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IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

XTalks

IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus. The study included 754 adolescents, comparing immune responses and safety profiles between vaccine and placebo groups. These sustained responses build on earlier data showing 99.1%

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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

They intend to develop vaccines that provide lasting immune responses compared to existing vaccines. In March, the company entered a licensing agreement with Serum Institute of India (SII) to expedite access to messenger RNA products in emerging markets worldwide.

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Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech

pharmaphorum

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. Soon-Shiong said that oral vaccines could have another key advantage as they stimulate mucosal, systemic and T-cell immune responses. “As

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Evaxion and ExpreS²ion partner to develop new CMV vaccine

Pharmaceutical Technology

Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN. According to the agreement, ExpreS 2 ion will hold the exclusive right for licensing the CMV vaccine candidate under a possible development and commercialisation agreement.

Vaccine 130
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South Korea authorises Novavax Covid-19 vaccine as booster dose

Pharmaceutical Technology

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

Vaccine 147
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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Monkeypox vaccine: First EUA for Bavarian Nordic amid worldwide shortages

Pharmaceutical Technology

A 2015 study showed that both routes of administration (ROA) produce similar immune responses but that intradermal ROA produced more swelling at the injection site.) On July 26, 2022, the FDA extended the biologics license for Jynneos to allow for additional manufacturing at one of Bavarian Nordic’s plants. See Table 1).

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