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Home » Authors » Tamra Sami

Articles by Tamra Sami

Invitrocue is building personal tumor avatars to transform personalized medicine

Aug. 25, 2017
By Tamra Sami
PERTH, Australia – A new technology spun out of Singapore's Agency for Science, Technology and Research (A*STAR) could change cancer treatment by building cell-based tumor avatars in the lab to test them against a multitude of drugs.
Read More

Sienna Cancer Diagnostics eyes U.S. for bladder cancer IVD following Australian IPO

Aug. 18, 2017
By Tamra Sami

Starpharma readies U.S. NDA for Vivagel on positive phase III results in bacterial vaginosis

Aug. 9, 2017
By Tamra Sami
PERTH, Australia – Melbourne-based biotech Starpharma Ltd. expects to file its rolling NDA with the FDA in the next month following positive phase III results for Vivagel BV for preventing recurrent bacterial vaginosis.
Read More

Australia considers naming requirements for biosimilars, input from overseas regulators

Aug. 9, 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.
Read More

Starpharma readies U.S. NDA for Vivagel on positive phase III results in bacterial vaginosis

Aug. 9, 2017
By Tamra Sami
PERTH, Australia – Melbourne-based biotech Starpharma Ltd. expects to file its rolling NDA with the FDA in the next month following positive phase III results for Vivagel BV for preventing recurrent bacterial vaginosis.
Read More

FDA clears cognition assessment system that may help trial sites with patient selection

Aug. 8, 2017
By Tamra Sami

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.
Read More

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.
Read More

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

Aug. 1, 2017
By Tamra Sami
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