One small step for Mannkind?

The other day I mentioned the sharks circling, waiting on a decision from the FDA on Mannkind's inhaled insulin. Well, now it seems they'll be waiting around a little bit longer: the Agency said that it would miss its own January 16th deadline for a decision on the hotly debated medication, Afresa. However the delay here is not due to more data review, safety reports or things like that; rather the FDA says that it has not yet completed a thorough inspection of Mannkind's Afresa manufacturing facility. Analysts feel that in spite of this, an approval is waiting in the wings...so don't jump off board quite yet. Clearing this final regulatory hurdle will be huge news for Mannkind as well as insulin users across the US.

Pharmalot cogitates about the topic here....

Just so you don't forget that Vivus is not a one trick pony, the company released more information on their new ED treatment and the drug, Avanafil, continues to impress. The Phase 3 results were very impressive, showing significance compared to placebo at all doses being examined. While Vivus is entering a tough market with several ED meds already eating up market share, perhaps the quick response time (15 minutes) of men after taking the drug will encourage some changeovers. Keep Vivus in mind as they continue to impress...

Vivus press release can be found here, courtesy of Fierce Biotech

Targacept was busy making headlines over the second half of 2009 with its strong results from its new anti-depressant. As was mentioned in the fall, Astra-Zeneca felt good enough about the results to enter in a marketing/development agreement with the NC based biotech firm. Targacept has managed to secure its first big payment from Astra-Zeneca as part of this agreement ($200 million), so look for them to keep up the good work and continue to bring in the money. The company's stock has risen significantly over the past year...expect that trend to continue at least until phase 3 trials are completed in the near future.

And here's Targacept's press release, again from Fierce Biotech

Finally, some good news for Sanofi: a new Dengue fever vaccine being developed by the French company generated sufficient protection in all 66 adults receiving the vaccine in a small study. Just like the Malaria vaccine being examined by GSK, successful development of a Dengue fever jab will certainly have far reaching financial benefits to the manufacturer. The only question is (if the medication is effective) how much will it cost to those who are at risk of getting sick (think people in Africa)?

Read all about it from Bloomberg