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Spain reports 1st case of Zika-related microcephaly

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Health authorities in Catalonia, northeast Spain, have reported the country’s first known case of the microcephaly birth defect in the fetus of a pregnant woman infected with the Zika virus, AFP reported.

A total of 105 people in Spain have been infected with the mosquito-borne Zika virus, according to official statistics as of May 3. Authorities say all the infection cases – including 13 pregnant women – were “imported cases” found in people either “from, or who have visited affected countries” in Latin America.

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Only supporting, not a key player in Maharashtra: Rahul

The Governor followed it up by a review meeting of the crisis in which Thackeray excused himself but sent his close confidante Milind Narvekar.

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Rahul Gandhi

New Delhi, May 26 : Amid allegations of mishandling the covid crisis in Maharashtra by opposition leaders who even demanded dismissal of the state government, Congress leader Rahul Gandhi said that his party is not a key player in running Maharashtra government.

The Congress is part of “Maha Vikas Aghadi” and holds key ministries but Rahul Gandhi said, “We are only supporting the government and are not a ‘key player’ in the state”.

Rahul Gandhi, however, defended the state government and said that Mumbai is a well connected state. and that is the reason why Covid cases are rising there.

Rahul Gandhi asserted that the party is doing better where ever it is running its own government.

Rahul Gandhi’s statement could be a setback for MVA government in Maharashtra where hectic politics is going on. NCP chief Sharad Pawar met the governor on Monday, though all speculations were rejected by Shiv Sena MP Sanjay Faut on Tuesday.

Tongues started wagging as Nationalist Congress Party President Sharad Pawar went to meet Governor Bhagat Singh Koshyari at Raj Bhavan, in what was described by both sides as a “courtesy call”.

Accompanied by NCP MP Praful Patel, this was Pawar’s first-ever meeting with the Governor who was appointed in September 2019, crowning a series of recent political developments in the state.

Later on Monday afternoon, it was the turn of BJP leader and former Chief Minister Narayan Rane to meet the Governor and reportedly demanded imposition of President’s rule in the state.

Among various things, Rane has claimed the government headed by Chief Minister Uddhav Thackeray had failed to handle the Covid-19 pandemic crisis in the state.

Rane’s demand came days after Leader of Opposition Devendra Fadnavis called on Koshyari and complained that the Thackeray government had bungled in handling the coronavirus situation.

The Governor followed it up by a review meeting of the crisis in which Thackeray excused himself but sent his close confidante Milind Narvekar.

A couple of days later, Koshyari raised strong objections to a letter written by Minister of Higher and Technical Education Uday Samant to the UGC recommending cancellation of final year university examinations, which the Governor pointed out was against the guidelines.

This was followed by Sena MP Sanjay Raut calling on the Governor, and a day later, Thackeray announced that the lockdown implemented suddenly was not proper, and lifting it abruptly would be detrimental to the people.

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Glenmark to start trial combining 2 anti-viral drugs on India Covid patients

Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests for COVID-19 based on RT-PCR.

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remdesivir antiviral drug

New Delhi, May 26 : Glenmark Pharmaceuticals announced on Tuesday that it will commence another new Phase 3 clinical trial on a combination of two anti-viral drugs Favipiravir and Umifenovir in hospitalized patients of moderate COVID-19 in India.

Glenmark has received approval from the Indian regulator to initiate the study.

The combination study which will be called the FAITH trial will look to enroll 158 hospitalized patients of moderate COVID-19 in India.

Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening duration of virus shedding, decreasing cytokine response, and facilitating early discharge of patients.

Glenmark said the antivirals with different mechanisms of action could complement and enhance efficacy against COVID-19.

Glenmark also continues its Phase 3 clinical trials on antiviral Favipiravir monotherapy for COVID-19 patients in India.

The company has announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment strategy.

The two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease.

Early administration of a combination of antiviral medications acting by different mechanisms is desirable for the treatment of COVID-19, since the viral load of SARS-CoV-2 peaks around the time of symptom onset.

