Judge Slams Roche for Recusal Request
In rather stark terms, a New Jersey state court judge recently rejected a request by attorneys for Roche who accused her of bias in long-running and sprawling litigation over the Accutane acne medication. And in her remarks, Superior Court Judge Carol Higbee maintains that she has worked hard to appear even-handed despite several instances in […]
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Impax Shares Plummet as FDA Finds Manufacturing Issues
Impax Laboratories Inc. (IPXL), the developer of the experimental drug Rytary for Parkinson’s disease, fell the most in almost three years after regulators found that manufacturing issues persist at a company plant. Impax declined 25 percent to $15.03 at 11:03 a.m. New York time, after falling to $14.88 in the biggest intraday drop since May […]
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FDA flags new concerns on Hospira’s Rocky Mount plant
Hospira Inc said U.S. health regulators raised fresh concerns about the injectable-drugs maker’s troubled Rocky Mount, North Carolina manufacturing plant – one of its largest production facilities. The much-awaited outcome of the FDA re-inspection of the plant did not provide significant additional clarity for the stock, Morgan Stanley analyst Marshall Urist wrote in a note. […]
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Pfizer settles 80 percent of more than 2,700 lawsuits claiming problems with smoking cessation drug Chantix
Pfizer Inc. has settled about 80 percent of the more than 2,700 lawsuits filed against it in federal and state courts nationwide over its smoking cessation drug Chantix, according to a company filing with a federal regulator this week. The company says it is assuming a loss of $273 million for 2012 to settle those […]
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Philadelphia May Lose URL Pharma
The future looks dicey for the local operations of a decades-old Philadelphia drug company that succeeded in raising the price of a popular gout medicine by 100 times despite an outcry from sufferers of the painful affliction. URL Pharma, which won Food and Drug Administration approval in 2009 on a patented version of colchicine, a […]
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Less Spent By Pharma in 2012 to Promote Drugs
Source In 2012, more than $27 billion was spent by the pharmaceutical industry in the US to promote medicines, which amounted to an 8 percent drop from the previous year. Some things, however, stayed the same. The share of the top therapeutic classes by spending was largely unchanged from 2011, with cardiovascular drugs declining by […]
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FDA Goes After Pharma Facebook Likes
Which FDA District Offices Are The Best and Worst to Work With? Which Inspectors Are the Best and Worst for Your Audit? Find Out March 13! Source Last month, the FDA tagged a dietary supplement maker for a laundry list of infractions, but one item tucked away in a December 11 warning letter stands out. […]
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Greek Panic As Pharma Companies Stop Drug Shipments
Which FDA District Offices Are The Best and Worst to Work With? Which Inspectors Are the Best and Worst for Your Audit? Find Out March 13! Source The economic crisis in Europe is taking a serious turn in Greece, where a shortage of more than 200 medicines is being blamed on drugmakers that have halted […]
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FDA News Update for 3/6/13
Which FDA District Offices Are The Best and Worst to Work With? Which Inspectors Are the Best and Worst for Your Audit? Find Out March 13! Source 3/6 Specialty Drug Costs Have PBM’s Scratching Heads – PBM’s working on tactics to rein in wildly expensive costs including political pressure to push biosimilars Spending on […]
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Roche Provides More Access to Clinical Trial Data
Source In response to enormous criticism over its handling of Tamiflu clinical trial data, Roche announced a new plan to increase access to such information and its approach mimics steps begun recently by GlaxoSmithKline. Specifically, Roche will work with an “independent†group of “recognized experts†to evaluate and approve requests to access patient-level data and […]
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