PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars.
Medtronic plc has launched Careguidepro, its first patient-focused digital tool for spinal cord stimulation. The mobile app and online portal enables providers to better manage patients’ pain relief with real-time feedback and data.
PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience. The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities.
In just one quarter, 14 med-tech companies overall, nearly half the number in 2020, debuted on public markets around the world, and venture capital (VC) financings for the industry have hit a five-year record. The IPOs raised a total of $3.7 billion, a more than 15-fold increase from last year’s first quarter, whereas 107 VC rounds brought in 77% more, or $4.1 billion, in the first quarter (Q1) of 2021.
CAJICA, Colombia – The tiny Central American country of Costa Rica continues to cement its position as Latin America’s med-tech powerhouse after experiencing double-digit growth in exports in the first two months of the year, according to data released by Procomer, the country's exports promotion agency. “These numbers become more relevant when detailing that medical devices and precision equipment represent, for the third consecutive year, the country's main export, which had double-digit growth of 23%, thus representing 36% of the exports of the country,” the Costa Rican government said.
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.
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