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<ul><li>In the phase of trials, the company will be enrolling over 1,000 subjects across multiple clinical study sites in India, it said in a regulatory filing. </li><li>The adaptive phase I/ II <keyword id="977427" type="PERSON" weightage="20" keywordseo="human-clinical-trials">human clinical trials</keyword> of ZyCoV-D have commenced with the first human dosing, it said, adding that "the adaptive phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine." </li><li>Earlier this month, Zydus had received approval from domestic authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> infections worldwide. </li></ul><keyword id="9577763" type="UNKNOWN" weightage="20" keywordseo="drug-firm-zydus-cadila">Drug firm Zydus Cadila</keyword> on Wednesday said it has started human clinical trials of its COVID-19 vaccine candidate ZyCoV-D. In the phase of trials, the company will be enrolling over 1,000 subjects across multiple clinical study sites in India, it said in a regulatory filing. The adaptive phase I/ II human clinical trials of ZyCoV-D have commenced with the first human dosing, it said, adding that "the adaptive phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine." Earlier this month, Zydus had received approval from domestic authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide. It got approval a few days after India's first indigenous COVID-19 vaccine candidate COVAXIN, developed by city-based <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> in collaboration with <keyword id="6364555" type="COMPANY" weightage="20" keywordseo="Indian-Council-of-Medical-Research">Indian Council of Medical Research</keyword> and National Institute of Virology, got the nod for human clinical trials from the Drug Controller General of India Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 356.50 apiece on BSE, up 0.81 per cent against their previous close. SEE ALSO: <a href="https://www.businessinsider.in/india/news/photographer-of-the-viral-black-panther-images-from-india-shares-his-story/articleshow/76830618.cms">INTERVIEW: Shaaz Jung opens up about the blood, sweat and years behind the viral images of a rare black panther</a> <a href="https://www.businessinsider.in/tech/news/intel-will-speed-up-mukesh-ambanis-5g-run-power-him-with-ai-and-possibly-a-jio-laptop/articleshow/76780290.cms">Intel will speed up Mukesh Ambani’s 5G run, power him with AI and possibly a Jio laptop⁠— all in return for massive amount of data</a>

Zydus Cadila begins human clinical trials of COVID-19 vaccine candidate

By Gurdip Singh Singapore, Jun 10 () A Singapore-based biotechnology firm will begin human clinical trials next week for a potential monoclonal antibody treatment for COVID-19 that could slow down the progression of the disease in patients, help them recover faster, and provide temporary protection against it. Tychan, a firm backed by state investor Temasek Holdings, said in a statement on Wednesday has received approval from Singapore's Health Sciences Authority (HSA) for the Phase 1 clinical safety trial in healthy volunteers. The firm has developed TY027, a monoclonal antibody that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. Antibodies are generated in the body to fight off infection. Monoclonal antibodies mimic natural antibodies and can be isolated and manufactured in large quantities to treat diseases in patients. Presently, there is no proven antibody-based treatment for COVID-19. There is also no licensed vaccine to prevent SARS-CoV-2 infection, Tychan said. Tychan may become the first firm to start its human clinical trial in Singapore, although efforts in developing an antibody-based treatment are underway here and globally. As of Tuesday, Tychan's was the only registered clinical trial internationally for such a treatment, according to a report by Channel News Asia. Depending on the results of the trial, there are various ways it can be used, said Professor Ooi Eng Eong of Duke-National University of Singapore (Duke-NUS) Medical School, who is also the firm's co-founder. "You could use it to treat all COVID-19 patients and prevent them from getting severe disease. You could also give it to those who are going to get severe disease and prevent them then from sliding further in their respiratory function," the Channel quoted Professor Ooi as saying. For those who already require oxygen, the hope is that the drug will prevent them from needing a ventilator, and for patients who are already on ventilators, that they could go off the ventilators, he explained. "If the treatment works for COVID-19, then we could change a lot. We could reduce a lot of problems that we face," he said, noting that patients with severe disease need oxygen and ventilators, without which they would die. "We hope that this treatment that we have will reduce the number of people who go into such severe disease and hopefully, the number of people who die of COVID-19 becomes minimal," said Ooi. The drug will also be evaluated for its potential to provide temporary protection against infection with SARS-CoV-2, Tychan said. "We could even, for instance, give this to healthcare workers who are treating COVID-19 patients so that they don't get infections themselves," Prof Ooi said, adding that this would depend on the results of the trial. People travelling to places with many COVID-19 cases could also use the drug to prevent infection, he said. Doses of the monoclonal antibody will be administered by blood to 23 healthy volunteers, and the research team will then evaluate its safety. The Phase 1 trial, to be conducted by SingHealth Investigational Medicine Unit, will take about six weeks to evaluate the safety and tolerability of TY027, Tychan said. The potential treatment was developed in partnership with the Ministry of Defence, Ministry of Health, the Economic Development Board and other Government agencies as part of a whole-of-government effort, according to the Channel report. GS NSA

