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- Read more about CDSCO extended validity of WHO GMP/Certificate of Pharmaceutical Product for six months
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.
- Read more about FDA nods nivolumab with ipilimumab as first line treatment of metastatic non-small cell lung cancer
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.
- Read more about FDA grants priority review of Sanofi’s biologics license application for sutimlimab
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.
17 May 2020

Heart attacks, heart failure, stroke: COVID-19's dangerous cardiovascular complications

COVID-19 can cause serious cardiovascular complications including heart failure, heart attacks and blood clots that can lead to strokes, emergency medicine doctors report in a new scientific paper. They also caution that COVID-19 treatments can interact with medicines used to manage patients' existing cardiovascular conditions.
17 May 2020

US based Sorrento Therapeutics claims breakthrough against COVID-19, shares jumps around 244 percent

San Diego based Sorrento Therapeutics claims that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration which lead to jumps in stocks around 244%.
16 May 2020

Antiviral drug can speed up recovery of COVID-19 patient : Research

An international team of researchers led by Dr. Eleanor Fish, emerita scientist at the Toronto General Hospital Research Institute, University Health Network, and professor in the University of Toronto's Department of Immunology, has shown for the first time that an antiviral drug can help speed up the recovery of COVID-19 patients.
16 May 2020

Zydus Cadila receives tentative approval from USFDA for Droxidopa Capsules

Zydus Cadila has received tentative approval from the USFDA to market Droxidopa Capsules, (US RLD: Northera®) in the strengths of 100 mg, 200 mg, and 300 mg.
14 May 2020

18 approved and investigational Pfizer medicines to be showcased

Pfizer Inc announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO20 Virtual Scientific Program, from May 29-May 31. The data that will be presented build on Pfizer’s strong track record in oncology by providing new insights in areas like breast, colorectal and genitourinary cancers, which include bladder, prostate, and kidney cancer.
- Read more about New project to develop human monoclonal antibodies for neutralizing SARS-CoV-2
The Council of Scientific and Industrial Research (CSIR), through its New Millennium Indian Technology Leadership Initiative (NMITLI) program, has approved a project towards development of human monoclonal antibodies (hmAbs) that can neutralize SARS-CoV-2 in patients. This project on generation of neutralizing human monoclonal antibodies as a therapeutic strategy will be implemented by a multi-institutional and multi-disciplinary team.
- Read more about Gilead permits Cipla for manufacturing and distribution of Remdesivir
Cipla Limited announced that it has signed a non-exclusive licensing agreement with Gilead Sciences, Inc. for the manufacturing and distribution of the investigational medicine Remdesivir, which has been issued an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to treat COVID-19 patients. This agreement is part of Cipla’s efforts to enhance global access to life-saving treatments for patients affected by the pandemic.