FDA Alert: United Therapeutics (UTHR) and Genentech (DNA)
On August 9 and 10, the Cardiovascular and Renal Drugs Advisory
Committee will meet to decide the fate of two drugs to treat Pulmonary Arterial
Hypertension (PAH).
FDA Alert: Aviron (AVIR)
An FDA advisory committee will review Aviron’s investigational influenza GÇ£fluGÇ¥ vaccine (Flumist) when it meets on July
26-27.
FDA Alert: Amylin Pharmaceuticals (AMLN)
On Thursday, July 26,
the Endocrinologic and Metabolic Drugs Advisory Committee will decide the fate
of Amylin Pharmaceuticals’ new drug Symlin.
FDA Decision Postmortem: Ortec International
Lessons past and present
FDA Alert: Ortec International (ORTC)
On Tuesday, July 17, the FDA will convene a meeting of the General and Plastic Surgery Devices Panel to decide the fate of Ortec International’s
July: A Biotech Trader’s Month
Along with the FDA, July offers several medical meetings that will
highlight some very high profile companies and provide an opportunity for
traders to be in on some stock movement
The FDA’s Helping Hand To Investors
On June 28, several companies filed New Drug Applications (NDAs) with the FDA for their lead drugs.
FDA Decision Postmortem: Genelabs
Could
investors have seen this negative decision coming? The company was banking on this breakthrough drug for future revenue and does not have a drug pipeline to fall back on
Medical Meeting Alert: Diabetes
When it comes to biotech, a
rising tide does lift all boats. I expect the positive news coming out of this meeting by next week
to buoy the biotech sector as a whole, since the entire sector tends to move
when specific companies present positive clinical data in growing markets.
FDA Decision Postmortem: Praecis
On
June 12, the FDA Advisory Committee on oncologic drugs rejected the
new drug application of a new treatment for advanced prostate cancer, a growing
market
FDA Decision Analysis: Orphan Medical
The committee voted 6 to 3 to verify Xyrem’s efficacy
New Frontier For Cancer Treatment
It is no coincidence that the
biotechnology indices have performed well over the last few months, particularly those companies involved
in cancer drug development.