Feds Probe Cephalon For Off-Label Treanda Promotion
Just as Teva Pharmaceuticals hopes to wrap up its $6.2 billion acquistion of Cephalon, the biotech has been asked by the feds about documents relating to alleged off-label promotion of its fast-growing Treanda medication, which is used to treat chronic lymphocytic leukemia and racked up $117 million in sales in the first quarter of the […]
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Abbott Uses Fear To Promote Sleeping Pills In India
To promote its Zolfresh sleeping pill in India, Abbott Laboratories has embarked on an advertising campaign that is being harshly criticized for using unproven data and old-fashioned fear in the guise of educating consumers about insomnia. Moreover, critics say the ads may prompt some people to buy potentially harmful pills that are not really needed, […]
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Pfizer To Shed Animal Health & Nutrition Units
Source: Pharmalot.com After months of speculation and debate, Pfizer is now looking to sell or spin off its Animal Health and Nutritional businesses, although the drugmaker has apparently had a change of heart about its Consumer Health operation and appears committed to keeping the unit. The move comes after Pfizer signaled its intention several months […]
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FDA’s Drug-Approval Rate for 2011 on Pace to Exceed 2010
The Food and Drug Administration has approved 20 new drugs so far this year, just one short of the total for all of 2010, according to a top agency official. The pace likely puts the FDA on track to approve more new types of drugs in 2011 than the previous few years. In testimony before […]
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FDA Warns Cadila Over Incompetent Microbiologists
Yet another facility run by an Indian drugmaker has been tagged by the FDA. The latest belongs to Cadila Healthcare, which was cited by the FDA for failing to follow good manufacturing practices at a new facility designed to make injectable meds for sale in the US. More specifically, a June 21 warning letter cited […]
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Pfizer Guts R&D – Questions Arise
Source: Pharmalot.com Over the past few years, Pfizer has made news not for startling discoveries, but instead for slashing key areas of R&D, closing facilities and laying off thousands of employees. The moves have cut billions of dollars in expenses, a process that was hastened by the acquistion two years ago of Wyeth. Just last […]
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FDA Bans Dr. Reddy’s Imports from Mexican Plants
The FDA has banned product imports made at a Dr. Reddy’s facility in Mexico. The facility, Industrias Quimicas Falcon de Mexico, produces active pharmaceutical ingredients and intermediates. It received an FDA warning letter last month. The import ban is a “detention without physical examination” of the products, according to an FDA notice, an action sometimes […]
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FDA Attempting to Regulate Dietary Supplements
Source: Pharmalot.com The Food and Drug Administration has taken hits over their lack of regulation for dietary supplements, but are taking steps to rein in the booming industry in an attempt to safeguard consumers. The FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products (prescription and […]
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Russian Police Search Novartis & Teva Offices
Russian police have searched the offices of four drugmakers in Moscow, including Novartis and Teva Pharmaceuticals, according to Reuters, which cited the Vedomosti web site, which quoted a police source as saying the searches were carried out as part of an investigation into an alleged carve-up of the market for supplying the state healthcare system […]
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Protocols and planning key to avoiding warning letters; FDA
Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA. In 2010, 95 per cent of US Food and Drug Administration (FDA) warning letters were related to the protocol. By designing a good protocol, identifying the goal of the trial, the risks involved, and sticking […]
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