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Early data shows Russia’s Sputnik V COVID-19 vaccine produces immune response

pharmaphorum

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. All participants in the phase 2 trials (40 participants) produced antibodies against the SARS-CoV-2 spike protein.

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World Pneumonia Day 2024: New Treatments and Innovations

XTalks

Thus, to address drug-resistant infections, pharma and biotech companies are developing novel treatments such as bacteriophage therapies, immunomodulators and monoclonal antibodies. Monoclonal Antibody Therapies Monoclonal antibodies are gaining traction as targeted treatments for bacterial and viral infections.

Bacteria 110
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Rapid COVID immune status test launched in UK, Ireland

pharmaphorum

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

Antibody 137
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J&J single-shot COVID-19 vaccine shows early promise

pharmaphorum

Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years. J&J expects to file with the FDA first, followed by other regulators.

Vaccine 119
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Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO  

Worldwide Clinical Trials

This year, Matt Cooper, PhD , our Executive Director, Therapeutic Strategy Lead, Oncology, attended and found the presentations around antibody-drug conjugates (ADCs) and tumor-infiltrating lymphocytes (TILs) to be of great interest to the future of oncology therapeutics.

Antibody 162
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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. CBER regulates products under a variety of regulatory authorities: INDs for CBER-regulated products. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

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South Korea authorises Novavax Covid-19 vaccine as booster dose

Pharmaceutical Technology

The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinical trials. Nuvaxovid demonstrated a significant antibody response when given as a booster dose after primary vaccination with other authorised Covid-19 doses in the COV-BOOST trial.

Vaccine 147