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Drug made from pig intestine helps escape the “trap” of clot-causing immune response

Scienmag

When the body attempts to fight off an infection, immune cells called neutrophils may shoot out spider web-like networks of toxic proteins to help contain the invaders.

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

Camargo

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. 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.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen. 1 sub-lineage on 19 July.

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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial. At six months, 29.5 Changing the Face of Malaria.

Vaccine 105
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FDA fast-tracks Leap’s gastric cancer immunotherapy

pharmaphorum

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

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AZ resumes trial of COVID-19 vaccine

The Pharma Data

On September 6 the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators, after one trial volunteer experienced an unexplained illness. Source link.

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Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults. Immune Response Data.