Remove Clinical Trials Remove Immune Response Remove Manufacturing
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IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

XTalks

The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. 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% efficacy at six months and 98.8%

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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

These large, complex molecules are made inside living cells, which can lead to small variations in the manufacturing methods that can have a significant impact on the final product. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.

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How did pharma develop a vaccine so quickly?

World of DTC Marketing

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. Then there are the finances.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) 1) versus the 50µg mRNA-1273 booster dose.

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Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial.

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Intravacc gets NIAID contract for intranasal gonorrhoea vaccine development

Pharmaceutical Technology

Intended for intranasal administration, NGoXIM was demonstrated to be effective in animal models and elicited a durable and cross-protective immune response in proof-of-concept (PoC) studies. . This trial will evaluate the safety of the vaccine and generate efficacy data.

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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. It has been developed using the company’s recombinant nanoparticle technology.