fda
FDA on Pace to Approve Only 18 NMEs
That’s good for business, right?
Pharmalot has the story.
AutoGenomics Files for IPO
Mmmmm. I love a hot IPO market.
I especially love an integrated diagnostic testing systems company.
AutoGenomics announced it has filed an S-1 with the SEC. The price and number of shares have not yet been determined.
The company is based in Carlsbad and according to the S-1, has developed the first automated, microarray based multiplexing diagnostic [...]
Shire Ponies Up For Jerini
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Shire and its well known acquisition strategy are at it again, this time buying Berlin-based, Jerini for $521.2M (a 71% premium).
The rationale for the deal was the addition of Firazyr, an orphan drug treatment for hereditary angioedema (HAE), which received a not approvable letter from the FDA in April but has an EU [...]
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 the total cost associated with bringing a drug to market is widely cited to be at least $850 million. These numbers outline high stakes and whether you are an [...]
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 for their thrombocytopenia drug, Promacta.
Well, the scientific advisory committee (after lambasting the drug on Wednesday) unanimously voted in favor of the drug today.
Sometimes, I’m pretty sure I’ll never understand the regulatory [...]
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 not help control bleeding any better than a placebo. The reviewer wrote:
“The data provided in this NDA (new drug application) do not demonstrate statistically significant, robust … treatment effect in decreasing [...]
Elixir Hoping to Cash In On Sirtuins Too After GSK / Sirtris Deal
For the first time in almost 10 months, and not surprisingly, coming on the heels of the GSK / Sirtris buyout that occurred last week, Elixir Pharmaceuticals has announced that they have been granted a patent for a class of SIRT2 regulators. I came down as pretty negative on the Sirtris deal in [...]
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 bit distressing. In that vein, I’ve tried to compile a guide / list of services and hacks I currently use to keep up on the industry in general and [...]
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 can
be counted. The etiology of which, stem mostly from the lack of
sufficient funding from congress and an increasing workload. A study
published today in the NEJM illustrates what happens when [...]
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