Thus combining antiviral drugs could result in greater clinical effectiveness and could also prevent, or delay, the emergence of resistance.

Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action by which it inhibits viral replication.

It is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity that is required for viral replication.

Umifenovir is another oral antiviral drug licensed for the treatment and prophylaxis of influenza A and B infections in Russia and China.

Umifenovir impedes the viral attachment to cells and acts as a viral entry inhibitor. Additionally it exhibits modulatory effects on the immune system and induces interferon-production.

Hence a combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle ofthe SARS-CoV-2virus.

Both Favipiravir and Umifenovir inhibitedvirus infection invitro6and have shown efficacy in COVID-19 clinical trials.

The current Glenmark study will examine whether early administration of a combination of Favipiravir and Umifenovir, both acting by different mechanisms, enhances antiviral efficacy on COVID-19patients.

Commenting on this development, Vice President & Head Clinical Development Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd., Monika Tandon, said: ” Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to overall improvement in clinical parameters. We consider Glenmark’s study will be pivotal in leading to identification of highly effective and safe treatments against COVID-19 in India. Beyond its many potential patient treatment benefits, we also hope the combination therapy will reduce infection risk amongst medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients.”

Further, Sujesh Vasudevan, President, India Formulations, Middle East and Africa business, Glenmark Pharmaceuticals Ltd. mentioned “This is another step in our effort is to launch a treatment for COVID-19 patients and we are looking at every possibility. We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful.”

The new combination clinical trial will be called FAITH-(FAvipiravir plus Um Ifenovir (efficacy& safety) Trial in IndianHospitalsetting). A total of 158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized in two groups : one group receiving Favipiravir and Umifenovir (with standard supportive care); and one group receiving Favipiravir along with standard supportive care.

Patients in the arm receiving the drug will receive Faviprivir 1800mg bid and Umifenovir 800 mg bid on Day1. Thereafter patients would receive Faviprivir 800mg bid and Unifenovir 800mgbid for the remaining course of the treatment.

Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests for COVID-19 based on RT-PCR.

Simultaneously Glenmark is also conducting phase 3 clinical trials of Favipiravir asa COVID-19monotherapy option with 150 patients, enrolled from 9 leading government and private hospitals across the country.

So far 30 patients have been randomised. The monotherapy phase3 clinical trial results are expected by July/August 2020. Glenmark was the first pharmaceutical company to receive approval from drug regulator DCGI to conduct Favipiravir clinical trials against COVID-19 in India.

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After Gowda episode, Karnataka exempts ministers, officials from quarantine

Gowda, a Lok Sabha member from the Bangalore North constituency, flew into the city in a commercial flight on the first day of resumption of domestic services after 63 days of lockdown.

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Sadananda Gowd

Bengaluru, May 25 : The Karnataka government exempted Union and state ministers and officials from quarantine, which it made mandatory for all entering the state from other states or overseas to contain the Covid-19 outbreak, a top official said on Monday.

“The ministers of Union government or state governments or officers on duty will be exempted from quarantine as has been done for health professionals,” said state Health Commissioner P.K. Pandey in an order here.

The order has also exempted any person who gets a Covid negative test certificate from an ICMR approved lab which is not more than 2 days old from the date of journey, from institution quarantine.

The order has also exempted airlines crew on official duty from quarantine.

The order came on a day when Union Minister for Chemicals and Fertilisers D.V. Sadananda Gowda was allowed to exit the airport on arriving from New Delhi without going into 7-day institutional quarantine, as other passengers who too came from the national capital, which is one of the 6 most Covid-hit states in the country.

Gowda, a Lok Sabha member from the Bangalore North constituency, flew into the city in a commercial flight on the first day of resumption of domestic services after 63 days of lockdown.

“I am exempted under the clause by the state government as well as the Central government,” Gowda told a local news channel when asked how he could avoid the mandatory quarantine on landing from Delhi.

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