- The days are truly shorter now.
- For the superstitious amongst us, it is an auspicious day ending this relatively quiet week. This morning it was so cold, one could see one’s breath upon exhaling, but the frost was not yet on the pumpkin.
- For a few, Friday the 13th may have started Monday.
Thumbs up, thumbs sideways and thumbs down – the week has brought news for many in the industry, including the FDA.
- Genentech Gets Green Light for Avastin for Lung Cancer – The agency approved Avastin (bevacizumab) for use in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer.
- Another Approvable Letter Issued – MGI Pharma Inc. received an approvable letter for Saforis Powder in UpTec for Oral Suspension, being investigated as treatment and prevention for oral mucositis. The company’s task from the agency was to conduct a new Phase III trial to establish efficacy. The company has at least four other drugs in Phase III studies. Note, as part of the tracking of approvable letters, Eye on FDA has begun a chart which you can reach by clicking on the link to the left under "Resources by Me".
- SSRIs May Poop Out – What many patients taking SSRI’s suspect about the durability of SSRIs was discussed in an article this month in Pharmaceutical Executive entitled "Downer for SSRI Makers" which explores a recent study in JAMA on the subject.
- Chorus of Criticism for the FDA – While the agency continues to appear to have absolutely no plan for dealing with image or crisis of any kind, the criticism of the FDA grew this week when the New England Journal of Medicine published an editorial endorsing the Institute of Medicine report findings and a paper was published in the Archives of Internal Medicine by members and former members of the FDA’s own Drug Safety and Risk Management Advisory Committee pointing to failings of the agency and called on the new Congress to instigate reforms, blaming the departing Congress for its inert response to the emerging issues faced by the agency. They shouldn’t take it personally, this Congress was inert vis a vis almost everyone.
That’s it for the week. Have a wonderful weekend.
