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PERTH, Australia – Melbourne-based regenerative medicine company Cynata Therapeutics Ltd. is enjoying a bit of hot pursuit as Fujifilm Corp. exercised its license option to develop and commercialize Cynata's lead Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) at the same time that Cynata is an acquisition target by Dainippon Sumitomo.
Melbourne, Australia-based regenerative medicine company Avita Medical Ltd. has received good news from the FDA. The company, which also has a presence in Valencia, Calif., said the agency gave its thumbs up to an investigational device exemption application for a pivotal trial (NCT04091672) evaluating the safety and effectiveness of the Recell autologous cell harvesting device in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving, crush wounds, abrasions, lacerations and surgical wounds.
PERTH, Australia – Australian cell therapy developer Mesoblast Ltd. has partnered with Germany's Grünenthal Group to develop and commercialize Mesoblast's allogeneic cell therapy candidate, MPC-06-ID, in a deal that carves out Europe, Latin America and the Caribbean.
PERTH, Australia – Stem cell therapy has failed to deliver on its promises, according to Exopharm Ltd. founder and CEO Ian Dixon, who said he believes that exosomes, or the extracellular vesicles released by stem cells, could be a disrupter in the regenerative medicine space.
PERTH, Australia – Stem cell therapy has failed to deliver on its promises, according to Exopharm Ltd. founder and CEO Ian Dixon, who said he believes that exosomes, or the extracellular vesicles released by stem cells, could be a disrupter in the regenerative medicine space.
PERTH, Australia – There is pervasive use of artificial intelligence and machine learning (AI/ML) across the health care industry in Australia, and excitement is building on the opportunities it offers to technologies and ultimately to patients, Ausbiotech CEO Lorraine Chiroiu told BioWorld Asia.
PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Instead, the Therapeutic Goods Administration (TGA) will classify AI and ML under software as a medical device (SaMD) when it is intended for diagnosis, prevention, monitoring or treatment or alleviation of disease.
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...
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....
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply...
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data...
Randomized trials of the broad-spectrum antiviral favipiravir, marketed as an anti-influenza treatment by Fujifilm Holdings Corp., have shown "obvious efficacy"...
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