LONDON – Astrazeneca plc is to get up to $1.2 billion from the new U.S. COVID-19 vaccines program, Operation Warp Speed, to support further development and manufacturing of a vaccine developed at Oxford University’s Jenner Institute. The company said it will begin to ship the product in September 2020, with the U.K. and U.S. first in line for deliveries.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.
PARIS – Intrasense SA, of Montpellier, France, has gained CE marking for its CT scanner reading protocol designed for COVID-19. “This major step forward, coming at the same time as U.S. FDA clearance, will allow a true mass rollout of our Myrian XP-Lung system designed for COVID-19,” Nicolas Reymond, CEO of Intrasense, told BioWorld.
LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test. The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June.
LONDON – Geopolitical tensions over the issue of access to COVID-19 vaccines intensified this week, after the CEO of French pharmaceutical company Sanofi SA said the U.S. government would get first access to its product because it was first to fund the research.
LONDON – The U.K. is launching a £28 million (US$34.5 million) project to sequence the whole genome of every COVID-19 patient in the country treated in intensive care, with the aim of uncovering host genetic factors that lead some people to be more severely affected by the infection. The study will involve up to 20,000 people currently or previously treated in one of 170 intensive care units (ICUs), whose genomes will be compared to 15,000 people with a confirmed infection who had mild or moderate symptoms.
DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million.
LONDON – A new technique for analyzing solid tumor DNA has been shown to significantly improve scoring of mutation burden, making it possible to identify patients who will respond to immunotherapy.
The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.