It was an interesting week in biotech with a couple of advisory committee meetings, a controversial Food and Drug Administration decision, and more. Here are your top entertaining and enlightening tweets from the week that was.
Aegerion Pharmaceuticals (NASDAQ:AEGR) was up 16% on Monday after the FDA issued a warning letter chastising CEO Marc Beer for making claims on CNBC that the company's cholesterol-lowering drug Juxtapid had benefits that hadn't been proven (yet).
These letters are the equivalent to a mom putting a kid on timeout. The company has to take corrective action to fix the problem, but there's no real penalty as long as it stops doing what the FDA is upset about. Investors made the right call to brush it off as immaterial to Aegerion's ability to sell Juxtapid.
@adamfeuerstein Is she sitting backwards to express her 180 she just did?— Colfax (@ColfaxCapital) November 15, 2013
The FDA threw a curve at Sarepta Therapeutics (NASDAQ:SRPT) this week when it told the biotech not to apply for accelerated approval for its Duchenne muscular dystrophy drug eteplirsen. I still think Sarepta has multibagger potential, but investors are going to have to wait a lot longer for the payoff.
Unfortunately, Janet Woodcock, the director of the Center for Drug Evaluation and Research, didn't say anything interesting about the change in plans when Rep. Eliot Engel (D-NY) asked her about the decision when she appeared before a congressional committee to talk about the implementation of the Safety and Innovation Act.
And, no, she wasn't sitting backwards.
Are we getting to the point where these panels just shouldn't have voting questions at all?— Andrew G. (@BioDueDiligence) November 13, 2013
The committee meeting reviewing Sanofi's (NYSE:SNY) multiple sclerosis drug Lemtrada was strange to say the least. When the FDA poses multiple voting questions, the later questions are often predicated on the vote of the early questions. For Sanofi's Lemtrada, the committee was asked if the clinical trials were adequate and well-controlled and were later asked about the safety and efficacy of the drug, which shouldn't much matter if the clinical trials weren't run properly.
The FDA says it considers the comments by the outside advisors as much as it does the actual vote, so why not just forgo the vote altogether. I know no one would miss the woefully ineffective machine that counts the votes.
And finally, a look forward to data coming out of the American Heart Association's annual meeting that begins on Saturday.
You have to wonder how much it cost Johnson & Johnson (NYSE:JNJ) and Bayer to get its advertisement for blood-clot preventer Xarelto on the hotel keys at AHA. You'll notice that the advertisement doesn't say what Xarelto is used for. By not including it, Johnson & Johnson and Bayer don't have to include the full side-effect warnings, which I imagine would be hard to fit on a hotel key.
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