The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
PARIS – Corwave SA has obtained $600,000 as part of the Ile-de-France region's stimulus plan, to boost development of its Neptune cardiac support pump. This subsidy is part of the manufacturing recovery plan for the Ile-de-France region, aimed at very small enterprises (VSEs), small and medium-sized enterprises (SMEs) and mid-cap companies. In the midst of the COVID-19 pandemic, the Ile-de-France Region is supporting re-industrialization in a region that brings together 12.1 million inhabitants, or nearly 19% of the French population.
Salient Bio launched a robotics-driven PCR test for COVID-19 with 99% for use in mass testing for the virus. The company says the "fastest ever" test notifies users of test results in less than a day and is priced to be cost effective for businesses. Salient plans to expand the number of tests utilizing the modular diagnostics platform in 2021 to include a range of pathogens. Even with vaccines on the horizon in the coming months, the London-based company expects brisk demand for its product.
Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
LONDON – The 10 weeks of laboratory time lost during the first U.K. COVID-19 lockdown will translate to a 17-month delay in oncology drug discovery and development projects, according to the Institute of Cancer Research (ICR) in London.
Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.