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Vaccines & Immunizations

First Global Guidance for HPV Vaccination for Cervical Cancer Prevention

ALEXANDRIA, Va. – The American Society of Clinical Oncology (ASCO) today issued a clinical practice guideline on human papillomavirus (HPV) vaccination for the prevention of cervical cancer. This is the first guideline on primary prevention of cervical cancer that is tailored to multiple regions of the world with different levels …

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FDA Research to Help Speed Development of Zika Virus Vaccines and Therapeutics

A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLoS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies …

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FDA Rejects Dynavax’s Hepatitis B Vaccine

BERKELEY, CA — (Marketwired) — 11/14/16 — Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years …

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GSK Seeks Approval for its Blockbuster Shingles Vaccine

GlaxoSmithKline  plc (LSE/NYSE: GSK) today announced that it has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, ShingrixTM, to the United States Food and Drug Administration (FDA), seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over. The candidate vaccine is a …

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Takeda to Develop Zika Vaccine with up to $312 Million in Funding from US Government

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda’s Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world. Initial funding from BARDA, which is …

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Merck and Moderna Partner to Advance Novel Personalized Cancer Vaccines with Keytruda for Multiple Types of Cancer

KENILWORTH, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Moderna Therapeutics today announced a strategic collaboration and license agreement to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. The collaboration will combine Merck’s established leadership in immuno-oncology with Moderna’s pioneering …

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AXON’s Alzheimer’s Vaccine Starts Mid-Stage Trial

BRATISLAVA, Slovakia–(BUSINESS WIRE)–AXON Neuroscience announced the successful start of the ADAMANT phase II study, as the first patient has been vaccinated with the active tau vaccine. AXON’s vaccine, AADvac1, is intended to be the first disease-modifying tau vaccine for Alzheimer’s disease. ADAMANT PHASE II CLINICAL STUDY ADAMANT is a 24-month, …

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Pfizer Joins the Human Vaccines Project to Help Decode the Immune System

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced it will join the Human Vaccines Project (the Project), a public-private consortium focused on cross-sector collaboration to identify human immune responses associated with optimal vaccine protection. Insights gained will guide the development of potentially improved vaccines against diseases such as influenza, dengue, HIV …

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Sanofi and Merck End Joint Vaccines Venture in Europe

KENILWORTH, N.J. & LYON, France–(BUSINESS WIRE)–Sanofi Pasteur and Merck, known as MSD outside the United States and Canada, today announced their intent to end their joint vaccines operations in Europe. Upon concluding their joint venture, both companies plan to integrate their respective European vaccine businesses into their operations, independently manage …

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