The U.K. is mulling over whether to recognize U.S. FDA approvals of medical devices as part of moves to accelerate the implementation of its post-Brexit regulatory system.
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.
The U.K. National Institute for Health and Care Excellence has expanded its endorsement for the Greenlight XPS system for benign prostatic hyperplasia to no longer exclude patients deemed at high risk for hemorrhage, a decision that may boost utilization and thus sales of the XPS.
The U.K. Bioindustry Association (BIA) is in an eleventh hour fight against changes to R&D tax breaks that it estimates will result in a £400 million to £800 million (US$480 million to $960 million) cut in payments to the sector. The changes will see cash credit claims reduced from 14.5% to 10%, cutting payments from 33 pence per £1 of spend to 18.6 pence per pound of spend from April 2023. Along with other tweaks, this is an effective 50% cut for biopharmas that do not pay any corporation tax because they are loss-making.
After getting its 510(k) application rejected by the U.S. FDA for its AI-enabled Salix coronary anatomy software (SCA), Australian medical technology company, Artrya Ltd. scored regulatory approvals in the UK and in the EU.
The U.K. National Institute for Health and Care Excellence (NICE) has opened a consultation on the use of five digital health products that can be used to help children and adolescents better manage anxiety or low mood.
The U.K. is launching a £230 million (US$260 million) project to build a database linking the health records and genetic information of 5 million people, which will be open for discovery research and as a source of clinical trial recruits for academics and companies.
The U.K. is launching a £230 million (US$260 million) project to build a database linking the health records and genetic information of 5 million people, which will be open for discovery research and as a source of clinical trial recruits for academics and companies.
The U.K. is launching a coordinated national program of research into the unprecedented outbreak of monkeypox that has spread across Europe and North America – regions where the disease is not endemic – over the past six months. Taking a lead from the SARS-CoV-2 playbook, there will be work to sequence the viral genome and to study how it is evolving, linking this to changes in the transmission and pathology of the virus.
The U.K. is launching a coordinated national program of research into the unprecedented outbreak of monkeypox that has spread across Europe and North America – regions where the disease is not endemic – over the past six months. Taking a lead from the SARS-CoV-2 playbook, there will be work to sequence the viral genome and to study how it is evolving, linking this to changes in the transmission and pathology of the virus.