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PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic.
PERTH, Australia – Australia’s Atomo Diagnostics Pty. Ltd. is preparing to raise AU$30 million (US$11.7 million) in an initial public offering on Australia’s Securities Exchange (ASX) that will enable it to ramp up manufacturing for rapid self-tests for COVID-19. The Sydney-based company is working with several multinational diagnostics companies to develop the new COVID-19 blood tests, which would be integrated with Atomo’s existing rapid test platform currently used for HIV screening.
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
PERTH, Australia – Mesoblast Ltd. plans to evaluate remestemcel-L in patients with acute respiratory distress syndrome caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.
PERTH, Australia – While the coronavirus captures the world’s attention, another global pandemic is quietly killing 100 million people under the age of 60.
PERTH, Australia – On the heels of scoring a CE mark for its Novosorb biodegradable temporizing matrix (BTM) in the EU, Melbourne-based Polynovo Ltd. crossed its first AU$2 million (US$1.3 million) month in December sales for its initial commercial product.
PERTH, Australia – While the coronavirus captures the world’s attention, another global pandemic is quietly killing 100 million people under the age of 60, and Australian investors are putting up AU$53 million (US$34.58 million) to back late-stage projects at the George Institute for Global Health.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.
PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden...
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19....
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax...
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
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