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Home » Authors » Tamra Sami

Articles by Tamra Sami

Chinese VCs invest in Indonesia’s Etana Biotechnologies

Oct. 14, 2022
By Tamra Sami
PT Etana Biotechnologies Indonesia secured a series B financing of undisclosed value, led by Chinese investors that include Jack Ma’s Yunfeng Capital and Highlight Capital. The funds will be used to strengthen the company's pipeline and to expand its local manufacturing capacity.
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Cancer cell targeted in crosshairs

Quark Biosciences spins out cancer liquid biopsy company Pharus Diagnostics

Oct. 13, 2022
By Tamra Sami
Pharus Diagnostics Inc. emerged from stealth mode to streamline precision medicine-based cancer screening with its new multi-cancer early detection liquid biopsy test. Spun out from Hsinchu, Taiwan-based Quark Biosciences Taiwan Inc. in July 2022, Pharus is developing solutions to detect cancer early via Oncosweep, its multi-cancer early detection (MCED) liquid biopsy test that evaluates microRNA (miRNA) within the body.
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Flag of Australia, sky background

TGA clarifies regulatory pathways for drug-device combination products

Oct. 12, 2022
By Tamra Sami
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Read More
Scientist, microscope and dropper

Biomarker analysis yields clinical benefit for Actinogen’s Xanamem in Alzheimer’s disease

Oct. 11, 2022
By Tamra Sami
A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial.
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CSL’s Seqirus snags $30M contract with BARDA to develop pandemic avian flu vaccines

Oct. 11, 2022
By Tamra Sami
CSL Ltd. subsidiary Seqirus inked a $30.1 million deal with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop and evaluate two influenza A subtype H2Nx (avian flu) vaccines in a phase I trial.
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Industry lauds progress seen in Australia’s National Medicines Policy consultation

Oct. 11, 2022
By Tamra Sami
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
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CSL’s Seqirus snags $30M contract with BARDA to develop pandemic avian flu vaccines

Oct. 10, 2022
By Tamra Sami
CSL Ltd. subsidiary Seqirus inked a $30.1 million deal with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop and evaluate two influenza A subtype H2Nx (avian flu) vaccines in a phase I trial.
Read More

Industry lauds progress seen in Australia’s National Medicines Policy consultation

Oct. 7, 2022
By Tamra Sami
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
Read More
Atmo - CEO - Malcolm Hebblewhite

Atmo’s ingestible gas-sensing capsule tracks transit time through the gastrointestinal tract

Oct. 6, 2022
By Tamra Sami
Atmo Biosciences Ltd. is gearing up for pivotal trials of its ingestible gas-sensing capsule after a clinical study supported the gas capsule’s ability to determine its location in the gastrointestinal tract.
Read More

Lumos’ 510(k) hopes for Febridx quashed with second FDA rejection

Oct. 5, 2022
By Tamra Sami
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Read More
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