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Posts tagged with "Regulatory Affairs"

  • Drug Development

    Flibanserin: Not a “Female Viagra” At All

    I haven’t commented on the controversy over Boehringer Ingleheim’s drug for female libido, flibanserin. An FDA advisory panel voted it down on Friday, and it wasn’t close: 10-1 against whether the drug showed efficacy, and unanimously against its side effect profile. I really don’t see how the drug is going to make it back f… Read More
  • Blog Housekeeping

    Nativis: In Which the Distant Footfalls of Lawyers Can Be Heard

    I’ve received a letter from John Kingma, the Chief Financial Officer of Nativis. I reproduce it below word-for-word (Here’s the PDF of the original, in case anyone would like to check): Dear Dr. Lowe, The scientific nature of your blog seems to have taken a turn for the worse with the negative personal attacks on… Read More
  • Cancer

    Eribulin Gets Reviewed, Finally

    So it looks like the FDA is giving reviewing Eisai’s oncology drug Eribulin (E7389) a priority review. The company had hoped to get it reviewed three years ago, but the FDA told them to get back into the clinic and collect more data. The compound is being reviewed for advanced breast cancer, and the earlier… Read More
  • Regulatory Affairs

    Regulatory Approvals in the US versus Europe

    I was looking at the list the other day of the 2009 drug approvals from the FDA. Here’s a breakdown from Nature Reviews Drug Discovery – 25 total, 16 small molecules and 9 biologics. And here, from the same journal, is a look at approvals in Europe. There were 29 – but the weird thing… Read More
  • Cancer

    Environmental Cancer?

    I find the President’s Cancer Panel report -at least, the general tone of it – hard to believe. Most of the headlines yesterday focused on the “grievous harm”, “bombarding”, and “grossly underestimated” statements, and suggested that there was an epidemic of environmentally-caused cancer. Since most a… Read More
  • Business and Markets

    Intermune: Right Back Down Again

    Back in March, Intermune’s stock saw a sudden jump on news that an FDA advisory committee treated their drug pirfenidone more positively than expected. But the agency is in no way committed to following these recommendations, and yesterday they turned down the drug, sending Intermune stock right back down into the basement again. Pirfenidone… Read More
  • Business and Markets

    Treatment INDs – For Any Generex Fans Out There

    Adam Feuerstein schools the Generex folks on what a “Treatment IND” really means, quoting chapter and verse from the FDA. The company’s fans have made much of that designation for its flagship buccal insulin product. As has the company’s CEO – but that link shows her making statements at investor conferences which are… Read More
  • Business and Markets

    Novartis, Roche Threaten To Leave the UK

    Now, here’s some hardball negotiating: Roche and Novartis, fighting with the UK government over drug pricing and regulations on clinical trials, are threatening to pull their R&D out of the country. The Swiss drug companies made their threats known in personal meetings with a government minister, according to Whitehall documents seen by… Read More
  • Biological News

    Garage Biotech

    Freeman Dyson has written about his belief that molecular biology is becoming a field where even basement tinkerers can accomplish things. Whether we’re ready for it or not, biohacking is on its way. The number of tools available (and the amount of surplus equipment that can be bought) have him imagining a “garage biotech” future… Read More
  • Business and Markets

    Intermune’s Rise

    If you want to know why people continue to speculate in biotech stocks, just take a look at the stairsteppy last few days of trading in Intermune (ITMN). Last Thursday it was at $15; now it’s at $38. And all you have to do to cash in on these moves is read the FDA’s mind! Read More