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Hyderabad, Amid the gloom caused by COVID-19, one sector which provided a ray of hope was life sciences and turning the challenge into an opportunity, Hyderabad fortified its position as a global force in the world of pharmaceuticals. This southern city, already recognised as a global information technology destination, proved its prowess in the field of pharmaceuticals and biotechnology and emerged as the vaccine capital of the world. Already known as the bulk drug capital of India, Hyderabad witnessed manufacturing of lifesaving COVID-19 drugs like Remdesivir, Hydroxychloroquine and Favipiravir by some of the top pharma companies based here. This was followed by hectic efforts in the city to develop COVID-19 vaccine. In fact, Hyderabad has emerged as the nerve centre of all research and development activities in the country for COVID-19 vaccines and has even attracted international attention. Today, almost all the vaccines being developed in the country for the pandemic have a Hyderabad connect. Four of the six companies developing COVID vaccines in India are based in Hyderabad. <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> is currently conducting Phase III clinical trials of India's first indigenous COVID-19 vaccine Covaxin. Covaxin is being developed in collaboration with <keyword id="1256547" type="COMPANY" weightage="20" keywordseo="The-Indian-Council-of-Medical-Research">the Indian Council of Medical Research</keyword> (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility at Genome Valley here. According to Bharat Biotech, Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results. The Phase III human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. "Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech. In April, Bharat Biotech announced development of CoroFlu, an intranasal vaccine for <keyword id="8698690" type="COMPANY" weightage="20" keywordseo="coronavirus-">Coronavirus.</keyword> University of Wisconsin–Madison and vaccine company FluGen along with Bharat Biotech began the development and testing of CoroFlu. The Hyderabad based company will produce almost 300 million doses of vaccine for global distribution. In May, Bharat Biotech and Thomas Jefferson University of Philadelphia signed an exclusive deal to develop a new vaccine candidate for COVID-19 invented at Jefferson. The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. Bharat Biotech claimed to have excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. The company has so far developed vaccines for H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world's first conjugated vaccine for Typhoid. It has delivered more than four billion doses of vaccines worldwide. It is also the largest Rabies vaccine manufacturer in the world. Another city-based firm Biological E last month initiated clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DCGI). BE is making the vaccine in collaboration with <keyword id="5289395" type="COMPANY" weightage="20" keywordseo="dynavax-technologies-corporation">Dynavax Technologies Corporation</keyword> (Dynavax), a US-based vaccine focused biopharmaceutical company, and <keyword id="503459" type="COMPANY" weightage="20" keywordseo="Baylor-College-of-Medicine">Baylor College of Medicine</keyword>, a health sciences university in Houston. Biological E has also signed an agreement with Johnson &amp; Johnson to produce the latter's vaccine at its vaccine production facilities and sell them both in India and export across various global markets. Indian Immunologicals, a human and animal vaccines maker, too is developing a vaccine for COVID. Hyderabad-based pahrma major Dr Reddy's Laboratories is conducting clinical trials of Russian COVID-19 vaccine, Sputnik V. Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, has collaborated with Dr Reddy's to conduct clinical trials and distribute the vaccine in India. Hyderabad was under spotlight with the recent visits by Prime Minister Narendra Modi and ambassadors of more than 60 countries to the facilities of Bharat Biotech and Biological E in Genome Valley Telangana's industry minister K. T. Rama Rao believes that Hyderabad has cemented its position as the vaccine capital of the world. He pointed out that Hyderabad is already manufacturing more than two billion doses of vaccines every year, which is one-third of the global vaccine output. The city, with its strong ecosystem, has played a critical role in making India not only self-sufficient in the medicine manufacture but also turned it into the pharmacy capital of the world. It accounts for 40 per cent of the total Indian bulk drugs and 50 per cent of the bulk drug exports. Industry leaders believe that Hyderabad will be an integral part of the global efforts to vaccinate the world against COVID. Even if no vaccine is developed in the city, the city will still have a big role to play in global vaccination efforts with the sheer vaccine manufacturing capacity it houses. Hyderabad has the largest US FDA approved vaccine facilities. They have the capacity to manufacture millions of doses with world-class standards. "India's vaccine sector will play a critical role in developing and producing vaccine at scale for distribution across the world. Hyderabad's importance in the global vaccine landscape is only growing," K.T. Rama Rao said. Telangana government has assured the companies that it will play the enabling role in global vaccination efforts against COVID-19. The Hyderabad airport announced few days ago that has developed necessary infrastructure to handle the exports. As per the industry insights, most of India's vaccine export will be to Africa, Latin America and Asian destinations. Hyderabad is already home to more than 800 life sciences companies and the sector employs over 1,20,000 pharmaceutical professionals. It is said to be the only city in the country to house more than 20 incubation centres focused only on life sciences and health-tech. More than 200 start-ups are also working on innovative solutions in healthcare. Genome Valley is India's first organised cluster for life sciences R&amp;D activities spread across 600 square kilometers. Set up in 1999, it has world-class infrastructure facilities in the form of <keyword id="10464926" type="COMPANY" weightage="20" keywordseo="industrial-/-knowledge">Industrial / Knowledge</keyword> parks, Special Economic Zones (SEZs), Multi-tenanted dry and wet laboratories and incubation facilities. It is home to more than 200 companies including presence of the marquee global names like Novartis, GlaxoSmithKline, Ferring Pharma, Chemo, DuPont, Ashland, United States Pharmacopeia and Lonza. With <keyword id="4920024" type="LOCATION" weightage="20" keywordseo="Hyderabad-Pharma-City">Hyderabad Pharma City</keyword> also likely to be operational soon, the city is looking to ramp-up production of Active Pharmaceutical Ingredients (APIs) and thus develop a cluster to help the country compete with China. The new project is expected to create 1,70,000 direct jobs and 5,60,000 indirect jobs. SEE ALSO: <a href="https://www.businessinsider.in/tech/enterprise/news/wistron-apple-iphone-manufacturer-could-face-these-penalties-if-found-guilty/articleshow/79790319.cms">If investigators find Wistron management guilty, here's what is at stake for the company</a> <a href="https://www.businessinsider.in/stock-market/news/heres-what-analysts-say-if-you-should-subscribe-or-not-to-the-300-crore-ipo-of-antony-waste-handling-cell/articleshow/79790998.cms">Antony Waste Handling Cell ₹300-crore IPO will open on Monday— these are the risks and opportunities</a> <a href="https://www.businessinsider.in/business/news/ikea-india-cfo-says-she-still-has-3500-crore-to-be-spent-in-india-the-pandemic-has-changed-targets-but-not-the-investment-plan/articleshow/79790938.cms">INTERVIEW: Ikea CFO says she still has ₹3,500 crore to be spent in India⁠— the pandemic has changed targets but not the investment plan</a>

