PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).
HONG KONG and BEIJING – Hong Kong-listed China Grand Pharmaceutical and Healthcare Holdings Ltd. and Niel, Belgium-based mRNA vaccine specialist Etherna Immunotherapies NV are setting up a joint venture to develop, produce and commercialize mRNA prophylactic and therapeutic vaccines.
An international study led by Nanyang Technological University in Singapore has designed and synthesized broad-spectrum antimicrobial polymers (AMPs) and demonstrated the safety and efficacy of two such agents against multidrug-resistant (MDR) bacteria in mouse models of sepsis.
Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
HONG KONG – Singapore-based X-Zell Biotech Pte. Ltd. has emerged as the winner of the Medtech Innovator Asia Pacific 2020 Accelerator program, as determined by a live virtual audience vote. Winning the competition, organized by Medtech Innovator and the Asia Pacific Medical Technology Association (APACMed), earned X-Zell a $150,000 non-dilutive grand prize to advance its business goals and mission.
PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group.
HONG KONG – Galmed Pharmaceuticals Ltd. has signed a research and development collaboration agreement with fellow Israeli biotech company Mybiotics Pharma Ltd. to identify and optimize the selected microbiome repertoire associated with the response to Aramchol (arachidyl amido cholanoic acid), Galmed’s fatty acid bile acid conjugate treating nonalcoholic steatohepatitis.
LONDON – A second COVID-19 vaccine has reported positive results in an interim phase III analysis, with Russia’s Sputnik V showing 92% efficacy. The news comes two days after the first readout from a phase III COVID-19 vaccine trial reported 90% efficacy for Pfizer Inc. and Biontech SE’s BNT-162b2.
HONG KONG – Kira Pharmaceuticals is riding high after completing a $46 million fundraiser and appointing Frederick Beddingfield as CEO. “The $46 million comprises a series A of $18 million and a series B of $26 million, with investors Quan Capital, 6 Dimensions Capital, Qiming Venture Partners, and Sinopharm Capital participating in both rounds,” Beddingfield told BioWorld.
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