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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FDA Still Reviewing Clot Risk for Birth Control Pills
Four months after announcing that it was reviewing the safety of certain drospirenone-containing oral contraceptives, following reports of heightened risk for blood clots, the FDA said Monday that it still had not reached a conclusion. Data from a large FDA-funded epidemiologic study have now undergone preliminary analysis and suggest a 1.5-fold increase in venous thromboembolism […]
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FDA Panel, Bayer Birth Control Pills & Blood Clots
Nearly six months after a pair of studies found that women taking birth control pills containing a hormone called drospirenone are more likely to develop blood clots than those who take an older oral contraceptive, the FDA has decided to hold an advisory panel meeting in December to review the risks and benefits. Meanwhile, the […]
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Cephalon Gets Subpoena For Treanda Marketing
The other shoe has dropped in the probe into Cephalon and its Treanda medication, which is used to treat chronic lymphocytic leukemia. The drugmaker has officially received a subpoena from the US Attorney in New Yrok requesting documents “pursuant to its authority†under the Health Insurance Portability and Accountability Act, according to a filing with […]
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