More FDA Oversight for Drug Compounders?
Source Over the past two years, compounded medications have figured in two highly controversial episodes. In one instance, Roche attempted to prevent ophthalmologists from using its older Avastin med for treating wet macular degeneration when its newer and more expensive Lucentis is the only approved treatment. The drugmaker has claimed that rejiggered vials of Avastin […]
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Cipla Medpro CEO Quits to Duck Hearing
Source Just as a disciplinary hearing was set to get under way to probe “serious,†but unspecified allegations that were disclosed two months ago, Cipla Medpro ceo Jerome Smith has resigned, iAfricareports. And analysts speculation his departure may pave the way for a takeover of one of South Africa’s best-known drugmakers, which sells a variety […]
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SEC Looks At Pfizer’s Domestic and Overseas Reporting
Source The US Securities and Exchange Commission is trying to solve an accounting riddle – how is that Pfizer was able to record big overseas profits but losses in the US when 40 perfcent of its sales are generated in foreign countries? Over the past few months, the agency and Pfizer have engaged in […]
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Sanofi Executive Transferred After Major Algerian Scandal
source Last June, an appeals court in Algeria upheld a $25 million fine against Sanofi and a one-year suspended prison sentence for Thierry Lefebvre, its general manager in the North African nation, for overcharging for drugs and active pharmaceutical ingredients. Now, Lefebvre is being replaced, although the drugmaker insists the change is part of a […]
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Ex-Glaxo Lawyer Discusses FDA Investigation of Wellbutrin
source Last year, the federal government lost a closely watched case in which a former GlaxoSmithKline lawyer had been indicted for obstructing an FDA investigation into whether the drugmaker illegally marketed its Wellbutrin SR antidepressant as a diet pill. The indictment initially signaled a rare effort by the feds to hold a pharma exec accountable […]
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Ex FDA Commissioner Slams J&J for Risperdal
In the latest setback to Johnson & Johnson and its seemingly futile attempts to defend its Risperdal marketing, the health care giant is attempting to prevent former FDA commish David Kessler from testifying in yet another case involving a teenage boy who claims the antipsychotic caused him to grow breasts. And J&J wants to keep […]
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FDA launches campaign to warn public about counterfeit drugs, other risks of online pharmacies
The Food and Drug Administration is warning U.S. consumers that the vast majority of Internet pharmacies are fraudulent and likely are selling counterfeit drugs that could harm them. The agency on Friday launched a national campaign, called BeSafeRx, to alert the public to the danger, amid evidence that more people are shopping for their medicine […]
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FDA warns Zimmer over manufacturing of hip devices
Zimmer Holdings Inc said it received a warning letter from the U.S. Food and Drug Administration citing problems with manufacturing and testing processes for artificial hip devices made at the company’s Ponce, Puerto Rico, plant. The warning letter, dated September 19, does not restrict production or shipment of the hip devices, called Trilogy Acetabular Systems, […]
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More jobs lost as BioInvent focuses on cancer
Sweden’s BioInvent International has unveiled further job cuts as part of its decision to specialise on oncology. In the summer, the number of full-time employees was reduced by 21 at the Lund-based firm to 68 staff following the failure of TB-402, a long-acting anticoagulant partnered with ThromboGenics, in a Phase IIb trial. Now another 20 […]
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Abbott CEO Says Gonzalez Resume Was Mistake
source In an effort to set the record straight, Abbott Laboratories ceo Miles White yesterday attempted to clarify countless reports and Internet discussions about the flap over the degrees that were listed in the bio for Richard Gonzalez, who is about to head the AbbVie spin off in January (pictured to the left). In […]
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