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Home » Authors » Tamra Sami

Articles by Tamra Sami

Industry taken off guard by TGA move to charge first-ever fees for class I devices

June 8, 2018
By Tamra Sami

Australia's TGA clarifies regulatory requirements for in-house IVD tests

June 7, 2018
By Tamra Sami

Immutep's LAG-3 immunotherapy shows promise for boosting efficacy of Keytruda

June 6, 2018
By Tamra Sami
PERTH, Australia – Sydney-based Immutep Ltd. unveiled new data for its phase I immunotherapy study that showed a long-lasting and durable response and an overall response rate of 61 percent in a melanoma study combining its lead immunotherapy with Merck's anti-PD-1 therapy Keytruda (pembrolizumab).
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Industry opinion mixed as TGA implements new fee structure for GMP inspections

May 30, 2018
By Tamra Sami
PERTH, Australia – In response to industry comments, Australia's Therapeutic Goods Administration (TGA) is getting ready to implement a new fee structure for drug GMP inspections.
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Australia's BTF invests in Bivacor's artificial heart

May 29, 2018
By Tamra Sami

Trial shows Minomic's prostate cancer diagnostic Micheck is twice as specific as standard PSA test

May 24, 2018
By Tamra Sami
PERTH, Australia – Sydney-based Minomic International Ltd.'s Micheck prostate cancer diagnostic was more than twice as specific in screening for prostate cancer than the standard of care prostate specific antigen (PSA) screening technology, a recent clinical trial showed. The Micheck diagnostic met both primary endpoints in a U.S. multicenter trial in 384 patients. The trial was a prospective, non-randomized case-control study, with a primary endpoint of detecting prostate cancer versus no cancer, and a secondary endpoint of differentiating between aggressive and non-aggressive cancer.
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Multinational firms see promise in building up ecosystem in Oz

May 21, 2018
By Tamra Sami

Australian budget reforms R&D tax credit but exempts trials from annual cap

May 16, 2018
By Tamra Sami
PERTH, Australia – Industry stakeholders praised Australia's federal budget for 2018-2019, released late last week, because the government said it was seeing results from investments pumped into the medical technology and pharmaceuticals sector, and it will continue to invest more.
Read More

Australian budget reforms R&D tax credit but exempts trials from annual cap

May 14, 2018
By Tamra Sami

Australian budget reforms R&D tax credit but exempts trials from annual cap

May 14, 2018
By Tamra Sami
PERTH, Australia – Industry stakeholders praised Australia's federal budget for 2018-2019, released late last week, because the government said it was seeing results from investments pumped into the medical technology and pharmaceuticals sector, and it will continue to invest more.
Read More
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