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Home » Authors » Tamra Sami

Tamra Sami

Articles

ARTICLES

Biobridge programs link Australian med techs to U.S., China

June 22, 2018
By Tamra Sami

Aussie nonprofit gains FDA approval, along with PRV for river blindness drug

June 20, 2018
By Tamra Sami
PERTH, Australia – Melbourne-based Medicines Development for Global Health (MDGH) became the first not for profit company to register a drug through the FDA's tropical disease priority review program.
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Aussie nonprofit gains FDA approval, along with PRV for river blindness drug

June 19, 2018
By Tamra Sami
PERTH, Australia – Melbourne-based Medicines Development for Global Health (MDGH) became the first not for profit company to register a drug through the FDA's tropical disease priority review program.
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Sirtex terminates Varian deal, enters binding agreement with China's CDH for A$1.9B

June 18, 2018
By Tamra Sami

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

June 13, 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 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).
Read More

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
View All Articles by Tamra Sami

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