I had hoped to have some good stuff posted for you this week, but between a bout of something nasty combined with travel, it didn’t happen. Oh well, it is summer and things (like the nation’s well-being as overseen by an inept Congress) tend to slip.
There was just bad karma in the air this week. My home phone and WiFi/Internet went out, my cable is off, I dropped and broke my cell phone – nothing is working right so why should I?
And as we have July 15 pass, the summer see saw seems to now begin its tip to the second half….
And here is a little bit of the interesting stuff I noted from this week between illness and travel:
- Seattle Genetics Gets Unanimous Thumbs Up from AdComm for ADCETRIS(TM) - Seattle Genetics announced that this week ODAC voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS(TM) (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT). In addition, ODAC voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The FDA is expected to act on the two Biologics License Applications (BLAs) for ADCETRIS by August 30, 2011 under the Prescription Drug User Fee Act (PDUFA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
- FDA Seeks Comment on Proposed Policy for Diagnostic Tests Used with Targeted Drug Therapies – The agency announced this week that it was issuing a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy. There is an accompanying video from the agency on diagnostic tests and personalized medicine. The FDA is seeking public input on the draft guidance for 60 days. Comments can be submitted online or in writing, though oddly the release did not contain a link for electronic commentary.
- Pfizer’s PfizerUK YouTube Channel Scores Another Good Vid – For the most part, pharma offerings on YouTube are uninspired. However the PfizerUK channel many months ago produced a fun video to promote men’s health called “Don’t Be a Wilbert” – which was featured here in a posting in December, 2010. I am happy to report there is now a sequel in this effort and it is featured here.