Posts Tagged 'GlaxoSmithKline'

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 ...

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FDA Drug Approvals Hit 18 Year High

In 2014, the FDA Center for Drug Evaluation and Research approved the most drugs since 1996. The FDA approved 41 novel medications last year, 62% more than the 27 approved in 2013. The only year that topped 2014 was 1996, when 53 new drugs were approved.

The new drug approvals consisted mostly of innovative, expensive treatments where competition is limited and costs of treatment can often exceed $100,000 per patient per year. Infectious ...

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GSK Warned over Vaccine Plant

GlaxoSmithKline received a warning from the U.S. Food and Drug Administration about the conditions at its manufacturing facility in Quebec. The FDA said that the plant violated quality requirements during the manufacturing of its influenza vaccine Flulaval.

The FDA sent a letter to the company on June 12 after an inspection of the plant earlier this year. The investigation found that GSK had not established and followed written procedures to prevent microbiological contamination of ...

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Foreign Investigators Linked to GlaxoSmithKline Indicted

Chinese prosecutors have indicted a foreign couple for the illegal collection of personal information by their private firm on behalf of drugmaker GalxoSmithKline last year. This is the first indictment announced by Chinese prosecutors of foreigners conducting an illegal investigation.

The couple, a 58 year old U.K. man and a 61 year old U.S. citizen, were indicted for illegally tracking personal information that had been obtained through hidden photography and “infiltration.” The data that was collected ...

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GlaxoSmithKline to Pay $105 Million Settlement

GlaxoSmithKline paying 105 million dollar fine over false marketing claimsGlaxoSmithKline, a London-based pharmaceutical company, agreed to pay a $105 million settlement to 44 states and the District of Columbia. The company was allegedly unlawfully marketing Advair, its asthma drug, and two popular antidepressants.

The lawsuits claimed that GlaxoSmithKline was using off-label marketing and violated state consumer protection laws. Off-label marketing is when a company markets a drug for uses that are not approved by ...

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Pfizer Pays $450 Million to Settle Unlawful Marketing Claims

Patient safety is greatly compromised when financial incentives interfere with crucial medical decisions. The Wall Street Journal reports how two pharmaceutical sales representatives exposed unlawful marketing practices regarding the immunosuppressant drug, Rapamune.

Pfizer and its subsidiary, Wyeth Pharmaceuticals faced a lawsuit under the Federal False Claims Act for actively marketing Rapamune for non-FDA-approved uses as well as paying kickbacks to prescribers.

In paying kickbacks to physicians, pharmaceutical companies manipulate honest and helpful medical advice. This practice could influence a doctor’s ...

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