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

Pharmaceutical Technology

The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1)

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

Camargo

An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

And we are very prepared and have data that will answer those questions, what would be the advantage of shifting to an Omicron-containing vaccine, whether it's monovalent or bivalent.” Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen.

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Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

XTalks

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. Developed by Eisai and Biogen, Leqembi is an amyloid beta-directed antibody.

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The democratisation of cell and gene therapy

Drug Discovery World

Marc Hummersone, Senior Director of Research and Development (R&D) at Astrea Bioseparations, shares insight on the challenges and opportunities in cell and gene therapy (CGT) with DDW’s Megan Thomas. But the unpacked capsid can give rise to an immune response, which is not good for the patient.

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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

This is because there are thousands of genes in malaria parasites compared to only about a dozen or so in coronaviruses. Moreover, a very strong immune response is needed to fend off the disease. That’s a real technical challenge,” said Hill, “The vast majority of vaccines haven’t worked because it’s very difficult.”.

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Synlogic Announces Advancement of SYNB1891 to Combination Arm Dosing with PD-L1 Checkpoint Inhibitor in the on-going Phase 1 Study for the Treatment of Solid Tumors and Lymphoma

The Pharma Data

SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response. Synlogic’s President and Chief Executive Officer.