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Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020.
After listing on the Nasdaq market on May 18, Hong Kong-based diagnostics and genetic testing company Prenetics Group Ltd. saw its shares fall nearly 30% in early trading, dropping from $8.40 per share on listing to $5.70 by the end of trading May 19. Trading under the ticker PRE, Prenetics formed a merger with Artisan Acquisition Corp., a special purpose acquisition company, which was founded by entrepreneur Adrian Cheng. The transaction values Prenetics at an enterprise value of $1.25 billion, making the company the first Hong Kong unicorn to list on the Nasdaq.
Turning Point Therapeutics Inc. has picked up near-global rights to develop and commercialize an antibody drug conjugate (ADC) targeting Claudin18.2 from Lanova Medicines Ltd. for $25 million up front. The deal excludes greater China and South Korea.
In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
Visus Therapeutics Inc. has out-licensed phase III candidates Brimochol and Carbachol to Hong Kong’s Zhaoke Ophthalmology Ltd. to develop and commercialize its long-acting, presbyopia-correcting eye drops in greater China, South Korea and select Southeast Asian territories.
Microbiome-modulating therapies are increasingly being explored to treat a variety of diseases. However, the market is still in its infancy and a lack of solid regulations remains challenging for companies to overcome, speakers at the BioKorea 2022 said May 11.
As the COVID-19 pandemic slowly starts to ease globally, efforts are already gearing up to predict the next potential pandemic. One institute researching the increasing number of diseases transmitted from animals to humans is Canada’s Vaccine and Infectious Disease Organization, part of the University of Saskatchewan.
Visus Therapeutics Inc. has out-licensed phase III candidates Brimochol and Carbachol to Hong Kong’s Zhaoke Ophthalmology Ltd. to develop and commercialize its long-acting, presbyopia-correcting eye drops in greater China, South Korea and select Southeast Asian territories.
Shanghai Heartcare Medical Technology Corp. Ltd. received marketing approvals for three medical devices designed for stroke, namely its left atrial appendage (LAA) occluder, the aspiration catheter, and the support catheter.
As the COVID-19 pandemic slowly starts to ease globally, efforts are already gearing up to predict the next potential pandemic. One institute researching the increasing number of diseases transmitted from animals to humans is Canada’s Vaccine and Infectious Disease Organization, part of the University of Saskatchewan. Now, together with collaborators including the Canadian government, it’s sponsoring a phase II trial of COVAC-2, a squalene-in-water adjuvanted microsphere peptide-based protein subunit vaccine that contains a portion of the SARS-CoV-2 spike protein.
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