PHARMA LITERATI

Largely opaque and proprietary R&D environments in the life sciences sector need to make way for strategies facilitated by sustainable investment models, open sourcing and multi-lateral partnerships, to deal with a growing threat from infectious/zoonosis diseases “There are decades where nothing happens, and there are weeks where decades happen.” These words by Russian revolutionary, Vladimir Lenin describe the current scenario to a ‘T’. Most of us have seen more disruptions over the last few weeks than probably ever before in our lifetime, especially if one is a millennial or younger. Yet, these times are also a watershed in terms of the lessons for mankind. The impact and implications of the coronavirus pandemic will shape new norms and mindsets, approaches and agendas worldwide for a long time to come. Hopefully, it will also usher a more cohesive approach to the way we practise and publish scientific research. Because it is critical, especially in the life science...

Dr Sangita Reddy, President, FICCI announced the launch of ‘Virtual Healthcare and Hygiene Expo 2020’ (VH&H Expo 2020) – India’s first International virtual exhibition and conference organized by FICCI from 22-26 June 2020. This is the first time that an event will be organised on virtual platform and digitally accessed by buyers from across the globe. The first edition of VH&H Expo 2020 will comprise of five-day comprehensive virtual exhibition on sectors like AYUSH & Wellness, Medical Devices, Medical Textiles and Consumables, Pharmaceuticals and Sanitization. The virtual event will also feature webinars and discuss various issues and opportunities in focus sectors, post COVID-19. Dr Reddy said, “ COVID-19 is one of the biggest disaster mankind has ever faced in recent times, bringing disruption to the human life worldwide. With no vaccine or treatment currently in place, containment and social distancing has become the only solution to prevent the spread of hig...

Glenmark Pharmaceuticals on Tuesday said it has initiated Phase 3 clinical trials on antiviral drug Favipiravir to check its efficacy on COVID-19 patients in India. The Mumbai-based company had received approval from Drug Controller General of India (DCGI) last month to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients. Glenmark Pharmaceuticals is the first company in the country to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India, it said in a statement. Clinical trials have commenced and over ten leading government and private hospitals are being enrolled for the study, it added. Glenmark estimates study completion by July/August 2020, it said. As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 symptoms will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment dura...

Global pandemics like Covid-19 require a coordinated global response. And yet what the world is witnessing is quite the opposite. The pandemic has provided new fuel to the US-China squabble, with the two sides engaged in endless mutual recrimination. President Donald Trump’s reported attempt to secure exclusive rights to German biopharma major CureVac’s vaccine reflects a continuing preoccupation with his ‘America First’ approach. China’s authoritarian model and lack of transparency in handling the crisis have dented its global leadership credentials. The G7 meeting last month failed to agree on a statement on the pandemic, accentuating the group’s continuing slide into irrelevance. The G20 Leaders Summit on March 26 called for “a transparent, robust, coordinated, large scale and science based global response in the spirit of solidarity”. However, the ground reality is that more than 75 countries have imposed trade restrictions on Covid-19 related supplies since the beginning of ...

On the first Monday in March, Michel Vounatsos, chief executive of the drug company Biogen, appeared in good spirits. The company's new Alzheimer's drug was showing promise after years of setbacks. Revenues had never been higher. Onstage at an elite health care conference in Boston, Vounatsos touted the drug's "remarkable journey." Asked if the coronavirus that was ravaging China would disrupt supply chains and upend the company's big plans, Vounatsos said no. " So far, so good ," he said.    But even as he spoke, the virus was already silently spreading among Biogen's senior executives, who did not know they had been infected days earlier at the company's annual leadership meeting. Biogen employees, most feeling healthy, boarded planes full of passengers. They drove home to their families. And they carried the virus to at least six states, the District of Columbia and three countries, outstripping the ability of local publi...

The Modi government is working on a contingency plan for the higher education sector as the academic calendar has been disrupted because of the ongoing Covid-19 pandemic.   The plan, which is likely to be announced after 14 April, will include an alternate academic calendar, ways to conduct exams for colleges and universities, a new schedule for vacations and announcement of results.   Apart from this, the plan will also include suggestions to improve the career prospects of students.   The University Grants Commission (UGC) had on 6 April constituted a seven-member committee to look into a contingency plan.   The committee is headed by the vice-chancellor of the Central University of Haryana, R.C. Kuhad. Other members include the vice-chancellors of Banasthali Vidyapith, Panjab University and the Shri Vaishnav Vidyapeeth Vishwavidyalaya, the director of Inter University Accelerator Centre and two joint secretaries of the UGC....