Hyderabad : Vaccine capital of the world

Hyderabad, Nov 16 (IANS) Biological E. Ltd (BE), a Hyderabad-based vaccines and pharmaceutical company, on Monday announced that it has initiated clinical trial of its Covid-19 subunit vaccine candidate in the country following approval from the Drugs Controller General of India (DGCI). BE is making the vaccine in collaboration with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston. The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialisation team, along with Dynavax's advanced adjuvant CpG 1018, BE said in a statement. BE's Phase 1/2 clinical trials will evaluate the safety and immunogenicity of the vaccine candidate consisting of the receptor binding domain of the spike protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years, it said. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart. The results of this clinical trial are expected to be available by February 2021. "The transition of our vaccine candidate into human trials is an important milestone, and exemplifies a successful transfer of technology with BE, that could lead to a safe, effective and affordable vaccine," said Dr Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children's Hospital Center for Vaccine Development. "This vaccine represents an urgent biotechnology innovation for ensuring health equity and combating the Covid-19 pandemic," said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children's Hospital Center for Vaccine Development. "We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of Covid-19," said Mahima Datla, Managing Director, Biological E. Ltd. "We are proud to contribute CpG 1018 to support development of an adjuvanted vaccine to prevent Covid-19. CpG 1018's potential to boost the immune response to produce more antibodies and longer lasting immunity may also minimise the dose of antigen needed, enabling vaccination of a greater number of people," said Ryan Spencer, Chief Executive Officer of Dynavax. --IANS ms/vd

