PARIS – The Cour des comptes, supreme body for auditing the use of public funds in France, independent from government and parliament, has just released its report on the operation of the French National Agency for the Safety of Medicines and Health Products (ANSM). Following 10 months of administrative and financial investigation, these financial controllers have highlighted the weakness of controls applied to medical devices placed on the market in France.

Dublin-based Medtronic plc received a CE mark for its Percept PC neurostimulator to treat neurologic disorders such as Parkinson’s disease. It is the first deep brain stimulation system launched in the EU that integrates the company’s technology to sense and record brain signals, known as Brainsense. It’s intended to enable more personalized treatment driven by that data.

Issy-les-Moulineaux, France-based Withings SA said it’s planning to launch its latest product in the U.S. and Europe during the second quarter, the Scanwatch. It is expected to be the first smartwatch to offer both atrial fibrillation (AF) and sleep apnea detection; a CE mark and FDA clearance are both pending. Cardiac arrhythmia and sleep apnea are associated with one another and can be precursors to more serious health problems such as heart attack or stroke.

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.