Remdesivir is the only USFDA approved Emergency Use Authorisation (EUA) treatment for covid-19

The Homegrown pharma major Cipla Ltd announced the launch of its generic version of remdesivir. It has been authorised for emergency use in treatment of COVID-19 patients by the USFDA, under its brand name Cipremi. The USFDA had issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc for emergency use of the drug for the treatment of COVID-19 patients.

Remdesivir is the only USFDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients who are hospitalised with suspected or laboratory confirmed COVID-19 infection.

In May, Gilead Sciences Inc, extended a voluntary non-exclusive license to Cipla pharmaceuticals to manufacture and market generic version of remedisvir called Cipremi.

Cipla said it has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need in the country.

Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients, as a part of risk management plan.

 
To enable speedy and equitable access to this drug of interest and in anticipation of demand, Cipla will be commercialising remdesivir through its own facilities and partnered sites.

The drug will be supplied through the government and open market channels of country to ensure equitable distribution.

Commenting on the launch, Cipla Ltd MD and Global CEO Umang Vohra said, "Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by COVID-19 pandemic, and this launch is a significant milestone in that direction".

The company will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with the belief that no patient should be denied access to life-saving treatments, he added.

Glenmark Pharmaceuticals Ltd launches a drugs for COVID-19 -Fabi flu

Glenmark Pharmaceuticals Ltd launches a drugs for COVID-19, and would begin a clinical trial in India to test a combination of these two anti-viral drugs, favipiravir and umifenovir, as a potential treatment.

In present situation, all over the world is in search of vaccine and medication to fight back against the corona virus, which has infected 5.5 million people globally, killing more than 345,000, according to a Reuters tally. In India, now among the 10 most affected nations, the death toll reached 4,167. And the success of this trial would take Glenmark pharmaceutical to next level and world will get a breathe of relief.

Glenmark has been successful in securing the approval of Indian regulatory for conduct of the study. The study will aim to enroll 158 hospitalized patients with moderate COVID-19. 

Favipiravir is made under the brand name Avigan by Japan's Fujifilm Holdings Corp and was approved for use as an anti-flu drug in 2014 in Japan, while umifenovir is licensed as a treatment for some types of flu infections in Russia and China.

Generics drugmaker Beximco (AIM: BXP and fellow Bangladesh-based Beacon Pharmaceuticals have developed version of favipiravir. Although the drug is patented in Japan, according to Beximco, Bangladesh could market and produce favipiravir until 2033 under the relaxed guidelines of the World Trade Organization (WTO).

Glenmark is also conducting clinical trials in India of just favipiravir as a potential COVID-19 treatment, for which it expects results by July or August. However Favipiravir is also undergoing trials in other countries.

These two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy, the Mumbai-headquartered drugmaker stated.

Another Indian drugmaker - Strides Pharma - is also set to begin clinical trials of favipiravir as a potential COVID-19 treatment.

Shares in Indian drugmakers have been on a tear this year. India's Nifty pharma index has risen 18% this year, compared with a 26% slide in the blue-chip NSE Nifty 50.

But still the question remains the same, will the drug prove itself efficacious, and will we be able to find the treatment, and will the world find peace again from this pandemic?

Note: This news is confirmed by Economic times India.

https://health.economictimes.indiatimes.com/news/pharma/glenmark-pharma-to-study-potential-covid-19-drug-combination/76004935

COVID-19 vaccine development is getting closer to success in India

In new delhi, Scientists have identified regions of the SARS-CoV-2 virus that causes COVID-19 to target with a vaccine, by harnessing tools used for the development of cancer immunotherapies. The researchers at Children's Hospital of Philadelphia (CHOP) in the US employed the same approach used to elicit an immune response against cancer cells to stimulate an immune response against the novel coronavirus.

Using this strategy, the researchers believe a resulting vaccine would provide protection across the human population and drive a long-term immune response.

"In many ways, cancer behaves like a virus, so our team decided to use the tools we developed to identify unique aspects of childhood cancers that can be targeted with immunotherapies and apply those same tools to identify the right protein sequences to target in SARS-CoV-2," said John MMaris, a pediatric oncologist at CHOP, and a professor at the University of Pennsylvania.

"We think our approach provides a roadmap for a vaccine that would be both safe and effective and could be produced at scale," said Maris, senior author of the research published in the journal Cell ReportsMedicine.

The COVID-19 pandemic has led to an urgent need for the development of a safe and effective vaccine against SARS-CoV-2, the virus that causes the COVID-19 disease, the researchers said.

An optimally designed vaccine maximises a long-lasting immune response, while minimising adverse reactions, autoimmunity, or disease exacerbation, they said. To increase the likelihood that a vaccine is both safe and effective, the research team prioritised parameters in identifying regions of the virus to target.

The researchers looked for regions that would stimulate a memory T-cell response that, when paired with the right B cells, would drive memory B cell formation and provide lasting immunity and do so across the majority of human genomes.

They targeted regions of SARS-CoV-2 that are present across multiple related coronaviruses, as well as new mutations that increase infectivity, while also ensuring that those regions were as dissimilar as possible from sequences naturally occurring in humans to maximize safety.

The researchers propose a list of 65 peptide sequences that, when targeted, offer the greatest probability of providing population scale immunity.

The team will now test various combinations of a dozen or so of these sequences in mouse models to assess their safety and effectiveness.

Note: The above news is confirmed by newspaper, Economic Times, India.

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