Merck Pays $1.5M Fine For Pollution Problems
For violating several federal environmental laws at two Pennsylvania plants, Merck has agreed to pay a $1.5 million civil fine and settle charges brought by both the US Environmental Protection Agency and the US Department of Justice. Since the drugmaker has already resolved the violations, though, the feds have filed papers to dismiss their original […]
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Judge questions images for cigarette packages
A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether […]
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Drug Shortages Prompt Legislation to Help FDA Confront Problem
Medicines that are critical to fighting cancer as well as anesthetics, electrolytes for intravenous drips, and emergency drugs are facing severe shortages in the U.S. The American Hospital Association surveyed 820 hospitals this summer and found that at least half experienced shortages with more than 20 drugs, and 75 percent started rationing drugs. [1] The […]
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US generics group’s drug shortage plea
The record number of drug shortages currently ongoing in the US is a result of intensified regulatory inspections, said Paul Bisaro, chairman of the industry trade body Generic Pharmaceutical Association (GPhA) and CEO of Watson Pharmaceuticals. Speaking to the Financial Times, Bisaro said higher costs incurred by generic manufacturers due to heightened inspection efforts from […]
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Why Pharma Stocks Can Rise Before Trial Results
In a conclusion that is unlikely to surprise some investors, a new study has determined that advanced knowledge of Phase III clinical trials of new cancer meds and FDA decisions may affect the publicly traded shares prices of drugmakers. Put another way, shares in drugmakers tend to rise during the run up to reporting positive […]
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India May Cap Foreign Investment In Pharma
Will India place a cap on foreign investment in its pharmaceutical industry? The issue has been simmering ever since the Department of Industrial Policy and Promotion floated a paper more than a year ago suggesting such a move in response to an increasing number of purchases of domestic drugmakers by big pharma based overseas. A […]
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FDA Warns Website For Selling ‘Professional Cialis’
The barrage of prescription meds being peddled by websites is spurring the FDA to go after bogus operators who are apparently located in Ukraine, Panama, New York or who-knows-where. Of course, whether the warning letters issued last week to two such operators will ever be received is unclear – there is so much confusion about […]
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Surviving a new era of FDA enforcement
Receiving a Warning Letter from the U.S. Food and Drug Administration is bad enough, but when those Warning Letters are published on the agency’s Web site where companies can read, print out, and use them for competitive advantage, the “incentive†is even greater for companies to take corrective action. Since 2009, FDA’s increased power and […]
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FDA Chemist Liang Faces New Insider-Trading Charges
U.S. prosecutors filed new charges involving an alleged insider-trading scheme against a Food and Drug Administration chemist, a move the government said in earlier court papers would be the prelude to a plea agreement. Cheng Yi Liang, who worked for the FDA’s Center for Drug Evaluation and Research, was charged today in federal court in […]
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