Biological E begins clinical trials of Covid-19 vaccine

Hyderabad, Dec 9 (IANS) Envoys of 64 countries on Wednesday visited the facilities of Bharat Biotech and Biological E, which are developing vaccines for coronavirus. After landing in Hyderabad by a special Air India flight, the Ambassadors and High Commissioners from the countries in Asia, Africa, Europe, North America, South America, and Oceania reached Genome Valley on the city outskirts to visit the two companies. The visit by the heads of foreign missions was organised by the Ministry of External Affairs (MEA) and was part of India's efforts to develop partnerships for the manufacture and delivery of vaccines. Last month, the diplomats were briefed on trials of vaccines underway in the country and efforts to manufacture and deliver the doses. Officials said the diplomats were divided into two batches and they went around the two companies to see for themselves the facilities developed for research and manufacturing of vaccines. Top officials of both the companies briefed the envoys about the progress made so far in the development of the vaccines and the rollout plans by both the companies after their vaccines get the approval from regulators. At Bharat Biotech, the delegation was briefed about company's vaccine development programme by Dr. Krishna Ella, Chairman and Managing Director, spearheading Covaxin research, development, clinical trials and production teams. The delegates were explained about Bharat Biotech's research process, manufacturing capabilities, expertise through virtual and physical tours of the facilities. The envoys voiced their appreciation of the company's work of national and global public health significance. Covaxin, India's indigenous Covid-19 vaccine, is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility. Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses. According to Bharat Biotech, Covaxin has been evaluated in approximately 1000 subjects in Phase 1 and Phase 2 clinical trials, with promising safety and immunogenicity results. The Phase 3 human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India's first and only Phase 3 efficacy study for a Covid-19 vaccine, and the largest phase 3 efficacy trial ever conducted for any vaccine in India. "The development and clinical evaluation of COVAXIN marks a significant milestone for novel vaccinology in India. Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech while addressing the foreign envoys. Biological E last month initiated clinical trial of its Covid-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI). It is making the vaccine in collaboration with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston. Telangana Chief Secretary Somesh Kumar also addressed the diplomats and showcased the potential of the state. He said though being the youngest state in the country, Teangana achieved tremendous progress under the dynamic leadership of Chief Minister K. Chandrasekhar Rao. He also informed that the combined value of the pharma sector in the state is around $50 billion. Hyderabad is the vaccine hub of not only India but the entire world with 33 percent of the entire vaccine production being done in Hyderabad. During the last six years, the state has been a front ranker in the ease of doing business in the country. The state is home to some of the top valued companies such as Google, Apple, Facebook, Amazon, Microsoft etc. Most of these companies have their largest establishments outside the US in Hyderabad. The Chief Secretary told the diplomats that the state has formulated a new TSiPASS policy for speedy approvals to the industries. Industries who do not get permission within 15 days are deemed to have been approved. This policy has proved to be a game changer and during the last six years around 14,000 units have been grounded in the state. Principal Secretary Industries and IT, Jayesh Ranjan, also made a power point presentation and showcased the investment potential of the state to the visiting dignitaries. He said that Hyderabad Pharma city will be operational in a couple of months. Similarly a medical devices park is being set up near Outer Ring Road in 500 acres. --IANS ms/vd

