Feds Bring Subpoena on Bristol Myers Regarding Marketing for Abilify
Source: Pharmalot In September 2007, Bristol-Myers Squibb agreed to settle charges of giving kickbacks to docs and overcharging the government. Among the infractions alleged by the federal and state governments was off-label promotion of its Abilify antipsychotic, and the drugmaker subsequently paid $515 million and signed a five-year corporate integrity agreement. Could there have been […]
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Novartis Stops Parts of Production at Yet Another Manufacturing Plant
Source: Pharmalot For the second time in less than three months, Novartis has been forced to halt production of medicines at one of its plants after recent FDA inspections found various manufacturing problems. This time, its Sandoz unit has suspended or discontinued production of some medicines at a facility in Boucherville, Quebec. In December, all […]
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Fake Avastin Causing Major Uproar in National Media
Source: Pharmalot For the past couple of days, the controversy over counterfeit Avastin – the cancer med sold by Roche and its Genentech unit – has made national headlines and renewed fears about phony meds making their way through the supply chain. The timing could not be worse, coming just as the crisis over assorted […]
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Trade Group CEO in Pakistan Resigns in Disgust
Source: Pharmalot Over the past month, the Pakistani pharmaceutical industry has been roiled by a scandal in which at least 130 people died after taking a contaminated heart medication. Yesterday, however, the acting chair of the Pakistan Pharmaceutical Manufacturers Association added some drama to the episode by reading a statement at a press conference – […]
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J&J the Victor in Its First Risperdal Product Liability Suit
Source: Pharmalot In the first lawsuit to go to trial over personal injuries attributed to the Risperdal antipsychotic, a New Jersey jury decided in a 5-to-1 vote that the Johnson & Johnson drug was not a substantial factor in causing a 56-year-old man to develop diabetes. However, the jury also voted 5-to-1 that the health […]
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Gilead Getting Hosed on $11 Billion Hep C Deal
Source: Pharmalot Three months after agreeing to pay an eye-popping $11 billion to buy Pharmasset and gain a lock on the lucrative Hepatitis C market, Gilead Sciences had the unpleasant task this morning of disclosing that its first announcement to stem from the controversial deal has nothing but bad news. Why was the deal a […]
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Former FDA Commissioner Offers Strange Idea: Test Efficacy in Post-Marketing
File this under ‘What was he thinking?’ In an op-ed in The Wall Street Journal, former FDA commish Andy von Eschenbach proposes that the “FDA should approve drugs based on safety and leave efficacy testing for post-market studies.†How would this work? Well, Andy suggests creating pilot programs in which patients would be entered in […]
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OSC Now Involved Over Probe on FDA Employee Whistleblowers
Source: Pharmalot The probe into the sensational charges that the FDA secretly monitored several former and current employees, and then harassed and dismissed some of them, has now widened. The Office of Special Counsel, which is an independent federal investigative and prosecutorial agency, is also investigating. This follows a probe opened by the House Committee […]
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Merck Receives Unusual, Holistic Warning Letter from FDA
Source: http://www.pharmalot.com/ In what appears to be a calculated review of a supply chain, the FDA last summer inspected three Merck KGgA manufacturing plants in Europe – one that makes active pharmaceutical ingredients, another that makes finished prescription drugs and a third that is responsible for testing meds for the US market – and all […]
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J&J Reputation Going Down the Tubes
Source: Pharmalot The latest corporate reputation poll from Harris Interactive is out and the results for Johnson & Johnson are not so good. This is a classic a case of the glass being half full or half empty. On one hand, the health care giant ranked 7th, which is not too shabby. Yet, this was […]
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