Tag Archives: vaccine

June, 2018

13 June
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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22 January
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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9 December
Personalized Cancer Vaccine is Associated with Promising outcomes for Patients with AML

A personalized cancer vaccine markedly improved outcomes for patients suffering from acute myeloid leukemia (AML), a potentially lethal blood cancer, in a clinical trial led by investigators at Beth Israel Deaconess Medical Center (BIDMC). The product of a long-term collaboration among investigators at the Cancer Center at BIDMC and Dana-Farber …
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14 November
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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24 October
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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22 June
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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3 February
FDA Grants Fast Track Status to TapImmune’s Lead Ovarian Cancer Vaccine

TapImmune, Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, announced today that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for its cancer vaccine TPIV 200 in the …
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28 October
FDA Approves Amgen’s Imlygic as First Oncolytic Viral Therapy in the US

THOUSAND OAKS, Calif., Oct. 27, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for IMLYGIC™ (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in …
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