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- FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine.
- BETHESDA, Maryland, January 25 /PRNewswire/ -- BETHESDA, Maryland, January 25 /PRNewswire/ --
- Research articles 2007-01-25
- FDA Vaccines Advisory Committee Unanimously Agrees That Clinical Data from 70,000-Infant Phase III Trials Support the Efficacy and Safety of ROTATEQ®, Merck's Investigational Vaccine for Rotavirus Gastroenteritis
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee voted unanimously that the data from the Phase III clinical trials with 70,000 infants support the efficacy and safety of ROTATEQR (rotavirus vaccine, live, oral,...
- Research articles 2005-12-14
- FDA Advisory Committee Agrees That Clinical Data Support the Efficacy and Safety of Zostavax™, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee agreed that the extensive data from clinical trials in more than 40,000 people support the efficacy and safety of ZOSTAVAXTM (zoster vaccine live (Oka/Merck)), the...
- Research articles 2005-12-15
- FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of GARDASIL®, Merck's Investigational Cervical Cancer Vaccine; If Approved, GARDASIL Will Be the First Cervical Cancer Vaccine in the U.S
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee voted unanimously that the data from Phase II and Phase III clinical trials support the efficacy and safety of GARDASILR (quadrivalent human papillomavirus (Types 6,...
- Research articles 2006-05-18
Additional Resources
- North American Vaccine Announces Update On FDA Advisory Committee Meeting
- BELTSVILLE, Md.--BUSINESS WIRE--Nov. 26, 1996--North American Vaccine (AMEX:NVX) maintains its policy of not commenting on interactions with the U.S. Food and Drug Administration ("FDA") in, or the status of, the FDA's review of the company's products or on rumors or press reports appearing in the media regarding the business operations...
- Research articles 1996-11-26
- FDA Advisory Committee Concludes ACEL-IMUNE, Acellular Pertussis Vaccine Safe and Effective for Infant Use
- ST. DAVIDS, Pa.--HealthWire--Oct. 29, 1996--Wyeth-Lederle Vaccines and Pediatrics, a unit of Wyeth-Ayerst Laboratories, announced today that the Food and Drug Administration's FDA Vaccines & Related Biological Products Advisory Committee concluded that ACEL-IMUNER Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbeda is safe and effective when given to U.S. infants...
- Research articles 1996-10-29
- Rotarix® Receives Favorable Recommendation from FDA Advisory Committee
- NEEDHAM, Mass. -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today announced that Rotarix([R]), an oral, two-dose rotavirus candidate vaccine to prevent rotavirus gastroenteritis in infants, received a favorable recommendation from the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee VRBPAC. AVANT licensed the technology for Rotarix([R])...
- Research articles 2008-02-21
- Hill: FDA lax on conflict-of-interest rules
- The FDAs advisory committee conflict-of interest rules have been lax, says a House Government Reform Committee staff report. While the report hints at a broader scope of FDA problems with managing conflict-of interest issues, it narrows its focus to conflict-of interest issues within the agency's vaccine approval process. The report...
- Research articles 2000-10-01
- GlaxoSmithKline Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionKevin Wilson - Citigroup Yeah, thank you this Kevin Wilson from Citigroup in London. Three questions, if I may, JP. Firstly, in the U.S., the 2% decline in sales in the quarter. Could you break out the volume and any price element you saw, and perhaps also comment...
- Earnings calls 2007-07-25
- Is Merck's Gardasil Linked To Lou Gehrig's Disease?
- Merck's Gardasil made big news late last week - and it wasn't all good. First, the FDA endorsed the vaccine to thwart genital warts in boys and young men. This is a mild plus for the drugmaker; Gardasil is already approved to ward off the human papillomavirus, or HPV, in...
- News items 2009-10-22
- How Much Is Dendreon Worth?
- Dan Grundig submits: Before diving into the valuation process, here is a quick recap of recent Provenge history, and what to expect in the near future. Provenge, developed by Dendreon Corporation DNDN, is an active cellular immunotherapy (i.e. vaccine) for treatment of metastatic, androgen independent prostate cancer...
- External links 2009-04-19
- Glaxo's U.S. Cervarix Approval More Important for Company's Pride than for Sales
- EP Vantage submits: GlaxoSmithKline GSK finally appears set to win approval for its cervical cancer vaccine Cervarix in the US, an event that could now occur in a couple of weeks' time and bring a long and tortuous journey to a conclusion. Having first filed the vaccine in March...
- External links 2009-09-11
- Cervarix gets CDC nod; Gardasil-for-boys slighted
- The HPV vaccine saga continues. Less than a week after we got the FDA nod on GlaxoSmithKline's Cervarix shot and a new use in males for Merck's Gardasil, the Centers for Disease Control and Prevention has weighed in. And though the public-health agency sided with FDA on Cervarix, it wasn't...
- News items 2009-10-22
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