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Vaccines & Immunizations

MSD and 4D Pharma Collaborate to Develop Live Biotherapeutics for Vaccines

LEEDS, England, Oct. 8, 2019 /PRNewswire/ — 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces that the Company has entered into a research collaboration and option to license agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to …

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FDA Approves Bavarian Nordic’s Jynneos Vaccine for Prevention of Smallpox and Monkeypox Disease in Adults

COPENHAGEN, Denmark, September 24, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the U.S. Food and Drug Administration (FDA) has approved JYNNEOS™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) (MVA-BN®, liquid-frozen) for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to …

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FDA Grants Priority Review to Merck’s BLA for V920, an Investigational Vaccine for Ebola Zaire Virus

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Merck’s investigational Ebola vaccine (V920), under review for the prevention of disease caused by the Ebola …

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Moderna Announces Positive Phase 1 Results for the First Systemic Messenger RNA Therapeutic Encoding a Secreted Protein

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive data in the first analysis of safety and activity in its Phase 1 study evaluating escalating doses of mRNA-1944 …

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FDA Grants Breakthrough Therapy Designation to Janssen’s Investigational Prophylactic Vaccine for Prevention of Respiratory Syncytial Virus in Older Adults

LEIDEN, Netherlands, Sept. 3, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the Company’s investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in …

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Themis Bioscience Announces Exclusive License and Research Collaboration Agreement with MSD to Develop Vaccine Candidates

VIENNA–(BUSINESS WIRE)–Themis Bioscience announced today a research collaboration and exclusive license agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA) for the discovery and development of undisclosed vaccine candidates using Themis’ measles virus vector-based platform. “Given the versatility of our immune-modulation platform and our proven ability to rapidly …

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FDA Grants Fast Track Designation to Moderna’s Zika Vaccine mRNA-1893

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational Zika vaccine (mRNA-1893) currently …

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Neon Therapeutics’ Neoantigen Vaccine Study Demonstrates Prolonged PFS in Advanced or Metastatic Melanoma, NSCLC and Bladder Cancer

CAMBRIDGE, Mass., July 15, 2019 (GLOBE NEWSWIRE) — Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today announced top-line results, with at least 12-month median follow-up, from the ongoing, multicenter Phase 1b clinical trial evaluating NEO-PV-01, Neon’s personal neoantigen vaccine candidate, in combination with OPDIVO in patients …

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VBI Vaccines Announces Positive Top-Line Results from Phase 3 Study of its Investigational Hepatitis B Vaccine Sci-B-Vac

CAMBRIDGE, Mass., June 17, 2019 (GLOBE NEWSWIRE) — VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced positive top-line results from the randomized, double-blind, pivotal Phase 3 study, PROTECT, designed to evaluate the efficacy and safety of a 10 µg …

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FDA Grants Limited Approval of Sanofi Pasteur’s Dengue Vaccine in Children

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic …

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