Days and days of torrential and sporadic rains have taken their toll. With all the wet, the weeds in the garden prosper while my unplanted daisies languish in their little plastic cups waiting and yearning for the wide expanse of a yard to grow in. Today, I know how they feel.
- DDMAC Sends Untitled Letter to Sanofi – In a week of interesting warning and untitled letters (actually during a quarter of such interesting letters), the FDA sent Sanofi an untitled letter regarding a professional reprint carrier distributed at ASCO for containing an unsubstantiated superiority claim and an overstatement of efficacy. The letter is worth examining because it outlines the FDA's thinking of what kinds and what amounts of data are required to support efficacy and superiority claims after a head to head trial. It was also interesting because the letter was about events of the 2008 ASCO meeting and the letter was sent April 16, but only posted to the DDMAC Web site on May 13, almost a month later….
- Genentech Presenting 500 Abstracts Over 20 Kinds of Cancer at ASCO – Speaking of ASCO, the 2009 meeting is just about to get underway. Genentech has announced that the company will be presenting Phase III data on the use of Herceptin in the treatment of HER-2 positive stomach cancer and Phase II on Herceptin in treating HER-2 positive metastatitic breast cancer as well as Phase III's using Avastin in the treatment of colon cancer and Avastin/Tarceva in the treatment of lung cancer.
- No Grass Grows Under Osmetech's Feet – A company called Osmetech in Pasadena, California has submitted to FDA a test to screen for H1N1 flu virus. It was barely over a month ago that the first news reports of the H1N1 virus merged. A number of new pathogens have emerged over the past 30 years – SARS, West Nile Virus, HIV – it is fascinating to watch how quickly new tests and assays can be developed in response. The press release by the company says that the test is small and portable, but fails to say how quickly it reveals results.
- Cimzia Gets US Approval – UCB received word that the FDA approved its PEGylated anti-TNF (tumor necrosis factor) Cimzia for the treatment of adult patients with moderatly to severely active Rheumatoid Arthritis. An interesting twist – the company partnered with OXO to develop a syringe that patients could easily use.
That's it for me this week folks. Have a good weekend. And please, send thoughts of sunshine our way.