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ESMO 2022: the evolution of TIL therapy – a highly promising approach

Pharmaceutical Technology

Successful TIL therapy depends on the infusion product containing tumour-reactive T cells that, on infusion, generate an anti-tumour immune response that causes disease regression. The use of engineered immune cytokines that selectively induce the expansion of TILs is being investigated as an alternative to IL-2 stimulation.

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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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EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine

pharmaphorum

Last month, interim results from a phase 1/2 trial of ChAdOx1 were published in The Lancet and showed the jab was tolerated and generated immune responses against the SARS-CoV-2 virus in all vaccinated participants.

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Flow cytometry: advantages in immunotherapy clinical trials

Pharmaceutical Technology

More than three decades ago, scientists at the National Cancer Institute began exploring ways to fight cancer using the patient’s immune system. The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1%

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Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Pfizer Disclosure Notice.

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Understanding the microbiome as an ‘overlooked critical organ’

pharmaphorum

As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system. The possibilities. Compelling advantages.

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COVID prompts another milestone, as India clears first DNA vaccine

pharmaphorum

DNA vaccines work by delivering a genetically-engineered plasmid containing the DNA sequence encoding the desired antigen – in this case the SARS-CoV-2 spike protein – which is then taken up by cells. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

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