Posts Tagged 'GlaxoSmithKline'

Zostavax Competitor Wins Unanimous Recommendation for Approval

shingrix wins approval recommendationAfter considering the data, every member of an FDA advisory panel convened this month voted to recommend the approval of Shingrix – a new shingles vaccine developed and marketed by GlaxoSmithKline.

Data was not based solely on efficacy, or effectiveness. Rather, the data also took the vaccine’s safety into consideration. Panel members were “very impressed” with that data on both fronts and – according to Reuters – believe that Shingrix is ...

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GSK Official May Have Been Fired in Whistleblower Retaliation

gsk firing may have been whistleblower retaliationSome would say that when the manager of biostatistics of a multi-billion-dollar pharmaceutical corporation tells you that there is something wrong with the data you’re using to bring a drug to market, you might want to listen to that person. However, if allegations in a new lawsuit against GlaxoSmithKline are proven true, the other option is to try to get away with firing the biostatistician and move on.

Such are the ...

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Zofran Maker Wants MDL for Birth Defect Lawsuits

GSK asks for Zofran MDLReuters reports that Zofran maker GlaxoSmithKline has asked the U.S. Judicial Panel on Multidistrict Litigation to centralize all pending Zofran birth defect lawsuits in a multidistrict litigation. The pharmaceutical giant has requested the Zofran lawsuits be consolidated in federal court in Pennsylvania, near the company’s U.S. headquarters.

Zofran is an antiemetic drug used to treat nausea and vomiting in chemotherapy, radiation therapy, and surgery patients. Zofran is also frequently prescribed to ...

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GlaxoSmithKline Files to Create Zofran MDL

GSK files to consolidate zofran casesRecognizing the number of cases currently filed against it; and the potential for a significant number more, pharmaceutical giant GlaxoSmtihKline has requested that all Zofran birth defect lawsuits be consolidated into one multi-district litigation, or MDL.

MDLs are generally used as a tool for increasing the efficiency of of legal proceedings when a number of similar lawsuits are filed. When a large number of lawsuits are filed across a range of locations ...

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FDA to Implement New Drug Safety Labeling System for Pregnant Women

FDA to issue new warnings on drug birth defectsThe U.S. Food and Drug Administration (FDA) has announced it will switch to a new drug safety labeling system that will provide more information to pregnant women and their doctors, the Chicago Tribune report. According to the article, this revision to prescription guidelines will be the first since 1979.

The new drug safety labeling system will replace the current A–X grading scheme and provide more detailed information ...

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New Study Finds Possible Link between Zofran and Child Deaths

zofran linked to deaths of childrenA new study published in Pediatric Emergency Care has found a possible connection between the antiemetic drug ondansetron, marketed as Zofran, and the deaths of two children.

The study reports on two cases of fatal cardiac arrest that occurred in children after they were given Zofran. One of the children, a 10-year-old boy with no previous health conditions, was admitted to the emergency room with stomach flu symptoms. After extensive emergency ...

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