Envoys of 64 countries visit Covid vaccine makers in Hyderabad

Hyderabad, Dec 20 (IANS) Amid the gloom caused by COVID-19, one sector which provided a ray of hope was life sciences and turning the challenge into an opportunity, Hyderabad fortified its position as a global force in the world of pharmaceuticals. This southern city, already recognised as a global information technology destination, proved its prowess in the field of pharmaceuticals and biotechnology and emerged as the vaccine capital of the world. Already known as the bulk drug capital of India, Hyderabad witnessed manufacturing of lifesaving COVID-19 drugs like Remdesivir, Hydroxychloroquine and Favipiravir by some of the top pharma companies based here. This was followed by hectic efforts in the city to develop COVID-19 vaccine. In fact, Hyderabad has emerged as the nerve centre of all research and development activities in the country for COVID-19 vaccines and has even attracted international attention. Today, almost all the vaccines being developed in the country for the pandemic have a Hyderabad connect. Four of the six companies developing COVID vaccines in India are based in Hyderabad. Bharat Biotech is currently conducting Phase III clinical trials of India's first indigenous COVID-19 vaccine Covaxin. Covaxin is being developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility at Genome Valley here. According to Bharat Biotech, Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results. The Phase III human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. "Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech. In April, Bharat Biotech announced development of CoroFlu, an intranasal vaccine for Coronavirus. University of WisconsinMadison and vaccine company FluGen along with Bharat Biotech began the development and testing of CoroFlu. The Hyderabad based company will produce almost 300 million doses of vaccine for global distribution. In May, Bharat Biotech and Thomas Jefferson University of Philadelphia signed an exclusive deal to develop a new vaccine candidate for COVID-19 invented at Jefferson. The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. Bharat Biotech claimed to have excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. The company has so far developed vaccines for H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world's first conjugated vaccine for Typhoid. It has delivered more than four billion doses of vaccines worldwide. It is also the largest Rabies vaccine manufacturer in the world. Another city-based firm Biological E last month initiated clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DCGI). BE is making the vaccine in collaboration with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston. Biological E has also signed an agreement with Johnson &amp; Johnson to produce the latter's vaccine at its vaccine production facilities and sell them both in India and export across various global markets. Indian Immunologicals, a human and animal vaccines maker, too is developing a vaccine for COVID. Hyderabad-based pahrma major Dr Reddy's Laboratories is conducting clinical trials of Russian COVID-19 vaccine, Sputnik V. Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, has collaborated with Dr Reddy's to conduct clinical trials and distribute the vaccine in India. Hyderabad was under spotlight with the recent visits by Prime Minister Narendra Modi and ambassadors of more than 60 countries to the facilities of Bharat Biotech and Biological E in Genome Valley Telangana's industry minister K. T. Rama Rao believes that Hyderabad has cemented its position as the vaccine capital of the world. He pointed out that Hyderabad is already manufacturing more than two billion doses of vaccines every year, which is one-third of the global vaccine output. The city, with its strong ecosystem, has played a critical role in making India not only self-sufficient in the medicine manufacture but also turned it into the pharmacy capital of the world. It accounts for 40 per cent of the total Indian bulk drugs and 50 per cent of the bulk drug exports. Industry leaders believe that Hyderabad will be an integral part of the global efforts to vaccinate the world against COVID. Even if no vaccine is developed in the city, the city will still have a big role to play in global vaccination efforts with the sheer vaccine manufacturing capacity it houses. Hyderabad has the largest US FDA approved vaccine facilities. They have the capacity to manufacture millions of doses with world-class standards. "India's vaccine sector will play a critical role in developing and producing vaccine at scale for distribution across the world. Hyderabad's importance in the global vaccine landscape is only growing," K.T. Rama Rao said. Telangana government has assured the companies that it will play the enabling role in global vaccination efforts against COVID-19. The Hyderabad airport announced few days ago that has developed necessary infrastructure to handle the exports. As per the industry insights, most of India's vaccine export will be to Africa, Latin America and Asian destinations. Hyderabad is already home to more than 800 life sciences companies and the sector employs over 1,20,000 pharmaceutical professionals. It is said to be the only city in the country to house more than 20 incubation centres focused only on life sciences and health-tech. More than 200 start-ups are also working on innovative solutions in healthcare. Genome Valley is India's first organised cluster for life sciences R&amp;D activities spread across 600 square kilometers. Set up in 1999, it has world-class infrastructure facilities in the form of Industrial / Knowledge parks, Special Economic Zones (SEZs), Multi-tenanted dry and wet laboratories and incubation facilities. It is home to more than 200 companies including presence of the marquee global names like Novartis, GlaxoSmithKline, Ferring Pharma, Chemo, DuPont, Ashland, United States Pharmacopeia and Lonza. With Hyderabad Pharma City also likely to be operational soon, the city is looking to ramp-up production of Active Pharmaceutical Ingredients (APIs) and thus develop a cluster to help the country compete with China. The new project is expected to create 1,70,000 direct jobs and 5,60,000 indirect jobs. --IANS ms/kr

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Hyderabad : Vaccine capital of the world

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Biological E begins clinical trials of Covid-19 vaccine

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Envoys of 64 countries visit Covid vaccine makers in Hyderabad

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Hyderabad: Vaccine capital of the world

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