Can't keep a good Mann(Kind) down

Nevermind that the FDA said it will miss its self imposed Jan. 16th deadline for action on MannKind's inhaled insulin. Nevermind that the agency has yet to complete inspection of the company's manufacturing facility. MannKind remains optimistic that their product will clear that final hurdle and get good news within "days" of the completed facility inspection. In a world full of cautious optimism, MannKind's belief in their product is great, but how would they handle a negative FDA response to Afresa? I guess we'll find out one way or another within the next few weeks...

Reuters reports here

Finally, some good news for Biogen and the much beleaguered Tysabri. The company said reported that Tysabri's sales exceeded $1 billion for the first time ever in 2009, essentially elevating the biologic to "blockbuster" status (i guess you could call it the equivalent of going platinum). I think this speaks wonders for the drug because patients/physicians seem to believe pretty strongly in Tysabri in spite of the continuous presence of PML. Unless the incidence of PML or other problems spikes unexpectedly, I would plan on Tysabri being around for the long haul.

See more from Bloomberg on Biogen's Tysabri announcement...

Must be nice if you market a top 15 drug with no legit competition on the horizon. That seems to be the case with Advair, at least according to GSK. Several potential asthma drugs have gotten the chop lately by the FDA and GSK does not think that any generics will rise to challenge Advair when its patent expires in 2011. Pretty good news I'd say, and not something that you hear everyday with the surge in generics lately.

Fierce Pharma talks about it here