Moderna, Inc., a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
New research from CSHL scientists suggests that cigarette smoke spurs the lungs to make more ACE2 (angiotensin-converting enzyme 2), the protein that the coronavirus responsible for COVID-19 grabs and uses to enter human cells. The findings, reported May 16, 2020 in the journal Developmental Cell, may explain why smokers appear to be particularly vulnerable to severe infections. The analysis also indicates that the change is reversible, suggesting that quitting smoking might reduce the risk of a severe coronavirus infection.
Patients infected with either severe acute respiratory syndrome coronavirus (SARS-CoV) or SARS-CoV-2 produce antibodies that bind to the other coronavirus, but the cross-reactive antibodies are not cross protective, at least in cell-culture experiments, researchers report May 17 in the journal Cell Reports. It remains unclear whether such antibodies offer cross protection in the human body or potentiate disease. The findings suggest that more research is needed to identify parts of the virus that are critical for inducing a cross-protective immune response.
Central Drugs Standard Control Organisation (CDSCO) extends validity of WHO GMP/CoPP expiring from March to August 2020 by 6 months due to COVID-19 outbreak in the country.
The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s.
Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
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