Thursday, February 28, 2013

ANAC phase 3 results

Anacor Pharmaceuticals (NASDAQ:ANAC) today announced positive preliminary results from the second of two Phase 3 trials of tavaborole (known as Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States. Results from the first Phase 3 trial (known as Study 301) were announced on January 29, 2013. In both studies, tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints.

THRX Advisory Commitee Meeting 03/07/2013


THRXMarch 7, 20138:00 a.m. to 5:00 p.m.
 
FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
Agenda
The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.



Wednesday, February 27, 2013

DEPO Advisory Committee Meeting March 4, 2013

Depomed Announces Serada® NDA Acceptance and FDA Advisory Committee Meeting
MENLO PARK, Calif., Oct. 15, 2012 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO) today announced that its New Drug Application (NDA) for Serada® has been accepted for filing by the U.S. Food and Drug Administration (FDA).  In addition, the FDA has informed the company that the FDA's Reproductive Health Drugs Advisory Committee will discuss the Serada NDA at an Advisory Committee meeting tentatively scheduled for March 4, 2013.
The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013.  The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review.  The PDUFA date is the goal date for the FDA to complete its review of the NDA.

Stocks to Watch - 2/28/13

Zogenix, Inc. (ZGNX)
Uni-Pixel, Inc. (UNXL)
Guidewire Software, Inc. (GWRE)
Optimer Pharmaceuticals, Inc. (OPTR)
GeoGlobal Resources Inc. (GGR)
Meru Networks, Inc. (MERU)
StarTek, Inc. (SRT)
MAKO Surgical Corp. (MAKO)
U.S. Silica Holdings, Inc. (SLCA)
Dollar Tree, Inc. (DLTR)
FreeSeas Inc. (FREE)
Endeavour International Corporation (END)
Adventrx Pharmaceuticals, Inc. (ANX)

ZGNX FDA update

Zogenix reported Tuesday that the Food and Drug Administration would take longer than expected to review its drug Zohydro, a long-acting version of the painkiller hydrocodone. The FDA did not provide an explanation for the delay but indicated it "would likely be brief and may last only several weeks." Zogenix said the company has not been asked to submit any additional information.

Tuesday, February 26, 2013

Up Coming March PDUFA dates

ZGNX  03/01/13
NRIFF 03/04/13
APPA  03/27/13
BIIB  03/28/13
SLXP  03/30/13
UTHR 03/31/13

What do you think about these stocks?Buy Sell or Short

ZGNX

Zogenix (ZGNX) You'll want to mark March 1st on your calendar.That is zogenix pdufa date.That's the day the U.S. Food and Drug Administration is going to be passing down a decision in the company's Zohydro ER drug.The drug is just another version of hydrocone but in a extended release format.Which is good for stopping the abuse of pain killers.But the bad news is, the advisory panel that makes a recommendation to the FDA regarding new drug requests has recommended - by a margin of 11 to 2 - that the agency NOT approve Zohydro ER.This is why I have taken a short position in ZGNX.I will probably cover half  of my shares before mar 1 just to be on the safe side.And hold my free shares through the decision on mar 1.