January 12th, 2012
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January
18 – CBRX FDA Briefing Documents released
19 – CTIC EU CHMP Pixantrone decision
20 – CBRX Ad-Comm
28 – ALKS, AMLN PDUFA for Bydureon
February
4 – ALXA PDUFA
7 – CTIC FDA Briefing Documents released
7 – ASTX FDA Briefing Documents released
7 – NGSX FDA Briefing Documents released
9 – CTIC Ad-Comm
9 – ASTX Ad-Comm
9 – NGSX Ad-Comm
17- CORT PDUFA
20 – VVUS Briefing Documents released
21 – CHTP FDA Briefing Documents released
22 – VVUS Ad-Comm
23 – CHTP Ad-Comm
26 – CBRX PDUFA
Other Possible Events
ONTY – (Interim Analysis)
ANTH – (Interim Analysis VISTA-16 trial)
VVUS – (EU Decision)
ARNA – (Announcement of an Ad-Comm is needed, without an Ad-Comm the FDA will not approve a weight loss drug. Therefore absence of an Ad-Comm is a good indicator of CRL).
THLD – (PH2 Data)
QCOR (Streetsweeper report)
MAPP – (Ad-Comm notice, company has yet to announce an Ad-Comm, Levadex is an inhalable)
January 10th, 2012
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Corcept (CORT): Mifepristone PDUFA Notes
This article will focus on Corcept’s PDUFA for Mifepristone for Cushing’s Syndrome. Cushing’s Syndrome is a rare hormonal disorder with no FDA approved therapy available to patients. It is a hormonal disorder caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol. » Read more: Corcept (CORT): Mifepristone PDUFA Notes
January 4th, 2012
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Arena Pharmaceuticals (ARNA) Conference Call Notes
So these are some quick takeaways from Arena’s conference call yesterday:
1) Let’s start this off with the way in which the resubmission to the FDA was disclosed to investors. The company stated that they had resubmitted their NDA to the FDA on 12/27/2011, yet waited and allowed their stock to trade on the market until 1/3/2012 without making this material information available to their investors. » Read more: Arena Pharmaceuticals (ARNA) Conference Call Notes
December 8th, 2011
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So I decided to make this a post about the greatest FDA reviewer statements in their review of the Alexza Pharmaceuticals‘ lead product formerly called AZ-004. FDA’s review found here, and of course, I’ll list the page numbers so you can verify them for yourself. » Read more: Alexza’s (ALXA) Briefing Documents: Greatest Hits
December 8th, 2011
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Antares Pharmaceutical Wins Anturol Approval
Right now attention is focused on two catalysts for Antares: Anturol’s PDUFA and BioSante’s Libigel efficacy data release which is due out sometime in early December.
» Read more: Antares Pharmaceutical (AIS) Wins Anturol Approval, But Is It Overvalued?
December 2nd, 2011
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Affymax Briefing Documents Prep
So I’m going to highlight some of the concerns/risks that I’m looking for in the Affymax Peginesatide Briefing Documents that are due to be released on Monday morning. I have previously reviewed the drug and I recommend reading that analysis before reading further because this article will be in bullet point format and not an overview of the entire NDA. » Read more: Affymax (AFFY) Briefing Documents Prep
November 23rd, 2011
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FDA has informed me that Transcept’s Intermezzo has been approved. I’ll be the first to admit I was wrong and eat crow on this one. Here is the FDA’s offical press release –> http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm281013.htm
November 22nd, 2011
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Transcept is facing their 3rd PDUFA for their lead product Intermezzo for Middle of the Night Awakenings on November 27, 2011. » Read more: Transcept (TSPT): PDUFA Analysis
November 9th, 2011
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Alimera Sciences (ALIM) Trading Guesstimates
My Opinion
As I outlined in an earlier article, I noted that I think Alimera faces higher odds of receiving a Complete Response Letter for two main reasons: One being that the company, from my perspective, has not adequately addressed the Risk/Benefit tradeoff and the other being that the company is currently conducting a Doctor Utilization study of their lead product Iluvien. » Read more: Alimera Sciences (ALIM): Share Price Target Trading Guesstimates
November 8th, 2011
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Alimera Sciences (ALIM) Iluvien PDUFA Analysis
Alimera Sciences faces a PDUFA on November 12, 2011 for their lead product Iluvien for diabetic macular edema (DME). Iluvien is inserted in the back of the patient’s eye to a placement site that takes advantage of the eye’s natural fluid dynamics to deliver the non-proprietary corticosteroid fluocinolone acetonide (FAc). » Read more: Alimera Sciences (ALIM) Iluvien PDUFA Analysis
November 2nd, 2011
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Amarin (AMRN): Biotech Patent Perspective
This morning it became apparent that Amarin had received a Non-Final Rejection for one of their patents of their lead product AMR101. » Read more: Amarin (AMRN): Biotech Patent Perspective
October 27th, 2011
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Pacira Pharmaceuticals (PCRX): Some Thoughts On Price Action
Ok, I thought about this over and over all day. And I think there are a couple of different scenarios that can play out with Pacira Pharmaceuticals tomorrow with different price reactions. So I’ll go through them. » Read more: Pacira Pharmaceuticals (PCRX): Some Thoughts On Price Action
October 26th, 2011
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Pacira Pharmaceuticals (PCRX): My Opinion on Approval
On October 28, 2011 the FDA will decide whether or not to approve Pacira’s lead product Exparel for postsurgical pain management. Exparel is essentially the combination of a 20 year old local anesthetic, bupivacaine, and their Depofoam technology (this is a liposome portion of Exparel). The general idea behind Exparel is that the bupivacaine is encapsulated in the DepoFoam technology and the Depfoam extends the duration of analgesia. » Read more: Pacira Pharmaceuticals (PCRX): My Opinion on Approval
October 24th, 2011
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Exelixis (EXEL):
This morning Exelixis announced top line results from an ongoing Phase 3 trial of their drug cabozantinib in patients with advanced medullary thyroid cancer (MTC), known as the EXAM trial. The trial met its primary endpoint of improving progression-free survival (PFS) compared with placebo and substantially exceeded the threshold of a 75% increase in PFS originally assumed when the trial was designed. » Read more: Daily Pharma Watch
October 20th, 2011
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