Monday, March 11, 2013

Titan Pharmaceuticals Schedules Conference Call

Titan Pharmaceuticals, Inc. today announced that it will host a live conference call at 8 a.m. PT / 11 a.m. ET on Monday, March 18, 2013. Titan will provide the Company's financial results as of December 31, 2012. The call will be hosted by Sunil Bhonsle, president, Katherine Glassman-Beebe, Ph.D., executive vice president and chief development officer, Brian Crowley, vice president of finance and Marc Rubin, M.D., executive chairman.This will probably be bad news for TTNP.I sold my shares today at $1.74.To much of a gamble to hold my shares best of luck everyone holding.

ZGNX Rejection coming

The Advisory Panel vote was an 11-2 AGAINST approval. The FDA will give a CRL for sure. The FDA is looking for products that have a delivery system that prevents abuse. They just had a special meeting on abuse of sustained release products and the consensus was that not enough was being done to prevent abuse. The decision to delay was made so they could formulate a CRL letter that is consistent with the findings of the meeting. If you are in this stock, you better get out before it goes back to 75 cents. I shorted another 5000 shares  at $1.95 today.

Wednesday, March 6, 2013

TTNP Big day less than 2 weeks

Titan Pharmaceuticals big day is coming 03/21/2013 advisory committee meeting.
The Company’s New Drug Application (NDA) for Probuphine® for the maintenance treatment of adult patients with opioid dependence.Keep an eye on this one can get a nice little pop over the next week.I still have my shares from $1.38.Looking to unload them over the next week and a half.Don't want to hold them,might end up like ZGNX.If the vote is positive this could be bad for Zogenix stock holders over the next couple of weeks.

GLTA

Monday, March 4, 2013

DEPO Denied

The FDA panel, in a 13-to-1 vote, overwhelmingly ruled against Depomed's drug, saying clinical data failed to show the product was effective. Then the panel, in a 12-to-2 vote, ruled the overall risk-benefit profile wasn't acceptable to support marketing of the product. The panel, which is made up of non-FDA medical experts, will vote on Hisamitsu's drug later Monday.

Looking for a quick short and a little bounce at the open

Saturday, March 2, 2013

March FDA events

                                  March FDA events

This is a list of biotech company's upcoming events that I will be keeping an eye on.

 DEPO   Advisory committee meeting on the 03/04/13
NRIFF  PDUFA date for Pennsail on 03/04/13
THRX   Advisory committee meeting on the 03/07/13
ANAC   Phase 3 result of Tavaborole out around the 3/12/13
TTNP   Advisory committee meeting on the 03/21/13
APPA   PDUFA date for APF530 on 3/27/13
 ZIOP  Phase 3 result of palifosfamide around the 03/29/13
ACRX  Phase 3 result of Sufentanil around the 03/31/13
ALIM  Will be resubmitting the NDA for lluvien around the 03/31/13
CYCC Phase 3 results for Sapacitabine around the 03/31/13
IGXT NDA filing for Rizatriptan on 03/31/13

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.