PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product.
Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).
PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.
PERTH, Australia – Atmo Biosciences Ltd. has closed an oversubscribed AU$9.6 million (US$7 million) capital raise that will allow it to further develop its gas-sensing capsule for monitoring the health of the gut and the microbiome. Until now, there has not been a diagnostic test that can measure gases in the gut in vivo.
The COVID-19 pandemic is still swirling about, and rapid antigen tests are still playing a vital role in pushing back against the COVID-19 pandemic, and Australia’s TGA has responded with a guidance on when software used with rapid antigen tests qualifies as a regulated device. The TGA has classified such software as a class 3 device when used with a rapid antigen self-test, thus requiring a separate regulatory application before it can be eligible for entry in the Australian Register of Therapeutic Goods (ARTG).
PERTH, Australia – Changes to Australia’s medical device requirements have resulted in certain devices no longer requiring TGA conformity assessment certification, including class IV in vitro diagnostics (IVDs). As of July 23, 2021, devices that contain drugs or materials of animal, microbial, recombinant or human origin no longer require mandatory TGA conformity assessment certification. Instead, sponsors of these devices will be able to provide conformity assessment documents issued by notified bodies designated by a European Union member state to support their applications on the Australian Register of Therapeutic Goods (ARTG).
PERTH, Australia – After raising AU$20 million (US$14.62 million) in a series A round, serial entrepreneur Paul Hopper is unveiling his newest venture, Radiopharm Theranostics Ltd., which is developing a platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses.
PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.
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