
Application are invited for Pharmacist under National Health Mission, Malegaon Municipal Corporation for handling corona virus (Covid-19) the outbreak situation.
Post : Pharmacist

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.
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.
Monoclonal antibody therapy is a form of immunotherapy designed to produce immunity to a disease or to enhance resistance by the immune system. This new project aims to generate hmAbs to SARS-CoV-2 from gradual recovery phase of COVID-19 patients and select high affinity and neutralizing antibodies. The project also aims to anticipate future adaptation of the virus and generate hmAbs clones that can neutralize the mutated virus so that could be readily used for combating future SARS-CoV infections.
This new project aims to generate hmAbs to SARS-CoV-2 from gradual recovery phase of COVID-19 patients and select high affinity and neutralizing antibodies.
This industry-academia collaboration comprises National Centre for Cell Science (NCCS) Pune; Indian Institute of Technology (IIT), Indore; PredOmix Technologies Ltd, Gurugram; and Bharat Biotech International Ltd (BBIL), Hyderabad. Vaccines and biotherapeutics maker BBIL is leading the project to develop human monoclonal antibodies (hmAbs) for COVID-19 infection. BBIL will be the commercial partner and responsible for subsequent development and commercialization of the hmAbs generated.
DG-CSIR, Dr Shekhar C Mande commented that “As the research into SARS-CoV-2 is in early days and our understanding is evolving each day, it is critical that we deploy all possible strategies to combat the virus. Hence, CSIR is exploring all avenues and we are supporting new ideas which have clear deployment strategy”.
CSIR is leading the fight against COVID-19 using multi-pronged approach and multiple models of engagement. CSIR labs themselves are developing technologies and products and are working with industry and public sector undertakings for deployment. NMITLI is a flagship program of CSIR aimed to support new ideas and projects from academic institutions and industries.
- India Science Wire
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.
As part of the agreement, Cipla will be permitted to manufacture the API and Finished product, and market it in 127 countries including India and South Africa under Cipla’s own brand name. Cipla will receive the manufacturing know-how from Gilead Sciences, Inc. to manufacture the API and Finished product at a commercial scale. Cipla’s extensive geographical and commercial footprint will help make this therapy accessible to more patients and markets.
According to the World Health Organisation (WHO)’s tracker, the number of reported COVID-19 cases has crossed the four million mark globally.
The EUA will facilitate broader use of Remdesivir to treat hospitalized patients with severe symptoms of COVID-19. The EUA is based on available data from two global clinical trials – US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global Phase 3 study evaluating Remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of Remdesivir as a potential treatment for COVID-19. Remdesivir continues to be an investigational drug that has not been approved by the FDA.
Commenting on the partnership, Mr. Umang Vohra (MD and Global CEO, Cipla Limited) said, “As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together. We are pleased to partner with Gilead for this cause and take this treatment to patients across countries after the required regulatory approvals. At Cipla, it is our continuous endeavour to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic.”