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Russian application of Sputnik V vaccine for WHO vaccine prequalification among the first applications submitted

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Business
27 October 2020
Russian Direct Investment Fund (RDIF)The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund), has submitted applications to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of the world's first registered vaccine against the coronavirus Sputnik V, which is based on a well-studied platform of human adenoviral vectors. The Russian Federation has become one of the first countries to apply to WHO for prequalification of its vaccine against the novel coronavirus infection.
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Novavax provides Phase 3 COVID-19 vaccine clinical development update

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Business
27 October 2020
Novavax, Inc.Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced updates on its Phase 3 clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.
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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)

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Business
26 October 2020
Moderna, Inc.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.
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CureVac reports positive preclinical data for its COVID-19 vaccine candidate, CVnCoV

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Business
23 October 2020
CureVacCureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced data from preclinical studies of its investigational SARS-CoV-2 vaccine candidate, CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and very good T cell activation.
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Moderna completes enrollment of Phase 3 COVE study of mRNA vaccine against COVID-19 (mRNA-1273)

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Business
22 October 2020
Moderna, Inc.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 it has completed enrollment of 30,000 participants for the Phase 3 COVE study of mRNA-1273, its vaccine candidate against COVID-19, being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
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Regeneron's REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients

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Business
13 October 2020
Regeneron Pharmaceuticals, Inc.Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits.
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CureVac expected to receive up to 252 million euros from the German Federal Ministry of Research for further COVID-19 vaccine development and production capacity expansion

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Business
10 September 2020
CureVacCureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA) in clinical trials, has received notification from the German Federal Ministry of Education and Research (BMBF) that CureVac is expected receive up to 252 million euros to support the development of its COVID-19 vaccine candidate.
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  7. Top 20 breaking World Pharma News of 2018
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Business & Industry

  • Roche enters partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure
  • Nearly 700,000 US hospitalizations and 110,000 deaths prevented from the Pfizer-BioNTech COVID-19 vaccine
  • Pfizer and BioNTech provide update on COVID-19 vaccine supply agreement with European Commission
  • Roche pledges to extend commitment to the World Federation of Hemophilia Humanitarian Aid Program to 2028
  • Pfizer to acquire Biohaven Pharmaceuticals

Research & Development

  • "Natural immunity" from omicron is weak and limited, study finds
  • mRNA booster vaccines may be a good investment in developing countries
  • Blocking spike captors to counter COVID
  • Recurring brain tumor growth is halted with new drug
  • Investigational COVID mucosal vaccine protects against disease and transmission
  • Using AI to analyze large amounts of biological data
  • Cognitive impairment from severe COVID-19 equivalent to 20 years of ageing, study finds

Conferences & Events

  • Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
  • SMi's 22nd Annual Pain Therapeutics Conference
  • SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
  • SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
  • SMi's 3rd Annual AI in Drug Discovery Conference
  • SMi's 6th Annual Highly Potent Active Pharmaceutical Ingredients
  • SMi's 9th Annual Conference Pre-Filled Syringes East Coast

Regulatory Affairs

  • FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
  • FDA limits use of Janssen COVID-19 vaccine to certain individuals
  • EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • FDA approves first generic of Symbicort to treat asthma and COPD
  • FDA approves treatment for wider range of patients with heart failure
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