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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.

Vaccine 245
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Meningitis vaccine comes to the forefront with impressive study results

Pharmaceutical Technology

The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK. for serogroup W to 20.5

Vaccine 195
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Chinese tech giant Baidu licenses mRNA algorithm to Sanofi

pharmaphorum

Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. The post Chinese tech giant Baidu licenses mRNA algorithm to Sanofi appeared first on.

Licensing 105
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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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AbbVie preps filings for lymphoma bispecific licensed from Genmab

pharmaphorum

Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immune response against the cancer. The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on. billion product at peak.

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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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There is a large pipeline of CAR-T cell therapies for diffuse large B-cell lymphoma

Pharmaceutical Technology

The concept behind this form of treatment is that the introduction of these cells will enhance the immune response to disease, often through bioengineering the immune cells to have improved functionality and characteristics, such as longer half-lives. Overall, the global CAR-T cell market for all indications was worth $1.7