DUBLIN – The Biden administration’s proposals on global corporation tax reform have set alarm bells ringing across the Irish government, as officials digest the possible implications of the plan for Ireland's foreign direct investment model of economic development.
DUBLIN – A newly published retrospective analysis of the electronic health care records of more than 500,000 COVID-19 patients has found that infection with SARS-CoV-2 carries “a significantly and substantially” greater risk of cerebral venous thrombosis (CVT) than does either one of the two approved mRNA COVID-19 vaccines or infection with influenza virus.
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial.
LONDON – The EMA has concluded that the rare cases of serious blood clots with low platelet counts seen after administration of Astrazeneca plc’s COVID-19 vaccine are caused by the vaccine, but said the benefits of its use continue to outweigh the risks. The possibility of cerebral venous sinus thrombosis and splanchnic vein thrombosis in the abdomen will now be listed as rare side effects and the EMA’s guidance to health care professionals will be updated.
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.
DUBLIN – European biotechnology firms engaged in drug discovery and development raised a record $5.9 billion in equity investment during the first quarter. It’s further evidence that the pace of biotech investing has become even more frenetic than last year’s full tilt. The first three months of the year can often be a quiet one for European biotech, but the amount raised in Q1 2021 comfortably exceeds the totals raised for all of 2016 and 2015. Venture capital investing, IPOs and share offerings by listed firms all performed strongly, dwarfing the equivalent figures for recent years. The new year has started with a big bang.
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
LONDON – A new route to the approval of drugs promises to smooth the path from clinical trials to approval, reimbursement and commissioning in the National Health Service, through closer and earlier collaboration between the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment bodies.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said.
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