Astrazeneca Shareholders Protest $1.5 Million CEO Bonus
More Exclusive FDA cGMP Compliance News It’s being called the ‘Golden Hello.’ When AstraZeneca hired Pascal Soirot hired last fall as its new ceo, the drugmaker gave the former Roche exec a healthy $1.5 million to compensate him for a bonus that he had to forfieit, along with a promise of roughly stock worth roughly $6 […]
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AbbVie Fires Hundreds
More Exclusive FDA cGMP Compliance News Now that AbbVie faces growing generic competition for a pair of top-selling heart meds, the drugmaker is the latest to find hundreds of sales reps expendable. A few hundred people wjp who toil in the cardiocare group are going the way of Willy Loman, according to Bloomberg News, which confirmed […]
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Medtronic Study Site Warned By FDA for Shocking Consent and Reporting Irregularities in Study Of CoreValve Device
More Exclusive FDA cGMP Compliance News The FDA sent a warning letter to Providence Sacred Heart Medical Center in Spokane, Washington regarding serious irregularities in its study of the Medtronic CoreValve device. The device is intended for patients with severe aortic stenosis, a condition that may lead to heart failure and sudden cardiac death. Medtronic […]
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FDA Drops Hammer on Poor Quality Generic Medicines
FDA will impose stricter guidelines to root out generic medicines in the market that are poor in quality, risky, and not effective as their branded counterparts. In an interview with ABS-CBNnews.com, FDA Acting Director General Dr. Kenneth Y. Hartigan-Go said the “quality of generic medicines has always been questioned by clinicians and the public, and […]
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Supplements Involved in Half of Drug Recalls
Dietary supplements that contain unapproved ingredients accounted for just over half of all major drug recalls in the U.S., researchers found. Analysis of FDA data showed 51% of Class I recalls over a 9-year period involved adulterated dietary supplements instead of a pharmaceutical product, Ziv Harel, MD, of St. Michael’s Hospital in Toronto, and colleagues […]
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FDA Set to Review Controversial Avandia Clinical Trial
More Exclusive cGMP FDA Compliance News Nearly three years after the FDA greatly restricted use of the controversial Avandia diabetes pill over increased risks of heart attacks and strokes, the agency is convening a two-day meeting in June to discuss an independent review of a clinical trial. The agency plans to hold the session on […]
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FDA Social Media Guidance Coming!
More Exclusive cGMP FDA Compliance News For the past few years, drugmakers have grappled with the Internet and how to promote their medicines to an increasingly interactive public. Although the FDA held a widely attended meeting in 2009 and indicated that a draft guidance would soon be forthcoming, the agency has yet to do issue […]
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Pharma Sales Reps Lie About Side Effects: Study
Exclusive cGMP and FDA Compliance News There is little, if any debate that pharmaceutical sales reps are hired to sell. The operative word in the job title, after all, is ‘sales.’ But a new study raises concern that the promotional push is crowding out some of the most important medical information that physicians need – […]
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Lilly Cuts Hundreds of Sales Reps Jobs
Exclusive cGMP and FDA Compliance News In the latest reflection of the toll the patent cliff is taking on the pharmaceutical industry, Eli Lilly plans to dismiss hundreds of sales reps tomorrow, a spokesman confirms. Earlier this week, the drugmaker held a conference call to discuss plans for eliminating reps in its BioMedicines division, which […]
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Novartis Tricked Into Buying Anti-Counterfeiting Technology!?
Exclusive cGMP and FDA Compliance News In one of the more embarrassing gaffes, Novartis was fooled into purchasing an anti-counterfeiting technology from Australia’s science agency and a marketing partner, which reportedly knew could be compromised. As a result, the drugmaker is now conducting an internal probe into the $2.5 million deal, a spokesman confirms. At […]
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