Asia-Pacific

SK invests in Standigm for AI-based drug development

November 20, 2019

HONG KONG – SK Holdings Co. Ltd. invested ₩10 billion (US$8.6 million) in Standigm Inc., an artificial intelligence (AI)-powered biotech company based in Seoul, Korea. It is the second big investment Standigm has attracted this year after a ₩13 billion series B round in March.

TGA shies away from up-classifying all accessories for implantable devices

November 18, 2019

By Tamra Sami

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Australia's Therapeutic Goods Administration (TGA) proposed classifying active implantable medical devices (AIMDs), their accessories and active devices for controlling, monitoring or influencing the performance of an active device and software as high-risk class III devices. However, the agency has rethought the notion of up-classifying all implant device accessories after blowback from industry.

Aussie device makers urge TGA to follow IMDRF lead on software regulations

November 13, 2019

By Mark McCarty

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Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.

TGA asked to hold off on device reclassification pending implementation of EU's MDR

November 13, 2019

By Tamra Sami

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Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.

Chinatrials12 Summit

With the help of trial experts, Chinese biotechs set sail for global market

November 13, 2019

By Elise Mak

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SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.

Australia moves to reclassify implantable spinal devices to mirror EU device regulations

November 8, 2019

By Tamra Sami

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PERTH, Australia – Although medical device industry stakeholders agreed in principle with the Australian Therapeutic Goods Administration's (TGA) proposal to align its classification with the EU's for implantable spinal devices, they viewed the interpretation of the EU Medical Device Regulation (MDR) classification rule for these devices differently.

Genetic Signatures ready to go global with AU$35M raise

November 6, 2019

By Tamra Sami

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PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. is poised to extend its global footprint to the U.S. and Europe following its AU$35 million (US$24 million) capital raise.

Sulfide stress as new target?

Schizophrenia biomarker can be detected in human hair

November 5, 2019

By John Fox

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A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan.

Azoth and Wellmarker Bio to collaborate in AI-based cancer drug development

November 4, 2019

By Jihyun Kim

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HONG KONG – South Korean AI-based biotech Azoth Bio Inc., of Seongnam, Gyeonggi-do, and biopharmaceutical venture Wellmarker Bio Co. Ltd., based in Seoul, have signed a memorandum of understanding for cancer drug R&D and commercialization. Under the agreement, the two entities will use Azoth's AI-powered platform to develop Wellmarker's cancer treatment candidates.

Small molecules clear mutant Huntingtin protein

November 1, 2019

By John Fox

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A Chinese study has identified small-molecule compounds that can selectively reduce levels of the mutant Huntingtin (HTT) protein involved in the pathogenesis of Huntington's disease (HD), and possibly other neurodegenerative diseases involving mutant protein accumulation.