Teens Find It Easy to Use ‘Morning After’ Pill, Study States
Source: Pharmalot Three months ago, the US Department of Health & Human Services took the unprecedented step of overruling the FDA and thwarting a move to ease access to Plan B, which is also known as the morning after pill. The contraceptive is currently available only to women age 17 and older without a prescription, […]
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Nobilus Poland Plant Gets Import Ban After FDA Warning
Even as Congress considers giving the oft-criticized FDA inspection program more money, warning letters posted this week on the FDA website give some indication of the breadth of the agency’s responsibilities and just why it is in such need. They include warning letters to an API plant in Poland, a drug manufacturing plant in Mexico […]
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FDA Keeps Its Import Alert Intact on Polish API Manufacturer
Source: Pharmalot On its modest web site, Nobilus Ent brags that active pharmaceutical ingredients are offered at a good quality for a reasonable price and that its two facilities, which are based in Poland, meet good manufacturing practices. But not according to the FDA. The agency is keeping the supplier on an import alert for […]
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J&J Unit Shuts Down Face Book Page Due to Obscene Comments
Source: Pharmalot More than a year after launching its Psoriasis 360 page on Facebook, the Janssen UK unit of Johnson & Johnson is closing down due to a growing number of comments that had to be removed because specific drugs were mentioned or, in some cases, offensive language was used. The decision was posted on […]
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Huh? New Abbott Spinoff Named Abbvie?
Source: Pharmalot Six months ago, Abbott Laboratories decided to split into two publicly traded companies. One will focus on devices, diagnostics, nutritionals and, outside the US, branded generics. The other will be a so-called research-based pharma that will feature a portfolio of existing meds, such as Humira and Synthroid, along with a pipeline of some […]
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Pharma CEOs Concede That Pharma Model Is Broken
Source: Pharmalot As if we didn’t already know this, yes? Still, a new survey finds that 68 percent of pharma execs agree that Humpty Dumpty has fallen off the wall. To be specific, 44 percent agree that the pharma industry model is broken and 24 percent strongly agree with this statement. Another 22 percent are […]
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Novartis and Walgreens Join Up On Clinical Trials
Source: Pharmalot As pressures mount to boost profits and lower costs, drugmakers are, of course, looking for new ways to generate more prescriptions and improve patient adherence. So it is not surprising that Novartis would reach out to Walgreens, which is one of the largest pharmacy chains in the US, to discuss various efforts that […]
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Exaggerated Benefits of Antipsychotic Drugs Show in Trial Review
Source: Pharmalot Yet another instance of alleged publication bias has emerged. Four years ago, a review of unpublished studies submitted to the FDA by various drugmakers found many antidepressants had little or no effect on patients. How so? Selective reporting nearly doubled the apparent proportion of positive trials, exaggerating the benefits and, presumably, influencing patient […]
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Romania Fines Bayer $2 Million For Antitrust
Source: Pharmalot The Competition Council in Romania levied a total of nearly $16 million in fines on Bayer and one other drugmaker, Sintofarm, along with nine distributors for striking deals that prohibited exports. Although Bayer was fined roughly $2 million, the largest penalty is being paid by one of the distributors, MediPlus, which will pay […]
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FDA panel backs Glaxo drug for rare sarcoma cancer
A panel of cancer experts rejected an experimental Merck drug for a rare form of cancer on Tuesday while recommending approval of a GlaxoSmithKline treatment for the same disease. Neither drug appears to help patients live longer, but panelists said Glaxo’s Votrient helped delay tumor growth in the most vulnerable patients. The FDA panel reviewed […]
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