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Posts tagged with "Regulatory Affairs"

  • Business and Markets

    Flex Pharmaceuticals Is Testing What?

    Flex Pharmaceuticals went public the other day, another in the string of IPOs in the biopharma world. This is also another Christopher Westphal company – he was a founder of Sirtris, about which much ink and many pixels (here and elsewhere) have been shed, and more recently founded Verastem (who also went public with alacrity). Read More
  • Regulatory Affairs

    India’s GVK Accused of Systematic Fraud

    This does not look good at all. The European Medicines Agency (EMA) has accused the large Indian generic company (and outsourcing contractor) GVK of widespread systematic fraud. According to this press release, the agency investigated about 1000 generic formulations of various drugs from GVK, and found that 300 of them had enough data (from other… Read More
  • Business and Markets

    Elizabeth Warren’s “Pharma Swear Jar” Idea

    Elizabeth Warren has come out with a proposal for what she’s calling a “pharmaceutical swear jar”. Once a drug company had been fined, this bill would earmark a percentage of their profits over a multiyear period for use in NIH funding. Like many of Warren’s ideas, this one has a lot of populist appeal – Read More
  • Business and Markets

    Actavis and Namenda

    John LaMattina has a column at Forbes about the situation with Actavis and their Alzheimer’s drug, Namenda (memantine). That situation is not a pretty one: the company has an extended-release form of the drug coming on, which they believe will be more convenient to dose. And that’s fine – except that part of their strategy… Read More
  • Business and Markets

    Puma and Neratinib Take Longer Than Expected

    When I last wrote about Puma Biotechnology and their irreversible kinase inhibitor neratinib, things were going great. The company had reported good Phase III data, taking investors by surprise, and the stock had shot up. An FDA filing was planned for just after the first of the year, and the future was bright. The story… Read More
  • Business and Markets

    AstraZeneca: How Many Approvals, Again?

    So AstraZeneca says that they’re expecting “8 to 10 ” approvals in 2015-2016. Has anyone ever done that? Even close? I take it that this whole press release is there to pump up investors and keep Pfizer from coming back and making another bid for them, but although the company does have a lot of… Read More
  • Drug Prices

    Catalyst Pharmaceuticals and Their Disgusting Business Strategy

    OK, this seems to be a new business model, damn it all. I wrote here recently about the huge price increase of Thiola (tiopronin) by a small company called Retrophin. Now, as I wrote about here last year, another small company called Catalyst Pharmaceuticals is preparing to jack up the price of Firdapse (3,4-diaminopyridine) for… Read More
  • Drug Industry History

    The Early FDA

    Here’s a short video history of the FDA, courtesy of BioCentury TV. The early days, especially Harvey Wiley and the “Poison Squad”, are truly wild and alarming by today’s standards. But then, the products that were on the market back then were pretty alarming, too. . . Read More
  • Clinical Trials

    Drug Repurposing

    A reader has sent along the question: “Have any repurposed drugs actually been approved for their new indication?” And initially, I thought, confidently but rather blankly, “Well, certainly, there’s. . . and. . .hmm”, but then the biggest example hit me: thalidomide. It was, infamously, a sedative and remedy for mornin… Read More
  • Cancer

    Incomprehensible Drug Prices? Think Again.

    There’s a post by Peter Bach, of the Center for Health Policy and Outcomes, that’s been getting a lot of attention the last few days. It’s called “Unpronounceable Drugs, Incomprehensible Prices”, and you know what it says. No, really, you do, even if you haven’t seen it. Too high, unconscionable, market can’… Read More