Singapore biotech firm to begin human clinical trial for COVID-19 treatment

Hyderabad, June 29 () The country's 'first' indigenous COVID-19 vaccine COVAXIN, developed by city-based Bharat Biotech in collaboration with ICMR and NIV, has got the nod for human clinical trials from the Drug Controller General of India, the company said on Monday. The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2, approved after pre-clinical studies demonstrated safety and immune response, would start across the country next month. The collaboration with Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) was instrumental in the development of the vaccine, the company said in a release. The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley here, a release said. The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health &amp; Family Welfare granted permission to initiate Phase I &amp; II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020, the release said. Chairman and Managing Director of the company Dr. Krishna Ella said: We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. "The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&amp;D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," he said. Expedited through the national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses, the released added. Besides Bharat Biotech, at least five other Indian companies are working on a vaccine for the deadly coronavirus while similar efforts are underway in different countries. GDK VS VS

India's first COVID-19 vaccine by Bharat Biotech gets DCGI nod for human clinical trials

By K J M Varma Beijing, Apr 13 () Chinese scientists have started the second phase of a clinical trial of a vaccine for coronavirus at the country's epicentre Wuhan as the global race to develop a drug to curb the pandemic intensified.The vaccine, developed by the Institute of Biotechnology, Academy of Military Medical Sciences of China for the novel coronavirus has entered Phase II of a human clinical trial on Sunday with 500 volunteer participants, state-run China Daily reported on Monday.The eldest volunteer is 84-year-old Wuhan resident Xiong Zhengxing, who completed the vaccination on Monday morning, accompanied by his daughter.The vaccine is developed by genetic engineering methods and is used to prevent diseases caused by novel coronavirus infections, the report said.The first phase of the vaccine clinical trial focused on its safety, while the second phase weighs more on its efficacy. Unlike the first phase, the second phase recruited more participants and introduced a placebo control group.Volunteer recruitment for the vaccine began on Thursday. It is China's first candidate for the virus that entered clinical human testing. The Phase I trial was conducted in March.Following the outbreak of Covid-19, many other Chinese institutes are also stepping up efforts to develop vaccines for the disease.China has stepped up the process to finalise vaccines to counter Covid-19 after Kaiser Permanente research facility in Seattle and Washington stole the march and began human trials.There is a global race to develop the vaccine. India's Serum Institute of India and Bharat Biotech lab too are developing the vaccine besides Australia and the UK.Currently, there are no effective drugs for the deadly disease, although several candidate drugs are in clinical trials.Scientists say China may have a head start on the development of the vaccine as it was the first to map out the genome sequence of the novel coronavirus as the virus surfaced in Wuhan in December last year. China subsequently shared the sequence with the WHO, the US and other countries, setting off the race to develop the vaccine. KJV NSA

China begins phase-II clinical trial of Covid-19 vaccine in Wuhan

By K J M Varma Beijing, Apr 14 () A Chinese research firm attached to the military has become the first organisation to enter the second clinical-trial stage in the global race to develop a vaccine for the coronavirus infection, which has claimed nearly 120,000 lives across the world so far.China has approved three COVID-19 vaccine submissions for clinical trials, state-run Xinhua news agency quoted a Ministry of Science and Technology official as saying on Tuesday.An adenovirus vector vaccine, developed by a research team led by Major General Chen Wei of the Institute of Military Medicine under the Academy of Military Sciences of the People's Liberation Army, was the first to be approved to enter clinical trial.The first phase of the clinical trial was completed at the end of March, and the second phase started on April 12.It is the first COVID-19 vaccine in the world that has entered the second phase of clinical trial, the Xinhua report quoting the World Health Organization as saying.On Sunday, the vaccine developed by the Institute of Biotechnology, Academy of Military Medical Sciences of China, entered Phase II of a human clinical trial with 500 volunteer participants.The eldest volunteer is a 84-year-old Wuhan resident, Xiong Zhengxing, who completed the vaccination on Monday morning.The vaccine is developed by genetic engineering methods and is used to prevent diseases caused by novel coronavirus infections, state-run China Daily reported on Monday.The first phase of the vaccine clinical trial focused on its safety, while the second phase weighs more on its efficacy. Unlike the first phase, the second phase recruited more participants and introduced a placebo control group.Volunteer recruitment for the vaccine began on Thursday. It is China's first candidate for the virus that entered clinical human testing. The Phase I trial was conducted in March.Following the outbreak of COVID-19 in the central Chinese city of Wuhan, many other Chinese institutes are also stepping up efforts to develop vaccines for the deadly disease that has killed over 120,000 people and infected 1,929,000 across the globe.China has stepped up the process to finalise vaccines to counter COVID-19 after Kaiser Permanente research facility in Seattle and Washington stole the march and began human trials. On Monday, the WHO said a safe and effective vaccine would be needed to fully halt the spread of COVID-19."Our global connectedness means the risk of re-introduction and resurgence of COVID-19 will continue," WHO Director-General Tedros Adhanom Ghebreyesus told a virtual briefing from Geneva, stressing that "ultimately, the development and delivery of a safe and effective vaccine will be needed to fully interrupt transmission." There is a global race to develop the vaccine. India's Serum Institute of India and Bharat Biotech lab are also developing vaccines besides firms in Australia and the UK.Currently, there are no effective drugs for the deadly disease, although several candidate drugs are in clinical trials.Scientists say China may have a head start on the development of the vaccine as it was the first to map out the genome sequence of the novel coronavirus after it surfaced in Wuhan city in December last year.China subsequently shared the genome sequence with the WHO, the US and other countries, setting off the race to develop the vaccine. KJV IND AKJ

