Finally!

Acorda finally got what it's been looking for: an FDA nod of approval for its pill (Ampyra or Fampridine) to aid MS patients's ability to ambulate. I didn't think this was actually every going to happen as Acorda had to fight through one unsuccessful NDA submission and delays in the approval process. While the data are not overwhelming, it is in doubt that that pill can and does actually help some MS patients walk better...a significant benefit to this disease that can severely restrict ones ability to get around. You can expect Acorda's stock to reflect this approval in a big way, and as an added bonus for the company: a front page CNN.com article about the drug and the approval.

Here's the release from the FDA, courtesy of Fierce Biotech

Acorda's pipeline here


In other news it seems there is a potential cure for baldness. The only problem is that the public can't get it right now because of legal issues between the original developer (SkinMedica) and it's current developer (Histogen). It's hard to say who's right and who's wrong, but one thing is for sure...neither company will end up suffering as much as the men out there who hate their lack of hair. Somebody should really patch things up between those two companies so people can benefit from their collective work on this hair growth promoting product. Ridiculous.

BNet reports on the situation here


Last, but not least: Somaxon has resubmitted the NDA for its insomnia drug, Silenor. This drug has been rejected, not once but twice by the FDA. After meeting with agency a couple times, Somaxon thinks it has ironed out the problems and accumulated the data needed for an approval. Somaxon would clearly benefit from an approval, and stock prices have already risen substantially. Silenor itself is another example of an attempt at a sleep promoting drug that works without the residual sedation that plagues medications like Ambien. Unfortunately these drugs often don't work as well as Ambien...maybe Silenor will be different.

http://www.fiercebiotech.com/press-releases/somaxon-provides-update-new-drug-application-silenor-treatment-insomnia and Silenor itself