FDA on Pace to Approve Only 18 NMEs

That’s good for business, right?
Pharmalot has the story.

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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 [...]

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 timed, 25 foot walk test, just under half of the patients showed improved walking speed vs. placebo. Acorda plans to submit an NDA in 2009.
This was an interesting endpoint. [...]

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 to their highest in more than six years. The Impella 2.5, also the world’s smallest heart pump, is approved in the United States for partial circulatory support in critical patients [...]

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 [...]

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 ingredient that was detected in a product you’ve never heard of.
This email was different.
Subject Line: Contaminated Nipple Cream
Body: FDA is warning nursing mothers not to buy or use [...]

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 [...]

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 technology (PEGylation), their entire published preclinical pipeline (i.e.; their RNA antagonist oncology portfolio) and $150m of funding from Enzon. Not a bad way to start a company, right?
Maybe I’m way off [...]

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 that range however, they remain important medical problems. CIC accounts for roughly 6 million related outpatient visits each year and just over a quarter million hospital admissions with constipation as [...]

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 [...]

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 clearance to manufacture Myozyme (alglucosidase alfa) to treat Pompe disease (a rare genetic disease that inhibits the breakdown of glycogen in muscles into glucose) at the 2000L scale as opposed to the 160L [...]

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 medicines could even touch the pain. The problem was, up until now (finally, after a two year delay), I had to open two bottles of medicine, remove a few pills [...]

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 [...]