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Home » Authors » Tamra Sami

Tamra Sami

Articles

ARTICLES

Australia: No plans to regulate AI, machine learning via separate pathway

Aug. 23, 2019
By Tamra Sami
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.
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Australia: No plans to regulate AI, machine learning via separate pathway

Aug. 23, 2019
By Tamra Sami
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.
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Okogen begins phase II trial in Australia with topical ranpirnase to fight adenoviral conjunctivitis

Aug. 14, 2019
By Tamra Sami
PERTH, Australia – San Diego-based Okogen Inc. is taking its clinical trial program to Australia where it will test its lead compound OKG-0301 for acute adenoviral conjunctivitis in the phase II (RUBY) trial.
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Polyactiva raises AU$10M on heels of phase I trial of glaucoma implant

Aug. 12, 2019
By Tamra Sami

Okogen begins phase II trial in Australia with topical ranpirnase to fight adenoviral conjunctivitis

Aug. 12, 2019
By Tamra Sami
PERTH, Australia – San Diego-based Okogen Inc. is taking its clinical trial program to Australia where it will test its lead compound OKG-0301 for acute adenoviral conjunctivitis in the phase II (RUBY) trial.
Read More

TGA says alternatives to CE marking available via other authorities

Aug. 9, 2019
By Tamra Sami

Opthea's stock gains 138% on positive phase IIb results in wet AMD trial

Aug. 7, 2019
By Tamra Sami

PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive phase IIb results demonstrating that OPT-302 combination therapy met the primary endpoint of superiority in mean visual acuity gain at 24 weeks compared to Lucentis (ranibizumab, Roche Holding AG/Novartis AG) monotherapy in treatment-naïve patients with wet age-related macular degeneration (AMD).


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Aussie radiopharma Telix raises AU$40M as it advances to late-stage trials

Aug. 1, 2019
By Tamra Sami

Aussie Noxopharm announces AU$26M funding facility ahead of planned U.S. Nasdaq listing

July 31, 2019
By Tamra Sami
PERTH, Australia – Following positive results across three different oncology clinical trial programs with its lead candidate, Veyonda, Sydney-based Noxopharm Pty Ltd. has secured a AU$26 million (US$18 million) funding facility from U.S. investors leading up to a proposed Nasdaq listing.
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Aussie radiopharma Telix raises AU$40M as it advances to late-stage trials

July 31, 2019
By Tamra Sami
PERTH, Australia – Telix Pharmaceuticals Ltd. raised AU$40 million as it prepares regulatory packages and commercial strategies in Europe, the U.S. and Australia.
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View All Articles by Tamra Sami

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