Novalead Pharma recently said it has found that 42 existing drugs can be helpful in treating patients at different stages of coronavirus infection. The conclusions of the startup, which is backed by Tata Capital Healthcare Fund, are based on a study of 2,100 approved drugs and 30 potential viral and human targets. “The major advantage with this approach is that the drugs being approved are already proved to be safe for humans, are being actively manufactured and therefore can be immediately put to use in a very short time,” the company’s chief executive Supreet Deshpande said in a statement. The Pune-based company, which is into the field of drug repurposing, deployed its computational technology for identifying existing drugs which may be potentially effective against the SARS-Cov2 virus (coronavirus) as well as for minimising the impact on the human body, as per the statement. Till now, there is no drug or vaccine that has been developed against the coronavirus infe...

Highlights •Ivermectin is an inhibitor of the COVID-19 causative virus (SARS-CoV-2) in vitro. •A single treatment able to effect ∼5000-fold reduction in virus at 48h in cell culture. •Ivermectin is FDA-approved for parasitic infections, and therefore has a potential for repurposing. •Ivermectin is widely available, due to its inclusion on the WHO model list of essential medicines. Although several clinical trials are now underway to test possible therapies, the worldwide response to the COVID-19 outbreak has been largely limited to monitoring/containment. We report here that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARS-CoV-2 able to effect ∼5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrants further investigation for possible benefits in humans. Ive...

In order to enable registered medical practitioners provide healthcare using telemedicine effectively, Union health ministry has issued telemedicine practice guidelines. These guidelines have been prepared in consultation with NITI Aayog. In India, till now there was no legislation or guidelines on the practice of telemedicine, through video, phone and internet based platforms like web, chat, apps, etc. The purpose of these guidelines is to give practical advice to doctors so that all services and models of care used by doctors and health workers are encouraged to consider the use of telemedicine as a part of normal practice. These guidelines will assist the medical practitioner in pursuing a sound course of action to provide effective and safe medical care founded on current information, available resources, and patient needs to ensure patient and provider safety. These telemedicine guidelines will help realize the full potential of these advancements in technology for h...

Commerce and industry minister Piyush Goyal on Friday told Rajya Sabha that the disruption in business activities in China may have an impact on Indian industries such as pharmaceuticals, automobile and electronics industries, which depend on China for supplies of raw materials, components or intermediate items. He said the outbreak of coronavirus and cancellation of two prestigious diamond exhibitions in Hong Kong are few of the key reasons for decline of exports of polished In a separate reply, he said the impact of those disruptions would vary across companies depending upon their ability to find alternate sources at competitive rates. This in turn would determine their pricing strategy. As per the information available, the National Pharmaceutical Pricing Authority (NPPA) has not received any reference regarding sudden increase in the price of Paracetamol by 40% and Azithromycin by 70% in the country. US trade To a question on whether the government has been conside...

The European Medicines Agency (EMA) provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat the disease) or vaccines (to prevent the disease) against the novel coronavirus disease (COVID-19). Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing 2019-ncov@ema.europa.eu. In a first round of discussions, EMA can provide preliminary informal comments and feedback on the development. This will then allow the Agency to identify the products which are mature enough to benefit from fast-track scientific advice, to guarantee best use of this tool. In the context of the COVID-19 pandemic, with this fast-track scientific advice, the Agency can give developers prompt guidance and direction on the best methods and study designs to generate robust information on how well a medicine or vaccine works and...

Pune-based Serum Institute of India (SII), world's largest vaccine manufacturer by volume, claims to have achieved a breakthrough in developing a vaccine for the dreaded coronavirus contagion. It says the virus-vaccine strain developed in laboratories has reached the animal clinical trial stage, with possible results within two months. Serum Institute had partnered with the US-based biotech drug research company Codagenix three weeks ago to jointly develop a live-attenuated vaccine (creating a vaccine by reducing the virulence of the pathogen, but still keeping it alive) to fight the coronavirus. The company claims it is the first vaccine to progress from the laboratory to the pre-clinical trial phase and can be market ready by 2022. " Serum Institute and Codagenix have been working with utmost diligence and meticulous effort to develop a preventive vaccine against the novel coronavirus. The vaccine-virus strain is identical to the original virus and can generate a r...