First frost has not yet arrived, but there is anticipation it could happen tonight. There will be no frost on my pumpkin this year, as you may have noted in the Weekly Roundup two weeks ago, the pumpkin suffered a diversion after meeting a hungry squirrel. A friend in Slovakia wrote last week of a first snow dusting. We are tilting to shorter and shorter hours of daylight. I have been digging out my favorite cold-weather recipes and purchased some new scarves, hats and gloves yesterday. I guess I'm ready…
And in the meantime, here is a bit of what happened last week and this week:
- Amylin, Lilly and Alkermes Get CRL for Bydureon (last week) – The FDA issued a Complete Response Letter regarding an extended release version of exenatide. The companies were forthcoming in the press release on the topic saying that the FDA was requesting a "thorough QT study" of the use of the drug at levels higher than typical therapeutic levels. This will cause significant delay, with the companies saying they will file a response in late 2011.
- FDA Approved Boehringer Ingelheim's Pradaxa to Prevent Stroke in People with Atrial Fibrillation (last week) – Boehringer Ingelheim announced this week that the FDA had approved its anti-coagulant Pradaxa for use in preventing blood clots in people with atrial fibrillation. According to the release by the company, it is the first approval of an anti-coagulant in fifty years. The FDA stated that the trial was a head to head against warfarin and that results showed that the patients being treated with Pradaxa in the trial had fewer strokes than those treated with warfarin.
- FDA Approves Teflaro - The FDA announced approval of Teflaro (ceftaroline fosamil) for the treatment of bacterial skin infections, including MRSA. Given the high profile that such infections have seen in media reports, the announcement is not only welcome news for Forest Labs, the manufacturer, but for those treating and receiving treatment for such infections.
- New Treatment for Schizophrenia Approved – The agency also announced this week approval for Latuda, manufacturered by Sunovion Pharmaceuticals, formerly known as Sepracor. It is an oral, once daily treatment and the company stated that it would likely be available the first quarter of 2011.
- Approval for Rare Leukemia Treatment – A new indication was approved for Sprycel (dasatinib) under accelerated approval for the treatment of a rare blood cancer known as Ph+ CP-CML. Sprycel, an oral kinase inhibitor, is the third drug approved to treat this condition and is manufactured by Bristol Myers Squibb.
- Complete Response Letter for Qnexa – Vivus announced the receipt of a Complete Response Letter for its weight loss drug Qnexa. The release stated that the letter covered five areas – clinical, labeling, REMS, safety update and drug scheduling. The company stated that they would be responding to the release in six weeks.
That's it for me this week folks. Have a good weekend.