Glaxo CEO Says Europe Market ‘Much’ Worse Than Expected
GlaxoSmithKline Plc (GSK) is having a tougher time than expected generating sales in Europe as the credit crisis leads governments to cut prices, Chief Executive Officer Andrew Witty said. “What we’ve seen in the last three, four months is a much higher level of price pressure than we had anticipated, which is of course making […]
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Sanofi Exec Sentenced in Algeria for Overbilling
Source An appeals court in Algeria upheld a $25 million fine against Sanofi and a one-year suspended prison sentence for Thierry Lefebvre, its general manager in the North African nation, for overcharging for drugs and active pharmaceutical ingredients, according to media reports. Prosecutors had initially demanded a three-year sentence and a fine of up to […]
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FDA Back on Track With Approvals
Source While the latest iteration of the Prescription Drug and User Fee Act, or PDUFA V, is awaiting the Presidential signature, FDA officials are talking up their accomplishments. Specifically, the agency is taking every opportunity to remind lawmakers that its track record for approving medicines is getting better, at least according to data presented to […]
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Supreme Court Rules for ACA, Leaving Pharma Fees Intact
Source In a landmark ruling, the US Supreme Court upheld the individual insurance mandate at the heart of the Affordable CAre Act, which was the centerpiece of healthcare reform. For drugmakers and biotechs, the outcome means a degree of predictability, even though they will face billions of dollars in price cuts and fees. The initial […]
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FDA Accuses Amylin of Hiding Byetta Data
Source In a damning disclosure, an FDA official charges that Amylin Pharmaceuticals concealed a study that raised heart safety concerns about its Byetta diabetes drug and then hindered agency access to the data when it was discovered, TheStreet reports, citing newly released FDA documents. And later, Amylin execs purportedly lied to investors by failing to […]
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Evidence Grows That Celebrex Cherry Picked Celebrex Data
Source More than a decade ago, Pfizer officials crowed about the response to study data for its Celebrex painkiller in a way that may come back to haunt the drugmaker. “They swallowed our story, hook, line and sinker,†senior research director Samuel Zwillich wrote in an e-mail to a colleague. However, the results showed only […]
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Roche Cutting 1,000 US R&D Jobs
Source In the latest “streamlining†effort by a big drugmaker, Roche will close a research center in Nutley, New Jersey, and shed 1,000 jobs, which is equal to nearly five percent of its entire US workforce. The R&D activities currently headquartered in Nutley will be shifted to Basel and Schlieren in Switzerland, and Penzberg, Germany. […]
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FDA Bashes Stem Cell Firm for Violations
Source Four months ago, a bioethics professor at the University of Minnesota asked the FDA to investigate a stem cell company called Celltex Therapeutics, which has ties to a controversial stem cell company in South Korea called RNL BIO, over concerns about patient-client safety, the quality of scientific research supporting their proposed business model and […]
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Merck Serono confirms Geneva closure, creates start-up fund
Merck KGaA has confirmed the planned closure of its Merck Serono headquarters in Geneva, Switzerland, plus a site in Coinsins, but has also unveiled a 30 million euro start-up fund for employees. The move to shutter Geneva, which will see 500 jobs go, met with considerable resistance in Switzerland and strikes were threatened. Merck held […]
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Pfizer Concludes Social Media Efforts for Trial Recruitment With Poor Results
source A closely watched effort to use social media almost exclusively to recruit patients for a clinical trial has come to a disappointing end. One year after launching its so-called clinical-trial-in-a-box, Pfizer is discontinuing enrollment in the first such study that was designed to allow patients to participate from home by using computers and smartphones […]
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