Abogen Biosciences Co. Ltd. has raised $300 million in a series C+ round to support the development of its mRNA products, specifically to support the development of its COVID-19 mRNA vaccine and expand to the global market.
A newly developed messenger RNA vaccine is the first such approach to elicit acquired resistance against the tick Ixodes scapularis and prevent it from transmitting the Lyme disease vector Borrelia burgdorferi in guinea pigs, according to a U.S. study led by researchers at Yale University School of Medicine in New Haven, Conn.
Baidu Inc.’s preclinical studies showed the mRNA vaccine sequences for COVID-19 designed using its Lineardesign algorithm outperformed the benchmark sequences designed by traditional algorithms in terms of stability, protein expression and immunogenicity. The firm teamed up with Stemirna Therapeutics Co. Ltd., which specializes in the R&D of mRNA vaccines and drugs, to test seven mRNA COVID-19 vaccine sequences designed using Lineardesign.
Celltrion Inc. is riding high after receiving full approval for Regkirona (regdanvimab), as a treatment for COVID-19 in South Korea, seven months after the Ministry of Food and Drug Safety (MFDS) granted it conditional marketing approval in February 2021.
In a couple of deals worth more than $500 million, Everest Medicines Ltd. is picking up Asian rights to Providence Therapeutics Holdings Inc.’s mRNA candidates, including rights to a mRNA COVID-19 vaccine candidate currently in phase II testing.
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity.
With the Americas having the dubious distinction of the most COVID-19 cases in the world, the Pan American Health Organization (PAHO) is answering that “wake-up call” with plans to develop a collaborative platform to develop mRNA vaccine production in Latin America and the Caribbean.
The CDC’s Advisory Committee on Immunization Practices (ACIP) deliberated the matter of third COVID-19 shots, with panel members voting whether to recommend “additional doses of mRNA COVID-19 vaccines as part of a primary [two-shot] series” in certain immunocompromised patients. A work group set up by ACIP decided previously that the desirable consequences outweighed undesirable ones in such a population.
Mcurex Therapeutics Inc. will work with Samyang Holdings Corp. to develop an mRNA vaccine for COVID-19, advancing its bid to become the first Korean company to do so.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
