Biotech Notebook: Vertex, Medicines Co.

"We have received no formal action from the FDA" on Cleviprex, says The Medicines Co. investor relations head Robyn Brown.

Brown adds that the company made a deliberate decision to keep quiet about the Cleviprex FDA review because it doesn't want investors to fixate on a specific FDA decision date.

Given the spate of tardy drug review decisions by the FDA these days -- Cardiome's (CRME Quote) Vernakalant springs immediately to mind -- keeping the pressure off a specific PDUFA date might not be a bad strategy. Then again, investors (and columnists) can do the math, so questions about Cleviprex's FDA outlook are going to be raised increasingly as the calendar slips into summer.

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With Boston baking under mid-90-degree temperatures, summer seems to have arrived a bit earlier than normal. Experienced biotech investors know this signals the start of the sector's off season. The medical conference calendar goes dark and investor interest in the sector wanes.

Don't forget about biotech entirely, however, because there are a decent number of events in the next few months that should move some stocks. At the top of my summer watch list is the Alzheimer's clinical trial data releases from Myriad Genetics (MYGN Quote) and Elan (ELN Quote) and Wyeth (WYE Quote), respectively. I'll have more to say on those two events later.

We could get word from MiddleBrook Pharmaceuticals (MBRK Quote) on a possible sale of the company, and Vanda Pharmaceuticals (VNDA Quote) is expecting an FDA approval decision on its schizophrenia drug iloperidone. (The decision will impact Titan Pharmaceuticals (TTP Quote), too.)

YM BioSciences (YMI Quote) should release results from its colon cancer trial for nimotumumab; while SuperGen (SUPG Quote) could received word on the outcome of its survival trial for Dacogen in patients with myelodysplastic syndrome.

Lastly, Introgen Therapeutics (INGN Quote) has promised to file its head-and-neck cancer drug Advexin with regulators here and in Europe by the end of June. This has been a stalled effort four years in the making, so we'll see if Introgen finally makes good on its word.