Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.
China’s ongoing efforts to tighten regulations across the board is hitting medical device companies. Two companies that issued shares in Hong Kong for the first time over the past week saw their shares tumble right out of the gate. Acotec Scientific Holdings Ltd. (HK: 6669) shares fell more than 25% on their first trading day on the Hong Kong Stock Exchange on Aug. 24 amid regulatory changes in China’s health care industry.
The use of voice recognition systems based on artificial intelligence (AI) in health care is emerging in India, which offers a potentially enormous market, according to Scribetech Healthcare (India) Pvt. Ltd., one of the leading voice recognition companies in the country.
PERTH, Australia – Cardiovascular medical device company Venstramedical Ltd. has raised $2 million in seed funding to support development of a small catheter-inserted collapsible heart pump. The Sydney-based company is aiming to develop devices that provide cardiac support for failing hearts without the use of surgery, Venstramedical co-founder and CEO Martin Cook told BioWorld.
Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.
Vigencell Inc., a company focused on immune cell therapy, raised ₩99.4 (US$85.17 million) through an IPO on South Korea’s Kosdaq board and plans to use the funds to drive its R&D and company operations. “We particularly want to increase the competitiveness of our pipeline by advancing our technology and clinical development,” Vigencell CEO Tai-Gyu Kim told BioWorld. “We will also expand our discovery of new candidates and R&D in general, as well as updating our facilities and hiring researchers.”
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.
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.