Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek’s own, and he does not in any way speak for his employer.

By Derek Lowe

Posts tagged with "Regulatory Affairs"

• Current Events

  Pharma and the Health Care Bill: Value For the Money?

  16 February, 2010

  I hesitate to open up the whole topic of health care reform again. (For the record, I think that the bills, in their current forms, are dead). But one thing that struck me was how early the pharma industry trade group PhRMA got involved in the negotiations, and the sort of deal that they struck. Read More

• Cardiovascular Disease

  Plavix vs. Effient

  19 November, 2009

  The InVivo Blog has a good article on a controversy in the blood-thinning market. Plavix (clopidogrel) has a very strong share of that, of course, but since Effient (prasugrel) was finally approved, Lilly and Dai-Ichii are looking to take as much of that market as they can. And one opening might be that not everyone… Read More

• Business and Markets

  In Which You Get to Hear the Phrase “Hatch-Waxman” Again

  2 November, 2009

  There’s a constant running battle in the drug industry between the two kinds of pharmaceutical companies: the ones who discover the drugs first, and the ones who sell the drugs cheaply after the patents have expired. It surprises me still how many people I run into (outside my work) who don’t make that distinction, or… Read More

• Current Events

  The Details of the Baucus Bill

  25 September, 2009

  Since we were discussing the Baucus health care proposal here the other day, I thought that people would appreciate a chance to read through the provisions of the bill before forming an opinion of it. Sorry! You can’t. It’s not online, and it won’t even be online by the time the Finance Committee is through… Read More

• Current Events

  Pay Them Now, Or Pay For It Later

  23 September, 2009

  Time for a brief comment on health care reform, now that Sen. Baucus has presented a bill to the Finance Committee (which, to be sure, I believe has already attracted over 500 proposed amendments). As is well known, the largest drug industry trade group, PhRMA, signed on to the whole idea of a large reform… Read More

• Cardiovascular Disease

  Statin Safety?

  22 September, 2009

  Senator Charles Grassley of Iowa has sent the FDA a letter asking if the agency has sufficiently considered adverse events from statin drugs. I’ve been unable to find the text of the letter, but here’s a summary at Business Week. (Grassley’s own list of press releases, like most other senators and representatives, is a long… Read More

• Business and Markets

  The Drug Business: A Turbulent Future?

  17 September, 2009

  One of this blog’s regular correspondents has just been attending a chemistry outsourcing conference (program here), and heard a very interesting talk from Stefan Loren of a Baltimore investment advisory firm, Westwicke Partners. Loren’s a product of the Sharpless lab, who went on to Abbott, then Wall Street (Legg Mason and into the hed… Read More

• Business and Markets

  A 2.3 Billion Dollar Attention-Getter

  3 September, 2009

  No sooner do I write another post about pharma marketing than Pfizer finds itself paying 3.2 2.3 billion dollars in fines for doing it improperly. 1.2 billion of that is a criminal penalty, and needless to say, they’ve set the current record. The issues were off-label promotion of Bexxtra, Geodon, Zyvox, and Lyrica, with the… Read More

• Regulatory Affairs

  REACH for the Sky!

  28 August, 2009

  I wrote years ago on this blog about REACH, the European program to (as the acronym has it) Register, Evaluate, Authorize and Restrict Chemical substances. (I’m not sure where that second R got off to in there). This is a massive effort to do a sort of catch-up for chemicals that were introduced before modern… Read More

• Diabetes and Obesity

  Obesity Shows Up in the Death Rate? Right?

  21 August, 2009

  Here’s an interesting post at Chemiotics (a new addition to the blogroll): Something is Wrong With the Model . . . The Center for Disease Control released new data for 2007 (based on 90% of all USA death certificiates) showing that mortality rates dropped again (by over 2%) to 760/100,000 population. It’s been dropping for… Read More