{"id":415900,"date":"2021-01-15T12:36:56","date_gmt":"2021-01-15T17:36:56","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=415900"},"modified":"2021-01-15T12:36:56","modified_gmt":"2021-01-15T17:36:56","slug":"dr-reddys-receives-approval-to-conduct-phase-3-clinical-trial-for-sputnik-v-vaccine-in-india","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dr-reddys-receives-approval-to-conduct-phase-3-clinical-trial-for-sputnik-v-vaccine-in-india\/","title":{"rendered":"Dr. Reddy\u2019s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Dr. Reddy\u2019s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India<\/b><\/p>\n<p>HYDERABAD, India&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nDr. Reddy\u2019s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India.\n<\/p>\n<p>\nThe phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India.\n<\/p>\n<p>\nEarlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. In its report, the DSMB concluded that no safety concerns were identified and the study met the primary endpoints of safety.\n<\/p>\n<p>\nG V Prasad, Co-chairman and Managing Director, Dr. Reddy\u2019s Laboratories said, \u201cThis is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population.\u201d\n<\/p>\n<p>\nIn September 2020, Dr. Reddy\u2019s partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.\n<\/p>\n<p>\nSputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world\u2019s first registered vaccine against COVID-19 based on the established human adenoviral vector platform. The vaccine\u2019s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia. Currently, the vaccine\u2019s clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.\n<\/p>\n<p><b>About Dr. Reddy\u2019s<\/b>: Dr. Reddy\u2019s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses &#8211; Pharmaceutical Services &amp; Active Ingredients, Global Generics and Proprietary Products \u2013 Dr. Reddy\u2019s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy\u2019s operates in markets across the globe. Our major markets include \u2013 USA, India, Russia &amp; CIS countries, and Europe. For more information, log on to:<b \/><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.drreddys.com&amp;esheet=52362831&amp;newsitemid=20210115005495&amp;lan=en-US&amp;anchor=www.drreddys.com&amp;index=1&amp;md5=94d5eec302eaefaf7b69c26e0e9db5db\">www.drreddys.com<\/a><\/p>\n<p>\nDisclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management\u2019s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words &#8220;may&#8221;, &#8220;will&#8221;, &#8220;should&#8221;, &#8220;expects&#8221;, &#8220;plans&#8221;, &#8220;intends&#8221;, &#8220;anticipates&#8221;, &#8220;believes&#8221;, &#8220;estimates&#8221;, &#8220;predicts&#8221;, &#8220;potential&#8221;, or &#8220;continue&#8221; and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency \/ severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and\/or governments, (v) the impact of acquisitions or reorganization, including related integration issues <b>, <\/b>and (vi) the susceptibility of our industry and the markets addressed by our, and our customers\u2019, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the &#8220;Risk Factors&#8221; and &#8220;Forward-Looking Statements&#8221; sections of our Annual Report on Form 20-F for the year ended March 31, 2020. The company assumes no obligation to update any information contained herein.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210115005495r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20210115005495\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210115005495\/en\/<\/a><\/span><\/p>\n<p><b>INVESTOR RELATIONS<br \/>\n<\/b><br \/>AMIT AGARWAL<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:amita@drreddys.com\">amita@drreddys.com<br \/>\n<\/a><br \/>(PH: +91-40-49002135)\n<\/p>\n<p><b>MEDIA RELATIONS<br \/>\n<\/b><br \/>APARNA TEKURI<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:aparnatekuri@drreddys.com\">aparnatekuri@drreddys.com<br \/>\n<\/a><br \/>(PH: +91-40- 49002446)\n<\/p>\n<p><b>KEYWORDS:<\/b> India Asia Pacific<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Infectious Diseases Pharmaceutical Health Clinical Trials<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20210115005495\/en\/485181\/3\/DrR_Logo_Primary_RGB.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Dr. Reddy\u2019s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India HYDERABAD, India&#8211;(BUSINESS WIRE)&#8211; Dr. Reddy\u2019s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India. The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. In its report, the DSMB concluded that no safety concerns &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/dr-reddys-receives-approval-to-conduct-phase-3-clinical-trial-for-sputnik-v-vaccine-in-india\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Dr. Reddy\u2019s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-415900","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dr. Reddy\u2019s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/dr-reddys-receives-approval-to-conduct-phase-3-clinical-trial-for-sputnik-v-vaccine-in-india\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dr. Reddy\u2019s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Dr. Reddy\u2019s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India HYDERABAD, India&#8211;(BUSINESS WIRE)&#8211; Dr. Reddy\u2019s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India. The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. 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The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. 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