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Home » Authors » Tamra Sami

Tamra Sami

Articles

ARTICLES

Australia considers naming requirements for biosimilars, input from overseas regulators

Aug. 7, 2017
By Tamra Sami
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is asking for industry feedback on whether Australia should change its naming mechanisms for biosimilars and biologics and if it should adopt practices of other international regulators.
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Australia moves toward aligning device regulations with the European Union

Aug. 2, 2017
By Tamra Sami

Australian patients get help via amended access plan for unapproved drugs, devices

Aug. 2, 2017
By Tamra Sami
PERTH, Australia – Patients in Australia will now be able to get unapproved drugs through their doctors more quickly since Australia amended its drug and device regulations earlier this year.
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Australian patients get help via amended access plan for unapproved drugs, devices

Aug. 1, 2017
By Tamra Sami

Australian patients get help via amended access plan for unapproved drugs, devices

July 31, 2017
By Tamra Sami
PERTH, Australia – Patients in Australia will now be able to get unapproved drugs through their doctors more quickly since Australia amended its drug and device regulations earlier this year.
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Speedx aims to market first molecular test for antibiotic-resistant emerging STD

July 28, 2017
By Tamra Sami

Dimerix's lead compound meets primary endpoints in phase II CKD trial

July 19, 2017
By Tamra Sami
PERTH, Australia – Dimerix Ltd. reported positive phase IIa data with its lead program, DMX-200, in chronic kidney disease. The dose-escalation trial met the primary endpoints of safety and tolerability, and it met secondary efficacy endpoints with 25 percent of patients achieving a greater than 50 percent reduction in proteinuria, which is over and above the standard of care, CEO Kathy Harrison told investors during a conference call last Thursday.
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Australia device trials grow with increase in government-backed infrastructure

July 17, 2017
By Tamra Sami

Dimerix's lead compound meets primary endpoints in phase II CKD trial

July 14, 2017
By Tamra Sami
PERTH, Australia – Dimerix Ltd. reported positive phase IIa data with its lead program, DMX-200, in chronic kidney disease.
Read More

Proposal to use Australian conformity assessment bodies gets mixed response

July 13, 2017
By Tamra Sami
View All Articles by Tamra Sami

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