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US FDA grants Fast Track status for Pfizer-BioNTech’s combination vaccine

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. 5 Omicron sublineages spike proteins.

Vaccines 115
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RVAC and University of Pennsylvania to develop mRNA vaccines

Pharmaceutical Technology

RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The mRNA vaccine candidates will help reduce the chances of autoimmune responses that might lead to allergic conditions or serious autoimmune diseases.

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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. The post GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA appeared first on Pharmaceutical Technology.

Vaccines 115
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The one-shot cervical cancer vaccine paradigm

Pharmaceutical Technology

On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage. Several cervical cancer vaccines are currently approved, including Merck’s nonavalent vaccine Gardasil 9 and GSK’s bivalent vaccine Cervarix.

Vaccines 116
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US FDA grants breakthrough therapy designation for Moderna’s RSV vaccine

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. The investigational mRNA-1345 vaccine uses the same lipid nanoparticles (LNPs) that are also used in the Moderna Covid-19 vaccines.

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China’s NMPA grants EUA to CSPC Pharmaceutical’s Covid-19 vaccine

Pharmaceutical Technology

China’s National Medical Products Administration (NMPA) has granted emergency use authorisation (EUA) for CSPC Pharmaceutical Group’s messenger RNA (mRNA) vaccine, SYS6006, to treat Covid-19. With this regulatory approval, CSPC Pharmaceutical is claimed to be the first company to receive approval for providing an mRNA vaccine in the country.

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UTMB and HDT Bio receive US funding for vaccine development

Pharmaceutical Technology

in a project agreement from the US government for developing self-amplifying RNA (saRNA) vaccine technology against advanced and emergent viral threats. Development of vaccines to Phase I trials under the five-year $59m prototype project comprises additional $28.4m in milestone payments.