COVID 19 Vaccine Development/Regulatory/Distribution Programs Update

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COVID 19 Vaccine Development/Regulatory/Distribution Programs Update

Dr. Reddy’s partners with Department of Biotechnology – Biotechnology Industry Research Assistance Council for Sputnik V vaccine clinical trials in India
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announced its partnership with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), Government of India, for advisory support on clinical trials of Sputnik V vaccine in India.
“We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.”
The partnership will allow Dr. Reddy’s to identify and use some of BIRAC’s clinical trial centres for the vaccine, which are funded under the National Biopharma Mission (NBM), implemented by Project Management Unit-NBM at BIRAC. Further, the Company will have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine.
Satish Reddy, Chairman, Dr. Reddy’s Laboratories said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.”…

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Moderna Partners with Takeda and the Government of Japan to Supply 50 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) to Japan
MHLW and Takeda will import and distribute mRNA-1273 in Japan starting in the first half of 2021
October 28, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., Ltd (NYSE: TAK) have agreed to purchase and distribute 50 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the Japanese public as soon as possible, subject to necessary regulatory approvals. Moderna is responsible for the manufacture and supply of Moderna’s vaccine candidate, and Takeda, with the support of the MHLW, the Japan Agency for Medical Research and Development (AMED) and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan to ensure timely access starting during the first half of 2021…

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UK Medicines and Healthcare products Regulatory Agency Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
Moderna completed enrollment of its Phase 3 COVE study of mRNA-1273 on October 22
Rolling review based on preclinical, CMC, and clinical data available to date
October 27, 2020

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has started the rolling review process of mRNA-1273, the Company’s vaccine candidate against COVID-19. This announcement follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine

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Moderna Announces Supply Agreement with the Ministry of Public Health to Supply Qatar with mRNA Vaccine Against COVID-19 (mRNA-1273)
Supply agreement reflects Moderna’s commitment to make its vaccine available in Qatar
October 26, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support the Ministry’s ongoing efforts to secure early access to a safe and effective COVID-19 vaccine for the people of Qatar…