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WuXi Biologics received GMP certification from ANVISA.

WuXi Biologics recently announced that it has received the Good Manufacturing Practice (GMP) certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA). The positive results from ANVISA declare the company’s strong commitment to offering partners a global manufacturing network of the highest standard.

This will be WuXi Biologics’ third GMP certification from the drug regulatory authorities and distinguishes it as the first company in China to receive authorizations from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and ANVISA to manufacture biologics. In total, the company has passed six GMP inspections.

(Source: PR News Wire, 2021)

U.S. Renal Care to Use Monoclonal Antibody Therapy to Treat COVID-19 Patients

The U.S. Renal Care (USRC) recently announced its plans to obtain and distribute Bamlanivimab, a monoclonal antibody therapy to patients recently diagnosed with COVID-19.

USRC obtained the therapy from Operation Warp Speed, Project SPEED, and will administer the drug to medically stable COVID-19 positive patients with mild to moderate disease in their outpatient dialysis facilities.

Bamlanivimab, manufactured by Eli Lilly and distributed by AmerisourceBergen, has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 for non-hospitalized patients aged 12 years old and above. The therapy must be given as an intravenous (IV) infusion within ten days of detected symptoms after a positive COVID-19 test.

(Source: PR News Wire, 2021)

Vir and GSK Doses Its First Patient in its COVID-19 Monoclonal Antibody Trial. 

Vir Biotechnology and GlaxoSmithKline (GSK) have recently dosed its first patient in a new sub-trial of a Phase III study assessing the monoclonal antibody VIR-7831 as a potential treatment for the novel COVID-19 virus.

The study is part of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program. The ACTIV-3 clinical trial will assess the safety and efficacy of VIR-7831 in patients with the COVID-19 virus. 

VIR-7831 is an investigational monoclonal antibody that was selected based on its potential to neutralize the virus, as well as provide a high barrier to resistance and achieve high concentrations in the lungs. It is also currently being evaluated in Phase II/III COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early trial for the early treatment of COVID-19 of adults at high risk.

(Source: BioSpace, 2021)