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Celltrion’s Avtozma Receives FDA Approval, Making it the Third Actemra Biosimilar to Hit the Market

XTalks

The FDAs decision was based on comprehensive data demonstrating biosimilarity between Avtozma and the reference product, Actemra. That was followed by a full approval for the same patient subset in December 2022, making it the first FDA-approved monoclonal antibody to treat COVID-19.

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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. It can suppress Th2 immune responses by binding to IL-17RB on Type 2 innate lymphoid cells (ILC2s).

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Team studies immune response, proteins in blood of young adults who develop rare complication after COVID vaccination

Medical Xpress

In a new study by researchers from Mass General Brigham's founding members, Brigham and Women's Hospital and Massachusetts General Hospital, a team extensively investigated the immune response of 16 adolescents and young adults who developed myocarditis after receipt of the COVID mRNA vaccine.

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

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1) versus the 50µg mRNA-1273 booster dose. 1 variant as well as the original 2020 strain.”.

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Genmab and argenx team up to engineer novel antibody therapies

Pharmaceutical Technology

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas.

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

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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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.

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