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Elan Eliminates More Than 100 Jobs

Source: Pharmalot.com Following the recent decision to sell its drug manufacturing unit to Alkermes for $960 million, Elan is eliminating 104 jobs from a Pennsylvania facility that is part of the deal, according to a notice filed with the Pennsylvania Department of Labor . The jobs will be gone next month and the facility is […]

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Cadila to see marginal impact of USFDA warning letter

Cadila Healthcare recently received a warning letter from the US Food and Drug Administration (USFDA) with regard to the company’s Gujarat plant. Cadila is said to have violated the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at its facility in Gujarat. Chirag Talati, pharma analyst at Espirito Santo Securities tells CNBC-TV18 that since […]

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J&J Faces Misdemeanor For Natrecor Marketing

Source: Pharmalot.com Federal prosecutors have charged the Johnson & Johnson Scios unit with mislabeling the acute heart failure drug Natrecor. In a filing in federal court in California, the feds say labeling “lacked adequate directions for use” between 2001 and 2005. J&J was charged with a single misdemeanor and faces a fine of $200,000, or […]

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Pharma Execs Confess Innovation Is Lacking

Source: Pharmalot.com When the going gets tough, do the tough know now to innovate? Apparently not. At least that’s what a bunch of pharma execs confess in a new survey that finds only 54 percent – including those who admit to having poor or ineffective innovation strategies – consider innovation to be a leading priority. […]

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Alzheimer’s Clinical Trial Rules Are Loosened

Source: Pharmalot.com A group of academic and industry experts has convinced the FDA to ease safety restrictions on clinical trials for Alzheimer’s drugs, which were imposed after a 2008 study of a developing med found cases of a brain-swelling condition known as vasogenic edema. That undermined confidence in the safety of drugs focusing on reducing […]

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Pfizer, J&J’s Alzheimer’s Drugs To Get Boost from FDA Trial Rules

There are no good drugs yet for treating Alzheimer’s disease, which is notoriously complex and poses many challenges to developers. Yet with the nudging of industry and academics, the FDA has loosened some safety restrictions on trials for amyloid-lowering drugs against the disease, making it that much easier for companies like Pfizer, J&J and Eli […]

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Takeda Pulls Actos In France Over Bladder Cancer

Source: Pharmalot.com One month after French regulators suspended the use of the Actos diabetes pill after a review of pharmacovigilance data showed an increased risk of bladder cancer, Takeda Pharmaceuticals has withdrawn the drug. The Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) also asked Takeda to withdraw a related brand called Competact. […]

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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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