Chinese research firm attached to PLA first to start 2nd clinical trial for coronavirus vaccine

<ul class="summary-list"><li><keyword id="11897862" type="UNKNOWN" weightage="100" keywordseo="elon-musk" source="Orion">Elon Musk</keyword> said in December <keyword id="12199118" type="UNKNOWN" weightage="60" keywordseo="neuralink" source="Orion">Neuralink</keyword> hopes to start implanting its brain <keyword id="12002671" type="UNKNOWN" weightage="60" keywordseo="chips" source="Orion">chips</keyword> in humans this year.</li><li>The company's hiring of a clinical director is a sign that it's moving toward human trials.</li></ul>Elon Musk's Neuralink is hiring a clinical trial director — a sign that the brain-interface technology is moving toward implanting chips in humans.According to the <a href="https://boards.greenhouse.io/neuralink/jobs/4723041003">job ad,</a> the clinical director will be working with the startup's "first Clinical Trial participants!"Job requirements include understanding the clinical trial process from beginning to end and managing communication with the Food and Drug Administration (<keyword id="11899468" type="UNKNOWN" weightage="60" keywordseo="fda" source="Orion">FDA</keyword>.)The ad for the Fremont, California-based job also says the position offers "an opportunity to change the world and work with some of the smartest and the most talented experts from different fields."Medical device makers generally employ clinical directors just as they start interacting with the FDA so that they can design trials that have better chances of approval, according to <a href="https://www.bloomberg.com/news/articles/2022-01-20/elon-musk-s-brain-implant-company-is-inching-toward-human-trials">Bloomberg,</a> which first reported the news.Neuralink co-founder and CEO <a href="https://www.businessinsider.com/elon-musk-neuralink-hopes-to-start-human-testing-2022-2021-12">Musk</a> said at The Wall Street Journal's <a href="https://youtu.be/lSD_vpfikbE?t=1362">CEO Council Summit</a> last month that the startup hopes to begin implanting microchips in humans this year, pending FDA approval. <a href="https://twitter.com/elonmusk/status/1380315654524301315">Musk</a> tweeted in April last year the "first @Neuralink product will enable someone with paralysis to use a smartphone with their mind faster than someone using thumbs."He said at the WSJ summit that the company's "standards for implanting the device are substantially higher than what the FDA requires.""Progress will accelerate when we have devices in humans (hard to have nuanced conversations with monkeys) next year," he <a href="https://twitter.com/elonmusk/status/1468070398369701890">tweeted</a> on December 7.Neuralink did not immediately respond to Insider's request for comment.Last April, <a href="https://www.businessinsider.com/elon-musk-neuralink-video-monkey-games-pong-brain-chip-2021-4">Neuralink</a> released a video of a <keyword id="11969418" type="UNKNOWN" weightage="60" keywordseo="monkey" source="Orion">monkey</keyword> playing a video game using chips implanted in its brain. Musk said in February last year that Neuralink could start implanting chips in humans by the end of 2021. The year before, the company said it hoped to start trials by end-2020, according to <a href="https://www.theverge.com/2019/7/16/20697123/elon-musk-neuralink-brain-reading-thread-robot">The Verge,</a> citing a presentation by Musk.

Elon Musk's Neuralink is hiring a clinical trial director as it moves towards testing chip implants in humans

(Eds: Adds details about COVID vaccine) New Delhi, Jul 3 () Zydus on Friday said it has received approval from authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide. The vaccine, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement. This comes within days of Bharat Biotech's Covaxin vaccine getting approval of the drug regulator to start clinical trials. Over seven vaccines are being researched in India and two of them have got go-ahead to start human clinical trials just this week. Globally, over 100 candidates are being tested on humans but no vaccine has yet been approved. "Zydus has already manufactured clinical good manufacturing practice (GMP) batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects," the company said. ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the Drug Controller General of India (DGCI) - Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cadila Healthcare said. In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate, it said. It further said no safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic. Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe. The company claimed that the vaccine candidate has no vector response and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements. It is also known to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said. "Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection," it added. The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand. RKL MR

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Zydus Cadila begins human clinical trials of COVID-19 vaccine candidate

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Singapore biotech firm to begin human clinical trial for COVID-19 treatment

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India's first COVID-19 vaccine by Bharat Biotech gets DCGI nod for human clinical trials

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China begins phase-II clinical trial of Covid-19 vaccine in Wuhan

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Chinese research firm attached to PLA first to start 2nd clinical trial for coronavirus vaccine

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Elon Musk's Neuralink is hiring a clinical trial director as it moves towards testing chip implants in humans

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Zydus gets nod for human trials of COVID-19 vaccine

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