Synthes gets warning letter from FDA
Synthes Inc., the medical device manufacturer with U.S. headquarters in Chester County, is in more trouble with the U.S. government. Four former Synthes executives were sent to federal prison last fall for their roles in an illegal clinical trial of bone cement. Last month, the company was sent an unrelated Food and Drug Administration warning […]
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FDA Issues Warning On ‘Breathable’ Caffeine
The Food and Drug Administration has warned a company that markets caffeine and vitamin B as “breathable energy” it could face regulatory action over “false and misleading” labeling. AeroShot comes in a lipstick-shaped dispenser that puffs out the white powdery mixture. Pre-filled devices can be purchased online or in convenience stores in New York and […]
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Pfizer Exec Gets Green Light to Sue Over Dirty Trial Data
Source: Pharmalot A former Pfizer oncology director has been given a green light by a federal judge to pursue a whistleblower lawsuit against the drugmaker over claims that allegedly ‘dirty data’ was being hidden from the FDA. And the judge struck down a Pfizer argument that the former employee, who claimed she lost her job […]
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Crime Doesn’t Pay: Former FDA Chemist Life in Tatters For Insider Trading
Source: Pharmalot One year after his scheme was discovered, FDA chemist Cheng Yi Liang was sentenced to five years in prison for insider trading. Liang, 58, used confidential information about upcoming announcements of 27 different FDA approval decisions involving 19 publicly traded companies over a five-year period, and generated more than $3.7 million in illegal […]
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Ex-FDA chemist gets 5 years in prison for insider trading
Cheng Yi Liang endured forced labor during China’s Cultural Revolution, earned a doctorate in the United States and built a life in Gaithersburg as a chemist at the Food and Drug Administration. He was also extraordinarily successful at playing the stock market. But on Monday, Liang, 58, stood before a federal judge and was sentenced […]
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FDA asks Merck for more data on its new combination cholesterol drug
Merck & Co. is trying to improve its place in the cholesterol drug market but its latest attempt faces another hurdle. The U.S. Food and Drug Administration, according to Merck, said the company needed to provide more data before the agency could further consider an application for a new drug that combines Merck’s cholesterol drug […]
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Sanofi CEO Blasts….Scientists? Huh?
Source: Pharmalot Who needs those pesky scientists? At least those who work at big pharma? After all, the best ones want to work at smaller biotechs, right? And those left behind have no idea how to innovate. Says who? Chris Viehbacher, that’s who. The Sanofi ceo let loose at the CED Life Sciences Conference this […]
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FDA Wants Three Years of Heparin Test Results from APP Pharma
APP Pharmaceuticals ($APPX) has had its production of heparin called into question in an FDA warning letter and has been ordered to present three years worth of out-of-specification results for heparin and heparin lock flush. The letter, dated Feb. 22 but posted this week, said APP, a subsidiary of Fresenius Kabi ($FRE), did not identify, […]
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GSK Pulls Drug Manufactured at Troubled Novartis Plant
GlaxoSmithKline ($GSK) is the latest victim of a contract-manufacturing snafu. The company has recalled 394,230 bottles of its DynaCirc CR blood pressure drug over fears that other tablets made at the same plant might have been mixed into the packages. The plant in question is a Novartis ($NVS) facility in Lincoln, NE, that’s currently on […]
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Beware Spinning Toothbrush of Death
When you’re using a toothbrush, you don’t expect it to chip a tooth, poke your eye or pose a choking hazard. But that’s just what the U.S. Food and Drug Administration is warning consumers some battery-powered “spinning†toothbrushes may do. In a statement issued Thursday, the FDA cautioned about what the Arm & Hammer Spinbrush […]
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