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Fewer Consumers Able to Afford Pharmaceutical Purchases

Source And the answer is, not surprisingly, a lot of folks are having some trouble. A new survey finds that more than half of those queried – and 84 percent under the age of 65 without a drug benefit – say they pay for their medications by cutting other household expenses or changing how they […]

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J&J Hires Bayer Executive to Run Compliance-Troubled Units

Source   In his biggest personnel shift since become Johnson & Johnson ceo this spring, Alex Gorsky has hired Bayer executive Sandra Peterson as a so-called group worlwide chairman and a member of the executive committee. Her responsibilities will include overseeing the troubled consumer health unit and manufacturing operations, which have haunted the health care […]

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Novartis and Mayor Spar Over Superfund Site

source   Nearly a decade ago, a landfill that is located just a few miles from the sprawling Novartis US headquarters campus was declared a Superfund site. Known as Rolling Knolls, the former dumping ground covers about 200 acres and is bounded by the leafy New Jersey suburb of Chatham Township and a national wildlife […]

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Biotech CEO Is Fighting Exclusion by DHHS

Yet another pharmaceutical industry executive is fighting a move by the US Department of Health & Human Services to exclude him from participating in federal healthcare programs. The latest to go to court is W. Scott Harkonen, who once headed InterMune and was sentenced earlier this year for wire fraud in connection with disseminating false […]

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Sun Pharma Still Has FDA Problems

source Late last month, Sun Pharma happily declared that its Caraco unit was finally in compliance with good manufacturing practices after receiving notice from the FDA. This meant that two manufacturing and packaging facilities in Michigan were able to resume limited operations after various inspections and so-called 483 reports had been issued by the agency. […]

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PDUFA Could Unravel Because of Budget Gridlock

Source Three months after the latest version of the Prescription Drug and User Fee Act went into effect, the all-important legislation may come undone thanks to wrangling among lawmakers over budget cutbacks, Bloomberg Newsreports. And so, a large appropriation is at risk that may cause drug reviews to slow or come to a stop in […]

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J&J Settles Law Suit Regarding Male Breasts

Source   Was Johnson & Johnson worried what would happen when Aaron Banks took the stand to testify that its Risperdal antipsychotic allegedly caused him to grow breasts? Just as a trial in a Pennsylvania state court was about to begin, the health care giant settled the case, the first of dozens of such lawsuits […]

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Sanofi Has Setback With Dengue Vaccine

source   Two months ago, Sanofi issued a press release indicating results of a widely awaited vaccine to prevent dengue fever, which is estimated to threaten some 3 billion people worldwide, demonstrated proof of efficacy. Late last night, though, study results were published in The Lancet showing something quite the opposite – the vaccine was […]

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Novartis Struggles on Quality

source For Novartis execs, the old cliche that ‘if it’s not one thing, it’s another,’ is becoming quite true. For the past year, the drugmaker has struggled to get a handle on manufacturing problems at several plants around the world, which have attracted scrutiny from regulators. The latest mishap occurred in Rosia, Italy, where a […]

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FDA Sued For Dosage of Alzheimer’s Medication

source A public watchdog has filed a lawsuit against the FDA for allowing a high dosage of the Aricept medication for Alzheimer’s disease to remain on the market. In its suit, Public Citizen charges the pill has not demonstrated “greater efficacy than the lower doses, but has more severe — and potentially life-threatening – side […]

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