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.
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.
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.
COVID-19, the disease caused by coronavirus SARS-Cov-2, has infected over 4 million people in 212 countries, of whom at least 272,000 have died. The ongoing economic and social impact of the pandemic is staggering, but despite a daily flood of news on the disease, few laypeople know that paradoxically, COVID-19 mostly kills through an overreaction of the immune system, whose function is precisely to fight infections.
For the first time, using a mouse model of Alzheimer's disease, scientists have documented a link between raised levels of calcium in mitochondria and neuronal death in the living brain. This relationship was previously documented in cell culture, but seeing this phenomenon in living mice makes it more likely that this occurs in people also and could point to a new target for Alzheimer's disease.
“The Union Minister of Science and Technology, Earth Sciences, and Health and Family Welfare, Dr. Harsh Vardhan said today that India’s fight against the COVID-19 is moving fast ahead strongly and steadily. He was addressing a digital conference, RE-START – ‘Reboot the Economy through Science, Technology and Research Translations’, organized to celebrate the National Technology Day. The Conference was organized by the Technology Development Board (TDB), a statutory body of the Department of Science and Technology (DST) and the Confederation of Indian Industry (CII).
U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.
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