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Latest From Moderna, Inc.

Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Advisors Intrigued by Novavax As Booster

Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.

Coronavirus COVID-19 Vaccines

SK Bioscience First To Line In Korea COVID Vaccine Race

SK Bioscience has received the world’s first approval of its in-house developed recombinant protein COVID-19 vaccine SKYCovione (GBP510), in its home market of South Korea, two years after it began development. Strong support from the domestic government and international cooperation helped pave the way.

South Korea Approvals

ReCode Raises Another $120m To Broaden LNP Delivery Of Genetic Medicines

The company’s lipid nanoparticle technology can deliver mRNA, gene editing and other cargoes to multiple cell and organ types. ReCode aims to expand its pipeline beyond lung diseases.

Financing Business Strategies

Operation Warp Speed For Rare Diseases? US FDA Is Considering Pilot Programs

CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.

Gene Therapy Rare Diseases
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    • Caperna LLC
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