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Vaccines & Immunizations

Merck Receives Breakthrough Therapy Designation from FDA for V114, Investigational 15-Valent Conjugate Vaccine for Prevention of Invasive Pneumococcal Disease

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the …

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Takeda’s Dengue Vaccine Candidate Meets Primary Endpoint in Pivotal Phase 3 Efficacy Trial

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE:4502 / NYSE:TAK] (“Takeda”) today announced that the pivotal Phase 3 trial of its dengue vaccine candidate met the primary efficacy endpoint. This first analysis of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the company’s investigational live-attenuated tetravalent dengue …

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FDA Approves Use of 0.5 mL Dose of Fluzone Quadrivalent in Children as Young as 6 Months of Age

BRIDGEWATER, N.J., Jan. 23, 2019 /PRNewswire/ — The U.S. Food and Drug Administration has approved the use of the 0.5 mL dose of Fluzone®Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Sanofi Pasteur, the vaccine division of Sanofi, will have the 0.5 mL dose, in addition to the 0.25 mL …

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FDA Approves Expanded Use of Adacel Vaccine for Repeat Vaccination

BRIDGEWATER, N.J., Jan. 14, 2019 /PRNewswire/ — The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria and pertussis. It is now the first and only Tdap vaccine in the …

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FDA Approves Vaxelis, Sanofi and Merck’s Pediatric Hexavalent Combination Vaccine

PARIS and KENILWORTH, N.J. – December 26, 2018 – The U.S. Food and Drug Administration has approved VAXELIS(TM) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th …

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Emergent BioSolutions and Valneva Report Positive Phase 1 Results for Their Vaccine Candidate Against the Zika Virus

GAITHERSBURG, Md. and SAINT-HERBLAIN, France, Nov. 19, 2018 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) and Valneva SE (VLA) today announced positive interim results for the Phase 1 study evaluating VLA1601, their vaccine candidate against the Zika virus. The highly purified inactivated vaccine candidate, VLA1601, met the study’s primary …

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FDA Grants Breakthrough Therapy Designation to Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and …

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Gilead and Precision BioSciences Collaborate to Develop Therapies Against Hepatitis B Virus Using ARCUS Genome Editing

FOSTER CITY, Calif. & DURHAM, N.C.–(BUSINESS WIRE)–Gilead Sciences (Nasdaq: GILD) and Precision BioSciences announced today that the companies have entered into a strategic collaboration to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform, ARCUS. An estimated 257 million people are living with …

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Large Study Finds HPV Vaccination Does Not Negatively Impact Fertility in Adolescents

PORTLAND, Ore., Aug. 21, 2018 /PRNewswire/ — Adolescents who receive recommended vaccinations, including for human papillomavirus (or HPV), have no increased risk of primary ovarian insufficiency, also known as premature menopause, according to a Kaiser Permanente study published today in Pediatrics. Rates of HPV vaccination have lagged behind coverage rates …

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BioNTech Enters Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza

MAINZ, Germany & NEW YORK–(BUSINESS WIRE)–BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of …

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