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BioWorld - Monday, May 16, 2022
Home » Topics » Asia-Pacific » Australia

Australia
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Atmo CEO holding capsule

Atmo raises AU$9.6M to progress ingestible capsule for analyzing the gut microbiome

Sep. 24, 2021
By Tamra Sami
No Comments
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.
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Australian flag on laptop screen with health professional

TGA provides clarity on software for rapid antigen tests for COVID-19

Sep. 21, 2021
By Mark McCarty
No Comments
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).
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australia-flag-country.png

Device regulation changes in Australia result in conformity assessment changes

Sep. 21, 2021
By Tamra Sami
No Comments
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).
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Paul Hopper, founder and executive chairman, Radiopharm Theranostics
Newco news

Entrepreneur Paul Hopper launches Radiopharm Theranostics following AU$20M series A

Sep. 17, 2021
By Tamra Sami
No Comments
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.
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Jennifer MacDiarmid and Himanshu Brahmbhatt, co-founders and co-CEOs, Engeneic Ltd.

Australia’s Engeneic enters clinic with nanocellular COVID-19 vaccine

Sep. 14, 2021
By Tamra Sami
No Comments
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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TGA: Immunobridging OK for variant-based COVID-19 vaccines

Sep. 14, 2021
By Mari Serebrov
No Comments
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.
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Jennifer MacDiarmid and Himanshu Brahmbhatt, co-founders and co-CEOs, Engeneic Ltd.

Australia’s Engeneic enters clinic with nanocellular COVID-19 vaccine

Sep. 8, 2021
By Tamra Sami
No Comments
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.
Read More
IPO puzzle pieces

Following A$90M IPO, Trajan doubles share price as it executes global strategy

Sep. 3, 2021
By Tamra Sami
No Comments
PERTH, Australia – On the heels of a A$90 million (US$67.12 million) initial public offering on the Australian Securities Exchange, device company Trajan Group Holdings Ltd. has doubled its share price and is well poised for its next stage of global growth. Trajan makes precision consumable products, devices and solutions that used in analyzing biological samples.
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Flag of Australia, sky background

TGA sues Medtronic for alleged unlawful supply of Infuse bone graft kit

Sep. 1, 2021
By Tamra Sami
No Comments
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd. for alleged unlawful supply of its Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients.
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3D heart in chest

Venstramedical raises $2M in seed funding to progress next-gen miniature heart pump

Aug. 26, 2021
By Tamra Sami
No Comments
PERTH, Australia – Cardiovascular medical device company Venstramedical Ltd. has raised $2 million in seed funding to support development of a small catheter-inserted collapsible heart pump. The Sydney-based company is aiming to develop devices that provide cardiac support for failing hearts without the use of surgery, Venstramedical co-founder and CEO Martin Cook told BioWorld.
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