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Home » mRNA vaccines

Articles Tagged with ''mRNA vaccines''

Celltrion wins full approval for COVID-19 treatment in South Korea

Sep. 20, 2021
By Gina Lee
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.
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Deal handshake with graphic overlay

Everest adds mRNA candidates to pipeline in deals with Providence worth $500M+

Sep. 14, 2021
By Doris Yu
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.
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Eyegene-hero-pic-9-7

Eyegene cleared to begin phase I/IIa trial for mRNA COVID-19 vaccine in South Korea

Sep. 7, 2021
By Gina Lee
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.
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Pharmaceutical manufacturing

Tired of waiting for vaccines, PAHO proposes making its own

Aug. 26, 2021
By Mari Serebrov
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.
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‘Third’ party: ACIP backs FDA move to add COVID-19 shot for some

Aug. 13, 2021
By Randy Osborne
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.
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Mcurex joins race to develop first South Korean mRNA vaccine with Samyang

June 17, 2021
By Gina Lee
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.
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Regulatory front for April 7, 2021

April 7, 2021
By Mark McCarty
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.
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Regulatory front for March 30, 2021

March 30, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, other stent graft products in line for FDA panel safety probe; New conditions imposed on vaccine authorization; MRNA vaccine efficacy holds in real world; STIs on the rise in U.S.
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Curevac allies with Bayer in COVID-19 vaccine push

Jan. 7, 2021
By Cormac Sheridan
DUBLIN – Curevac AG has entered a global alliance with Bayer AG to accelerate its efforts to bring a third, desperately needed mRNA-based COVID-19 vaccine to market. The vaccine in question, CVnCoV, began a pivotal phase IIb/III trial on Dec. 14.
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mRNA COVID-19 vaccines to usher in ‘golden age of vaccinology’

Dec. 8, 2020
By Cormac Sheridan
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
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