Things categorized as 'FDA/Regulatory'
Pfizer-Wyeth
Image via Wikipedia In my last post, I gave five reason for Pfizer not to buy Wyeth and said I would be astonished ...
Drug Development: From Discovery to NDA
Introduction The time it takes from starting a program to selling a product can vary but is usually estimated to be around 10 years and ...
Fampridine Results Send Acorda Up +20%
Acorda Therapeutics announced positive results from its second Phase 3 clinical trial of Fampridine-SR on walking ability in people with multiple sclerosis (MS). In a ...
I Heart Abiomed
Heart pump maker, Abiomed, indicated that the FDA has approved the sale of its heart pump, Impella 2.5, driving its shares up about 24 percent ...
FDA Likes Promacta
A few days ago, I scratched my head in amusement over GSK / Ligand's decision to submit and NDA based on non-statistically significant results ...
Best Email Title Ever From FDA: Contaminated Nipple Cream
I get these automated emails from the FDA about product recalls. They are all usually pretty benign. They most often entail some undeclared ...
GSK submits non-statistically significant NDA for Promacta
An FDA reviewer said that Promacta, an experimental platelet-boosting drug seeking an indication for acute treatment of chronic idiopathic thrombocytopenia purpura from GSK, did ...
Icahn Steals The Future of Enzon Pharmaceuticals
Enzon Pharmaceuticals, on the reported urging of uber-investor Carl Icahn, will spin off a NewCo along with the majority of the company's core ...
Sucampo and Takeda’s Amitiza Approved for IBS-c
On a disease sexiness scale from 0-100, chronic idiopathic constipation (CIC) and irritable bowel syndrome (IBS-c) are close to rounding out the bottom of ...
Biotech/Pharma Competitive Intelligence
Introduction A significant chunk of my job in business development entails competitive intelligence and I've found the lack of biotech/pharmaceutical specific guide in this area a ...
Blow to Biogenerics: Genzyme Can’t Scale Myozyme
(From The Boston Globe via PharmaLot) The FDA set an extremely high bar yesterday for biosimilars when it ruled Genzyme could not get ...
Treximet… Finally!
I've been having migraines lately, well for the last few years. Terrible migraines. Migraines so debilitating only a combination of acutely acting ...
PDUFA Dates and Black Box Warnings
Like the FDA needs more bad press. The beleaguered drug watchdog has taken hits aplenty over the last few years for more reason that ...