March Monday Madness
Of course, I'm off the day all heck breaks loose on the beat and stocks are making big moves all over the place.
In the diabetes drug space, the FDA handed out two so-called "Complete Response Letters."
That's the relatively new agency term for what used to be known as "Approvable Letters." Either way, it's a euphemism for "delay."
One letter went to Lilly, Amylin and Alkermes for their diabetes shot with the proposed commercial name of Bydureon. It's a once-a-week version of LLY and AMLN's twice-a-day injectable Byetta. So, the name kinda makes sense by using part of Byetta, "dur" for longer duration and "eon" for who knows what. We'll see if the FDA signs off on the name. Investors and analysts seem to have more confidence the FDA, at least, will approve the drug and sooner rather than later.
The other CRL was sent to MannKind, which is waiting for the FDA OK of its inhalable insulin Afrezza. Most analysts seem to think the contents of the letter don't bode well for the product. But they won't get a better fix on that until MNKD holds its conference call, which oddly isn't happening until tomorrow.
And finally, in the device arena, there's Boston Scientific reportedly pulling its implantable cardio defibrillators off the market over a regulatory issue with the FDA. Analysts think St. Jude and Medtronic will benefit from that surprising setback.
When it rains it pours.
Speaking of which, boy, did I pick the right weekend to escape to L.A. Torrential rains back in the northeast, 65 degrees, sunny and gorgeous out west. Back in the office tomorrow, though. I'll be prepping for a live interview with Roche CEO Severin Schwan on Wednesday at 11a.m. ET ahead of his company's analyst meeting. And, yes, I'll be asking him if he wants to buy Roche's cancer drug partner OSI Pharma , which today told Astellas to take a hike and said it's looking for other interested parties.
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