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US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteurs Investigational Pediatric Hexavalent Vaccine
2014-10-20 14:00:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa. Phase III clinical study data presented at IDWeek in Philadelphia WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and NYSE:SNY), announced today that the Biologics License Application (BLA) filed for the companies investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA). Language: English Contact: MerckMedia:Deb Wambold, (215) 652-2913orInvestors:Justin Holko, (908) 423-5088orSanofi PasteurMedia:Susan Watkins, (570) 957-2563susan.watkins@sanofipasteur.comorInvestors:George Grofik, (908) 981-5560IR@sanofi.com Ticker Slug: Ticker: MRK Exchange: NYSE Ticker: SAN Exchange: BOURSE Ticker: SNY Exchange: NYSE read more
Tags: review
application
license
accepts
FDA panel votes to keep boxed warning on Chantix
2014-10-17 08:54:16| Biotech - Topix.net
Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning about reports of suicide, hostility and depression among Chantix patients.
Tags: panel
votes
warning
boxed
FDA approves 2 drugs for deadly lung disease
2014-10-16 05:12:59| Biotech - Topix.net
A federal health official says the Centers for Disease Control and Prevention cleared a nurse who has Ebola to fly from Cleveland, Ohio, to Dallas. A federal health official says the Centers for Disease Control and Prevention cleared a nurse who has Ebola to fly from Cleveland, Ohio, to Dallas.
Tags: disease
drugs
lung
deadly
FDA will ask advisers whether Chantix's bolded suicide warning should be dropped from label
2014-10-14 20:06:04| Biotech - Topix.net
The Food and Drug Administration will ask a panel of experts later this week whether a bold-letter warning on the anti-smoking drug Chantix should be removed based on company-supported evidence that the drug does not cause suicidal behaviour. Pfizer's twice-a-day tablet has carried the FDA strongest warning label, known as a black box, since 2009 because of reports of suicidality, hostility and depression.
Tags: from
label
warning
dropped
FDA: Increase in Antibiotics Use in Animals
2014-10-13 17:08:00| National Hog Farmer
P. Scott Shearer, Bockorny Group, Washington, D.C. According to the Food and Drug Administrations latest annual report on sales and distribution data on antibiotics approved for use in food-producing animals, antibiotics sold for use by the livestock industry, including in animal feed, increased by 16% in four years (2009-12). read more
Tags: increase
animals
fda
antibiotics
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