FDA bans Oridion imports, share prices dive 40%
The FDA banned Oridion Systems Ltd. (PINK:ORDNF) from importing any medical devices into the U.S., after the Israeli med-tech maker failed to fix violations at its Jerusalem manufacturing facility. Shares of Oridion fell 39% on news of the ban, from $11.00 to $6.65 at market opening Dec. 27. Because of the federal watchdog agency’s import […]
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French implants firm was criticised by US inspectors in 2000
American health officials warned the manufacturer at the centre of the breast implant scare that its products were “adulterated” and substandard 11 years ago, it has emerged. Investigators from the Food and Drug Administration wrote to the company in 2000 after inspecting its plant in the south of France. The development triggered questions over why […]
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Ion Labs Advised of GMP Violations
FDA recently sent a warning letter to Clearwater, Fl.-based Ion Labs due to failure to respond sufficiently to a prior 483 observation report given to the company after FDA inspected its facility. Among the key deficiencies noted in the report and letter are problems with the way the company reprocessed materials and failed to meet […]
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FDA Notes Lack of Novartis Exec Response in 3-Site Warning
Novartis CEO Joe Jimenez was on the receiving end of a particularly pointed FDA warning letter last month concerning generics unit Sandoz, and the letter made its way to the agency’s website Tuesday. Of note, the letter mentions the FDA’s concern about the company’s response to cited manufacturing violations, several of which are repeats. “Corporate […]
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H&P/Triad, Under Decree, Will Recondition Seized Wipes
The FDA has OK’d a plan by H&P Industries/Triad Group for the disposition of $6 million in products, mostly sterile wipes and alcohol swabs, impounded by U.S. marshals in April. The plan approval is an early step in the consent decree journey of the corporate kin and three named individuals, presumably brothers David and Eric […]
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Should The FDA Be An Independent Agency?
The outrage and hand-wringing continues over the unprecedented decision last week by US Human & Health Services Secretary Kathleen Sebelius to overrule the FDA and thwart a move to ease access to the Plan B pill, which is also known as the morning after pill. The move has generated intense debate that the White House […]
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Future For Novartis Hypertension Drug Is Bleak
There is an old saying that it is a short drop from the penthouse to the pavement. Consider Tekturna, a high-blood pressure drug that Novartis was hoping to transform into a blockbuster. Known as Rasilez in Europe, the pill was launched four years ago and faces stiff competition from older meds, some of which are […]
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Ranbaxy Pays $500M For Manufacturing Problems
And so, the other shoe has dropped. When the FDA granted last-minute approval on November 30 for Ranbaxy Laboratories to sell a generic version of the Lipitor cholesterol pill, there was no mention of a settlement for serious manufacturing problems that sidelined key plants run by the Indian drugmaker (read here). Now, though, a deal […]
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Riding High: Novartis And The Tekturna Chopper
By now, you may have heard that the Tekturna blood pressure pill that Novartis was hoping to transform into a blockbuster has a bleak future. Launched four years ago and facing stiff competition from older meds, including generics, the pill was being tested in high-risk patients in hopes of greatly expanding its market and ringing […]
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The Op-Ed: Concubinage Is Not What It Used To Be
Looking for ways out of their difficulties, some drugmakers have been turning to the automotive industry for advice on restructuring, vertical integration, product development time and the supply chain. But is this a wise move? To consider the question, we asked Daniel Hoffman, who is president of the Pharmaceutical Business Research Associates consulting firm and […]
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