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Home » Authors » Tamra Sami

Tamra Sami

Articles

ARTICLES

Avita raises AU$120M to expand international footprint, fund new pipeline indications

Nov. 14, 2019
By Tamra Sami
PERTH, Australia – Melbourne-headquartered regenerative medicine company Avita Medical Ltd. raised AU$120 million (US$81 million) in an institutional placement that will fund pipeline development of new indications for its Recell spray-on-skin treatment and expand its commercial footprint in the U.S. and Japan.
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Australian-EU-flags

TGA asked to hold off on device reclassification pending implementation of EU's MDR

Nov. 13, 2019
By Tamra Sami
Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.
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Australian flag marking country on globe
AusBiotech 201

National stem cell roadmap provides cohesive vision, funding for Australia's regenerative medicine sector

Nov. 12, 2019
By Tamra Sami
MELBOURNE, Australia – Although Australia was one of the first movers in the regenerative medicine space, until now a cohesive plan for investing in regenerative medicine was holding the sector back.
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Australia's Cartherics creates next generation CAR T therapies

Nov. 10, 2019
By Tamra Sami
PERTH, Australia – Melbourne-based Cartherics Pty Ltd. plans on taking its pluripotent stem cell technology into the clinic next year. It is employing advanced gene editing techniques for the next generation of CAR T therapy.
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Globe showing Australia

Australia moves to reclassify implantable spinal devices to mirror EU device regulations

Nov. 8, 2019
By Tamra Sami
PERTH, Australia – Although medical device industry stakeholders agreed in principle with the Australian Therapeutic Goods Administration's (TGA) proposal to align its classification with the EU's for implantable spinal devices, they viewed the interpretation of the EU Medical Device Regulation (MDR) classification rule for these devices differently.
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Globe showing Australia
AusBiotech 2019

Australia's biotechs grapple with reimbursement system for cell therapies

Nov. 6, 2019
By Tamra Sami
Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies.
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AusBiotech 2019

Aussie immunology startup Kira Biotech launches with AU$20M series A financing

Nov. 6, 2019
By Tamra Sami
Brisbane-based Kira Biotech Pty Ltd. is poised to enter the clinic after raising AU$20 million (US$13.72 million) in series A funding to develop therapies targeting immune system disorders. The round was led by Oneventures, one of Australia's leading venture capital firms with more than AU$330 million in funds under management.
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Genetic-Signature-product-line

Genetic Signatures ready to go global with AU$35M raise

Nov. 6, 2019
By Tamra Sami
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. is poised to extend its global footprint to the U.S. and Europe following its AU$35 million (US$24 million) capital raise.
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AusBiotech 2019

Australia's biotechs grapple with reimbursement system for cell therapies

Nov. 4, 2019
By Tamra Sami
MELBOURNE, Australia – Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies so that patients can access them.
Read More
AusBiotech 2019

Aussie immunology startup Kira Biotech launches with AU$20M series A financing

Oct. 31, 2019
By Tamra Sami
MELBOURNE, Australia – Brisbane-based Kira Biotech Pty Ltd. is poised to enter the clinic after raising AU$20 million (US$13.72 million) in series A funding to develop therapies targeting immune system disorders.
Read More
View All Articles by Tamra Sami

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