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"

• Business and Markets

  Intermune’s Rise

  11 March, 2010

  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

• Autism

  Vaccines in the Court

  10 March, 2010

  The Supreme Court has agreed to hear a vaccine-liability case, in an attempt to untangle conflicting lower court rulings. This all turns on the 1986 act that shields manufacturers from liability suits and a followup law that establishes a separate compensation system for injuries. A Georgia Supreme Court ruling has recently held that such suits… Read More

• Biological News

  The Plasmid Committee Will See You Now

  2 March, 2010

  From Nature comes word of a brainlessly restrictive new law that’s about to pass in Turkey. The country started out trying to get in line with EU regulations on genetically-modified crops, and ended up with a bill that forbids anyone to modify the DNA of any organism at all – well, unless you submit the… Read More

• Cancer

  HER2 Confusion

  26 February, 2010

  For years now, drug companies and journalists have been touted the new era of personalized medicine. This is one of those things that always seems to be arriving, but is taking its time getting here. The industry has sunk a huge pile of money into biomarker research, and it’s safe to say that it hasn’t… Read More

• Diabetes and Obesity

  Avandia: Off the Market or Not?

  22 February, 2010

  The Senate report that leaked on Avandia (rosiglitazone) over the weekend has made plenty of headlines. It quotes an internal FDA report that recommends flatly that the drug be removed from the market, since its beneficial effects can be achieved by use of the competing PPAR drug Actos (pioglitazone), which doesn’t seem to have the… Read More

• 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