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.
PERTH, Australia – Bioinformatic and cell technology company Genieus Genomics Ltd. is using the power of the human genome to build a platform for neurodegenerative diseases to develop diagnostic tests for personalized medicines.
The Make in India initiative will be a long-term driver of local medical device manufacturing and will boost exports as well as a production linked incentive scheme, according to a report by market research firm Fitch Solutions.
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.
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.
Pulse Medical Imaging Technology (Shanghai) Co. Ltd. has raised more than $100 million in a series C funding round to accelerate the R&D, clinical trials and commercialization of its products. “Pulse plans to use the funds to accelerate the commercialization of its fractional flow reserve (FFR) estimating systems,” Xiaojie Lin, marketing director of Pulse, told BioWorld. FFR is a method to measure blood pressure and flow within a coronary artery to check on the possibility that the stenosis impedes oxygen delivery to the heart muscle.
Hong Kong Exchanges and Clearing Ltd. (HKEX) has taken the first step towards allowing listings on the market via special purpose acquisition companies (SPACs), also known as “blank check” companies. The move has left biotech companies wondering if the change could provide the next big opportunity to join the market after pre-revenue companies were first allowed to list there under a 2018 main board listing rule paved the path for them to do so.
Preliminary real-world data showed that Chinese inactivated vaccines are 63% protective against the COVID-19 Delta variant, China’s top epidemiologist Zhong Nanshan said at the 24th Respiratory Disease Academic Conference of Guangdong Medical Association in Guangzhou.
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