Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers.
SHANGHAI – China’s regulatory environment has evolved to encourage drug innovation, but despite remarkable progress, mounting pricing pressure from the government and a weak insurance sector remain as barriers.
With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.”
HONG KONG – Coreline Soft Co. Ltd. has taken its first step into the Greater China market after receiving approval from Taiwan’s Food and Drug Administration (TFDA) on April 8 for its Aview suite of artificial intelligence (AI) medical solutions.
PERTH, Australia – Australia’s TGA issued final guidance on clinical evidence requirements for medical devices in response to updated regulations that have resulted in changes to evidence requirements. Clinical evidence is required for all medical devices and in vitro diagnostics (IVDs) that are listed on the Australian Register of Therapeutic Goods (ARTG). The clinical evidence requirements apply when a device is first listed as well as over the lifecycle of the device. If safety issues are identified, the TGA may ask manufacturers to update clinical information to more accurately reflect risk.
PERTH, Australia – Analytica Ltd. signed a joint venture agreement with Hebei Nacol Bio-Technology Co. Ltd. and Shijiazhuang Biosphere Pty Ltd., of Hebei Province, China, to manufacture and distribute its Pericoach device for urinary incontinence in China, Macau, Hong Kong and Taiwan.
PERTH, Australia – In a boost for Australia’s medical technology innovators, A$3.2 million (US$2.4 million) in partnership projects are being deployed to help get innovative new medical devices to the next steps of starting human trials and early-stage manufacturing.
PERTH, Australia – Ferronova Ltd. has developed an injectable magnetic and fluorescent tracer that can map the spread of cancer in the lymph nodes more accurately for improving the staging of complex cancers. The polymer-coated iron oxide nanoparticles show more detailed assessment of sentinel lymph nodes and detect micro-metastasis and isolated tumor cells that would otherwise not be detected.
HONG KONG – Chugai Pharmaceutical Co. Ltd. has obtained Ministry of Health, Labor and Welfare (MHLW) approval for a combination regimen containing antimicrotubule binding anti-CD79b monoclonal antibody Polivy (polatuzumab vedotin), bendamustine and Mabthera (rituximab) to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Qihan Biotechology Co. Ltd., a company known for its multiplexable genome editing technology, has yet again extended its series A financing, this time with a $67 million round that will support advancement of its allogeneic cell therapy candidates to IND in China. To date the company has raised more than $100 million.
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