Today’s Wall Street Journal (8-2-07) had a front-page piece entitled Burden of Proof: Cancer Drug Fails, So Maker Tries New Pitch. Geeta Anand of the Wall Street Journal wrote it. The story is about Garo Armen and the biotech company, Antigenics Inc., which he founded 12 years ago and at a cost of 300 million [...]
Yesterday, I traveled to the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) where they reviewed the application for approval of Satraplatin (see my prior posts). The committee voted 12-0 recommending that the FDA delay the approval until all of the final survival data from the SPARC trial becomes available. [...]
On May 15th I wrote about an application to the FDA for approval of a new treatment Orplatna, trade name of Satraplatin. This hearing, in front of the Oncologic Drugs Advisory Committee (ODAC) is scheduled for July 24 with the session to begin at 1 p.m. Open public comment is projected to begin at 3 [...]
Dendreon Corp. has received great news from the FDA about their pending application for the approval of Provenge. STILL TIME TO SIGN PATIENT PETITION TO FDA FOR PROSTATE CANCER TREATMENT APPROVAL and Provengenow news-- Click Here NEW YORK (Dow Jones)--Dendreon Corp. (DNDN) Thursday said the Food and Drug Administration would accept interim trial data to [...]
Several thousand people have added their names to the sign-on letter at www.malecare.com, in just the first week. With May 31 as our dead line, many more names will be added. Our prostate cancer community is showing its size and cohesion. As Lance Armstrong so brilliantly advocates, we are living strong. We've also received about [...]