With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
The U.K. National Institute for Health and Care Excellence said its review of the Prontosan line of wound care products by B. Braun Medical AG of Melsungen, Germany, may be a cost saver for the National Health System compared to saline flush for chronic wounds. However, the agency also noted that most of the evidence of the effectiveness is of “not good quality,” suggesting that the company conduct more clinical trials to cover the evidence gap.
Leading clinicians in the U.K. have set out a blueprint for integrating pharmacogenomic testing into prescribing in all cases where there is a known association between a gene variant and how an individual will respond – or not – to a particular drug.
LONDON – A U.K. trial has shown it is possible to seamlessly insert point-of-care genotype testing for a rare genetic variant that causes hearing loss into the current care pathway in neonatal treatment for sepsis.
Astrazeneca plc is selling its disease management platform Amaze to U.K. digital therapeutics company Huma Therapeutics Ltd. through a new collaboration agreement. The companies said they will work together to launch Software as a Medical Device (SaMD) companion apps for several therapeutic areas and accelerate adoption of decentralized clinical trials (DCTs). The partnership marks Astrazeneca’s first major deal in the digital health space.
Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access.
Clinical researchers from Karl Landsteiner University in Krems, Austria, have been conducting a prospective study of a new diagnostic technique for bronchoscopy tissue sampling aimed at patients with unclear diffuse parenchymal disease. They have assessed morbidity and 30-day and 90-day mortality following transbronchial lung cryobiopsy. The team recently published their findings in Therapeutic Advances in Respiratory Disease.
At the AD/PD 2022 international conference on Alzheimer’s and Parkinson’s Diseases, AC Immune SA presented images showing its positron emission tomography (PET) tracer detecting pathological alpha-synuclein (a-syn) in human subjects’ brains. The abnormal accumulation of a-syn, a natively unfolded and soluble presynaptic protein, is a neuropathological feature of neurodegenerative disorders.
While a number of companies cited continued supply chain issues in recent investor calls and earnings reports, few med-tech leaders have expressed concerns about serious disruption to operations or loss of revenue because of the destruction wrought by the invasion of Ukraine or the associated sanctions on Russia. Most companies derive less than 1% of their revenue from the two countries.
With the World Health Organization’s COVAX facility having more COVID-19 vaccine doses available than have been requested by the countries it was designed to help, industry groups are pushing back against the proposed TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver for COVID-19 vaccines that has been agreed to by the EU, India, South Africa and the U.S.
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