Corden Pharma Colorado lays off 60
Drug manufacturer Corden Pharma Colorado Inc. said Friday it would lay off 60 of its 260 workers as the company focuses on its new roles in contract manufacturing and development. Corden Pharma Colorado in Boulder is the former Roche Colorado Corp., which was renamed after Frankfurt, Germany-based International Chemical Investors Group acquired the manufacturer of […]
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FDA plans QbD for clinical trials to cut industry & regulatory monitoring costs
The FDA is working on quality-by-design (QbD) for clinical trials to cut oversight costs for industry and regulators.
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Amgen To Lay Off Nearly 400 Employees
A short while ago we wrote how Amgen hired away an exec from Bristol-Myers Squibb as part of its reorganization. Well, some additional news is now coming in and the biotech is eliminating several hundreds of jobs from its workforce, which currently number about 17,600 worldwide. As noted last week, the biotech indicated to its […]
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CRO Employees Plead Guilty To Falsifying Data
A doctor and a clinical research coordinator who worked for a contract research organization hired by the former Schering-Plough have pleaded guilty to conspiring to defraud the drugmaker by falsifying study data. They also pleaded guilty to failing to maintain records as required by the FDA. The clinical trial, by the way, was designed to […]
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FDA Chemist Pleads Guilty to Insider Trading
Seven months after his scheme came to light, FDA chemist Cheng Yi Liang pleaded guilty today to charges that he used confidential information about upcoming announcements of 27 different FDA approval decisions involving 19 publicly traded companies and generated more than $3.6 million in illegal profits for himself. The 57-year-old Liang pleaded guilty to one […]
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Business Owner to FDA Auditor: Quality Policies Are All in His Head
Some people can remember anything. Take James Jacobson. He owns X-Ray Support, which sells dental x-ray automatic film processors. No, this is not a prescription drug or anything close. But consider his response to an FDA inspector who visited his Spokane Valley, Washington, facility last May. The answer is just the sort of reply to […]
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Those Quality Procedures Are All In His Head?
Some people can remember anything. Take James Jacobson. He owns X-Ray Support, which sells dental x-ray automatic film processors. No, this is not a prescription drug or anything close. But consider his response to an FDA inspector who visited his Spokane Valley, Washington, facility last May. The answer is just the sort of reply to […]
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Jazz Pharma To FDA: What Patient Deaths?
Blaming your contracted distributor for failing to report serious adverse events, such as patient deaths, on a timely basis is probably not a sound strategy when offering explanations to the FDA. Consider Jazz Pharmaceuticals, which was tagged by the agency for failing to report at least 10 patient deaths, but insisted fault lay with its […]
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FDA Chemist Pleads Guilty To Insider Trading
Seven months after his scheme came to light, FDA chemist Cheng Yi Liang pleaded guilty today to charges that he used confidential information about upcoming announcements of 27 different FDA approval decisions involving 19 publicly traded companies and generated more than $3.6 million in illegal profits for himself. The 57-year-old Liang pleaded guilty to one […]
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Abbott To Split: Two Pharma Are Better Than One?
In a bid to unlock the perceived value in product line-up and geographic markets, Abbott Laboratories plans to separate into two publicly traded companies. The move is the latest gambit by a big drugmaker to reinvent itself on the premise that its growth potential is hampered by investors who have failed to appreciate a diverse […]
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