May has begun and it is time to see if the April showers thing pays off. And April went out like a lion. Who would have suspected just last Friday that a new pathogen would emerge and achieve pandemic status within a week? Suddenly the CDC has videos out on use of respirators, there are guidances for treating flu under all sorts of circumstances and with all types of patients. And if you sit back and take stock of the activity within a week, whether or not you are impressed by the threat of the pandemic, you have to admit that it looks like public health authorities for the most part, if not public officials, really have their act together in informing the public and unrolling their plan and getting out a LOT of information within the span of a short week. (Remember the communications train wreck around anthrax?)
- Northfield Labs Gets Complete Response Letter for PolyHeme – The FDA sent Northfield a CRL for its blood substitute investigational product. The letter cited both safety and efficacy concerns. With regard to the latter, the primary endpoint was not achieved in the pivotal trial- being another piece of evidence that no matter what the merits of the product – or how close it was to meeting the endpoint, if a primary endpoint is missed, it really narrows the chances of a product approval. The company is considering next steps.
- Prostate Cancer Treatment Developments – News came from two companies on the prostate cancer treatment front – one with a lot of drama, the other a bit more quietly. Dendreon announced this week the much anticipated results from its IMPACT trial which meant to look at the efficacy of its investigational prostate cancer vaccine Provenge, which previously received a CRL from the FDA. The announcement contained results that Provenge provided a 4.1 month survival benefit to prostate cancer patients over placebo. And Ferring Pharmaceuticals announced that they were beginning a Phase IIIb trial on Degarelix, a new injectible FDA approved gonadotropin-releasing hormone receptor antagonist to investigate its use in patients with advanced prostate cancer.
- Doctors Just as Or More Comfortable with e-Promotion Compared to Drug Sales Reps – An interesting study was reported by MM&M this week that revealed that 73% of doctors stated that e-promotions by drug companies are equal or superior to interactions with drug reps. A lot of people will take this news in different ways, but it is nonetheless, very interesting.
That's it for me this week. The events on the public health front have had me hopping. Have a good weekend everyone and be well. And if you are interested, here is a blow by blow chronology of the events as they unfolded this week related to the flu. Someone needs to put this in a widget.