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Vaccines & Immunizations

Emergent BioSolutions to Acquire Specialty Vaccines Company PaxVax

GAITHERSBURG, Md., Aug. 13, 2018 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement to acquire PaxVax, a company focused on specialty vaccines that protect against existing and emerging infectious diseases, for an all-cash consideration of $270 million. PaxVax is majority owned …

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FDA Grants Priority Review to Merck’s sBLA for Gardasil 9 for Prevention of HPV-Related Cancers and Diseases

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. The application is seeking …

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FDA Grants PaxVax Fast Track Designation for its Chikungunya Vaccine

REDWOOD CITY, Calif., May 4, 2018 /PRNewswire/ — PaxVax, a leading independent specialty vaccine company, announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its vaccine for the prevention of disease caused by the chikungunya virus. Chikungunya represents a significant public …

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Moderna and Merck Expand mRNA Cancer Vaccines Collaboration

CAMBRIDGE, Mass. and KENILWORTH N.J., May 3, 2018 — Moderna Therapeutics and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced an expansion of their 2016 collaboration to develop and commercialize novel personalized messenger RNA (mRNA) cancer vaccines to now include shared antigen mRNA cancer vaccines including …

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FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that TRUMENBA® (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. This is the first Breakthrough Therapy designation …

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Astellas and Vical’s Investigational Cytomegalovirus Vaccine Fails in Late-Stage Trial in Hematopoietic Stem Cell Transplant Recipients

TOKYO and SAN DIEGO, Jan. 22, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Vical Incorporated (NASDAQ: VICL) announced today that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) recipients, did not meet its primary or …

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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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