LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.

PARIS – Mauna Kea Technologies SA, of Paris, is welcoming a major shareholder on board. The company, which developed Cellvizio optical biopsy technology for tissue imaging directly at the cellular level, reported an increase in share capital for the benefit of Johnson & Johnson Innovation, JJDC Inc. The venture capital arm of J&J has invested $8.3 million by subscribing to 5,357,142 new shares at a unit price of $1.56.

DUBLIN – Last year was yet another banner year for European biotechnology firms engaged in drug development. The sector took in $7.739 billion in equity funding in 2019, just edging past the previous high of $7.715 billion it reached in 2018. The second half of the year was a marked improvement on the first half, but that was linked to the timing of a couple of large-scale transactions.

LONDON – Twenty years on from sequencing of the first draft of the human genome and the associated hype, 2019 was the year that the science of genomics truly began to make an impact in health care.

LONDON – Following 3.5 years of uncertainty, the U.K. will be leaving the EU at 11 pm Jan. 31, after the newly elected Conservative government finally got the withdrawal agreement bill voted through Parliament Dec. 20, by a majority of 124.

LONDON – Following 3.5 years of uncertainty, the U.K. will be leaving the EU at 11 pm on Jan. 31, after the newly elected Conservative government finally got the withdrawal agreement bill voted through parliament on Dec. 20, by a majority of 124.

For biopharma, 2019 can be described as a terrific year – with a few asterisks. The financial markets were flourishing, with venture capital dollars, in particular, flowing to the sector, while dealmaking reached historic proportions. Meanwhile, scientific breakthroughs led the way as cell and gene therapies gained ground, the first signs of success emerged with new technologies like CRISPR and the long-awaited promise of genomics found its way to the front lines of health care.

PARIS – Diabnext SAS, of Versailles, France, has launched Clipsulin 3XS, a sensor intended to monitor and manage diabetes that the company says is compatible with all insulin pens on the market. “This is the first sensor that automatically reports insulin doses injected by the pen, in both children and adults,” Laurent Nicolas, co-founder and CEO of Diabnext, told BioWorld MedTech.

HONG KONG – Pentax Medical Co., of Tokyo, has gained CE marking for its artificial intelligence-based polyp detector Discovery. The detector assists endoscopists in finding potential polyps during a colorectal examination. The software has been trained using more than 120,000 files from about 300 clinical cases.

LONDON – While large-scale biobanks that link genomics to longitudinal health records of diagnosis, treatment and outcomes promise to revolutionize the understanding of the genetics of complex disease, the detailed statistical analysis of those high-dimensional data is still very much in its infancy.