordinate the efforts of industry, government research agencies and medical charities that sponsor and fund clinical trials.
The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System.
The imaging and advanced guidance for workflow optimization in interventional oncology consortium (IMAGIO) consortium of clinical partners in the EU, led by Royal Philips NV, has been awarded $26 million under the Innovative Health Initiative (IHI) to carry out research into less invasive cancer therapies.
Stephanix SAS and Incepto Medical SAS reported signing a strategic partnership at the annual congress of the French association for female medical imaging (SIFEM) in Bordeaux. The companies are joining forces by way of a distribution agreement to improve the medical imaging available in France.
The U.K. Medicine and Healthcare Products Regulatory Agency (MHRA) has moved to incorporate the Global Medical Device Nomenclature (GMDN) system into its device registration database, a development that will ease the task of providing postmarket surveillance for these products. However, the change may also take some of the noise out of the registration process in the U.K. market, thanks to the standardization of information the GMDN represents.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
Radiotherapy fractionation has had a significant impact on the morbidity associated with the procedure across a number of cancer types, and the U.K. National Institute for Health and Care Excellence (NICE) says it may be time to fractionate further for some breast cancer patients.
Could a bioactive peptide secreted in the saliva of ticks offer a useful therapy for people who have experienced intracerebral hemorrhage (ICH)? That’s the question Bioxodes SA has set out to answer, and the company is about to move its first-in-class drug candidate, Ir-CPI, which has dual anti-thrombotic and anti-inflammatory effects, into a phase IIa trial in patients with ICH.
In a move that saw shares tumble by 26%, Biosenic SA has halted a phase IIb trial for its allogeneic stem cell therapy, Allob, after it failed to accelerate healing when given to patients two days after they sustained tibial fractures. The company plans to shift its focus to its late-stage arsenic trioxide candidate for chronic graft-vs.-host disease (GVHD).
Artificial intelligence (AI) faces a number of interesting hurdles in the EU, such as the still-developing Artificial Intelligence Act (AI Act), which seems destined to treat health care uses as high-risk propositions. Corinne Dive-Reclus, director of global lab insights at Roche Diagnostics, said there are possible solutions, such as overwriting the AI Act’s risk classifications with the risk category provided by existing regulations, but there is an open question as to whether a fix will be in place to prevent a potentially disastrous risk framework for AI in health care.
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