Remove Antibody Remove Packaging Remove Protein
article thumbnail

US FDA accepts Sandoz’s BLA for biosimilar denosumab

Pharmaceutical Technology

The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein. The BLA submission is supported by a comprehensive analytical and clinical data package, including the Phase I/III ROSALIA trial data.

Packaging 130
article thumbnail

CanSinoBIO developed a highly effective COVID vaccine with an inhalant version

pharmaphorum

. “It is programmed and coded for the production of the full-length spike protein of the coronavirus. It then elicits an immune response against that spike protein. You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA approves GSK’s Blenrep for advanced multiple myeloma

pharmaphorum

Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly found on the surface of the malignant B-cells that cause the disease.

article thumbnail

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

article thumbnail

Brochure: Dynabeads manual and automated SARS-CoV-2 enrichment

The Pharma Data

The vast majority of current laboratory testing for COVID-19 is based either on detection of viral antigens, nucleic acids or on detection of virus-specific antibodies in the sera of patients. Detection of virus-specific antibodies allows for diagnosis of recent symptomatic or even asymptomatic infections.

Protein 52
article thumbnail

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

(NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells.

article thumbnail

China’s ‘insect’ vaccine for COVID-19 approved for human testing

The Pharma Data

It is hoped that using insect cells to grow proteins for the vaccine could speed up large-scale production. The National Medical Products Administration has granted approval to the West China Hospital of Sichuan University in Chengdu to begin a clinical trial. Conor Kavanagh.