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Posts tagged with "Regulatory Affairs"

  • Regulatory Affairs

    Merry Christmas From the FDA

    I see that the FDA is in the holiday spirit – they’ve told Ariad that they can bring Iclusig back to the market in the US, subject to restrictions, and Amarin, who have been trying, quite unsuccessfully, to get approval for wide use of a fish-oil-pill, have at least gotten a stay of execution for… Read More
  • Regulatory Affairs

    23 And Me And the FDA

    As everyone will have heard the personal-genomics company 23 and Me was told by the FDA to immediately stop selling their product, a direct-to-consumer DNA sequence readout. Reaction to this has been all over the map. I’ll pick a couple of the viewpoints to give you the idea. From one direction, here’s Matthew Herper’s article… Read More
  • Clinical Trials

    Sarepta’s Approval Woes

    I briefly mentioned Sarepta and etiplirsen, their proposed therapy for Duchenne muscular dystrophy (DMD) in September. In that post, I made reference to the “delirious fun of investing in biotech”. Well, the company recently got some regulatory news that illustrates that point even more clearly. The FDA told Sarepta that it would not ge… Read More
  • Business and Markets

    The Other Shoe Drops at Ariad

    Ever since Iclusig (ponatinib) (note: fixed that name as an update) ran into trouble with blood-cloting side effects, Ariad has had a huge uncertain cloud blocking out its sunlight. Now that the FDA has told them to take the drug off the market completely, it was clear what was going to happen. Happen it has: Read More
  • Clinical Trials

    The FDA: Too Loose, Or Appropriately Brave?

    The topic of the various “accelerated review” options at the FDA has come up here before. Last month JAMA ran an opinion piece suggesting that the agency has gone too far. (Here‘s the Pharmalot take on the article). This, of course, is the bind the agency is always in. Similar to the narrow window with… Read More
  • Drug Prices

    Catalyst Pharmaceuticals And Their Business Plan

    The orphan-drug model is a popular one in the biopharma business these days. But like every other style of business, it has something-for-nothing artists waiting around it. Take a look at this article by Adam Feuerstein on Catalyst Pharmaceuticals, and see what category you think they belong in. They’re developing a compound called Firdapse f… Read More
  • Cancer

    Ariad (And Its Drug) In Trouble

    Ariad’s Inclusig (ponatimib) is in even more trouble than it looked like, and that was already a lot. The company announced earlier this morning that its Phase III trial comparing the drug to Gleevec (imatinib) is not just on hold – it’s been stopped, and patients are being taken off the drug. That can’t be… Read More
  • Regulatory Affairs

    Ariad’s Ponatinib Runs Into Big Trouble

    Just a note, in case any investors didn’t realize it: no, drugs (and a drug companies) are not out of the woods after a compound has been approved and is on the market. Take a look at what’s happening to Ariad and their BCR-ABL compound Iclusig (ponatinib). This is used to treat patients that have… Read More
  • Business and Markets

    Sugammadex’s Problems: Is the Merck/Schering-Plough Deal the Worst?

    That didn’t take long. Just a few days after Roger Perlmutter at Merck had praised the team that developed Bridon (sugammadex), the FDA turned it down for the second time. The FDA seems to be worried about hypersensitivity reactions to the drug – that was the grounds on which they rejected it in 2008. Merck… Read More
  • Business and Markets

    Value For the Money

    BioCentury always does a big issue for the fall, entitled “Back to School”. They often use this as a state-of-biopharma platform, going into depth on what they see as the biggest issues that need to be addressed. This year, the September 2 issue, they’re telling people (and not for the first time!) to get braced… Read More