Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices.
The medical device incubator Coridea LLC and the health care investment firm Deerfield Management Co. LP are joining forces to accelerate the formation of med-tech companies on the East Coast.
A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products.
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization Director-General Ngozi Okonjo-Iweala said at the Global C19 Vaccine Supply Chain and Manufacturing Summit.
According to the latest annual overview published by trade association France Biotech, French med-tech, biotech, and e-health companies have adapted rapidly to the COVID-19 pandemic. Many French health care companies have faced real difficulties in all areas of procurement, R&D, and sales. As of February, a quarter of these French companies were redirecting their research activity towards the coronavirus.
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit.
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
LONDON – Oxular Ltd. has raised $37 million in a series B, enabling the company to take OXU-001, its long-acting treatment for diabetic macular edema (DME) into phase II development later this year.
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.