FDA Scientists Say Politics and Industry Sway Regulatory Decisions
Source With all the talk of reforming the FDA – speeding approvals, in particular – a new survey finds that most agency scientists believe political and corporate influence have sizeable weight on final regulatory decisions. And more than a quarter of agency scientists feel they are unable to openly express concerns about their “mission-driven†work […]
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FDA panel says pain drug trials should continue
The advisers to the U.S. Food and Drug Administration voted 21-0 that the agency should lift its hold on clinical trials of the drugs, from the class of anti-nerve growth factors. The FDA is not required to follow panel recommendations, though it often does, and will make a final decision later. The FDA halted almost […]
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AstraZeneca sues FDA over generic Seroquel
AstraZeneca said on Tuesday it was suing the Food and Administration after the U.S. regulator refused to delay the market entry later this month of generic versions of top-selling antipsychotic Seroquel. The drugmaker is seeking an injunction barring the FDA from granting final marketing approval of generic forms of the drug, whose chemical name is […]
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FDA Slaps Warning on Gulf Pharma
FDA has raised serious concerns about the manufacturing and data security processes at a plant in the United Arab Emirates operated by Gulf Pharmaceutical Industries. In a warning letter issued Feb. 23 and posted on the FDA website today, the agency said the company had been predating “Manufacturing Document Compliance Declaration forms.” Investigators also noted […]
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FDA Considers OTC Drug Switches
FDA is considering a range of measures to improve access to medicines, including making more drugs used for common, under-treated conditions – such as diabetes, asthma, migraine and high cholesterol – available over-the-counter (OTC). Under the proposals, pharmacists would be able to supply patients with “OTC-plus” products switched from prescription-only status following a discussion, or […]
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Widow Says That Genzyme Drug Shortage Killed Her Husband
Source: Pharmalot An Idaho woman has filed a lawsuit against Genzyme, charging that a long-standing shortage of its Fabrazyme treatment for Fabry disease led to the death of her husband two years ago. And he would still be alive, she claims, if the biotech had not experienced severe and persistent quality control problems that led […]
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Takeda Allegedly Hid Adverse Events, Whistleblower Says
Source: Pharmalot Takeda Pharmaceuticals may wish that Helen Ge was never hired as a consultant. She has now filed two whistleblower lawsuits alleging the drugmaker knowingly hid adverse events about various drugs. One lawsuit involved the Uloric gout treatment, which we recently reported (read here). Yet another concerns the Actos diabetes drug and a failure […]
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Whoa – India Grants 1st Compulsary License
Source: Pharmalot In a landmark ruling, India’s Patent Office has for the first time granted a generic drugmaker a compulsory license to make a copycat version of a patented medicine. The license was awarded to Natco, which can now make a generic of a Bayer kidney and liver cancer medication called Nexavar, although only for […]
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More on J&J, Synthes Warning Letter
Source: Pharmalot No acquisition comes without its warts. Consider Synthes. Last year, Johnson & Johnson agreed to pay $21.3 billion for a line of hip screws, surgical tools and other devices for treating spinal and soft-tissue injuries. The deal was lauded on Wall Street for allowing J&J to shore up one of three strategic legs […]
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More Paula Deen Headaches for Novo Nordisk – ‘N Word’ Alleged
Source: Pharmalot For the past month, the Novo Nordisk team may have thought the Paula Deen controversy was finally behind them. Their hope? That the public was on its way to forgetting her failure to acknowledge she has diabetes, even while cooking unhealty dishes on her Food Network show right up until the time she […]
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