LONDON - The world’s first COVID-19 human challenge trial is due to start in London next year, after the government announced £33.6 million (US$42.5 million) funding for the project. In the initial phase, the aim is to establish the dose of SARS-CoV-2 needed to cause infection and to characterize the immune response to virus. That will lead on to tests of individual COVID-19 vaccines, in which volunteers will be challenged with the effective dose of SARS-CoV-2 one month after inoculation.
Tracking the pandemic in all its manifestations – from symptoms and spread, to viral genomics and repurposing drugs – has massively increased appreciation of the importance of real world data, with significant implications for the future of drug discovery and clinical development, the use of patient data and health care as a whole.
LONDON – Facing down the pandemic, U.K. biopharma had a record summer, raising just over £1 billion (US$1.3 billion) from June to August. That was up from £585 million in the second quarter of 2020, and brings the amount raised in the first nine months to £1.9 billion, putting 2020 on target to beat the 2018 record, when the annual total was £2.2 billion.
LONDON – Clinical care guidelines recommending the use of the HIV/AIDS combination lopinavir-ritonavir for the treatment of patients hospitalized with COVID-19 must now be updated, say the authors of a paper reporting the full results of a randomized U.K. study showing the antiviral is not effective in this context, published in The Lancet on Oct. 5.
DUBLIN – In what continues to be a year like no other, European biotechnology firms engaged in drug development raised $4.783 billion in equity financing during the third quarter. It is an unprecedented level of funding for the sector.
DUBLIN – The ongoing legal uncertainty surrounding the transfer of data from European research institutions or companies to international partners shows little sign of resolution, despite the urgency of the COVID-19 pandemic, which has engendered an extraordinary collaborative response from the global scientific community.
LONDON – As the last scheduled talks on the future EU/U.K. trading arrangements got underway on Sept. 29, the pharmaceutical industry across Europe issued an urgent plea for medicines to be spliced out of the contentious negotiations. In a joint statement, the U.K. and European industry organizations called for a mutual recognition agreement (MRA) to prevent the need for retesting of medicines imported from the EU to the U.K., in the event there is no deal.
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities.
LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.