Shanghai Heartcare Medical Technology Co. Ltd. shares took a hard fall in their Aug. 20 debut on the Hong Kong Stock Exchange (HKSE), closing at HK$129 (US$107.47) after tumbling all the way down to HK$127.8 earlier in the day.
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18.
PERTH, Australia – Tali Digital Ltd. inked a licensing deal worth A$51 million (US$37.5 million) for its new digital therapeutic that could be the first line in early intervention to treat the underlying conditions of attention deficit disorders. Akili Interactive Labs Inc. will hold an ongoing license to Tali’s technology to become the exclusive commercialization partner for all pediatric cognition products in the U.S.
Fujifilm Holdings Corp. has bagged the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)’s approval for CXR-AID, its artificial intelligence (AI) powered chest X-ray analysis system developed in collaboration with Lunit Inc.
Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote.
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of devices currently on the market, and these devices will need to be re-registered if they are to stay on the market.
Innocare Pharma Ltd. has signed a licensing agreement with Incyte Corp. for the exclusive rights to the monoclonal antibody Monjuvi (tafasitamab) for hematology and oncology indications in mainland China, Hong Kong, Macau and Taiwan. Under the terms of the deal, Innocare will pay Incyte an up-front fee of $35 million, as well as up to $82.5 million in potential development, regulatory and commercial milestones and tiered royalties.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has cleared Speedx Pty Ltd.’s PlexPCR SARS-CoV-2 test, which detects all current circulating variants of the SARS-CoV-2 virus at a time when most of the country is in lockdown as the delta variant circulates.
While the increased use of virtual appointments has made care more accessible for many people during the pandemic, it has created challenges for providers who often lack a means to gather basic health data from patients. Advanced Human Imaging Ltd. (AHI), formerly Myfiziq Ltd., tackled the problem with a scanning technology that eliminates the need for basic vital sign equipment during telehealth visits by calculating blood pressure, heart and respiratory rate, and body mass index with a quick scan performed on a smartphone or webcam.
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