| Can Dirt Do a Little Good? Some experts say exposure to a variety of bacteria, viruses and parasitic worms early in life helps prime a child's immune system. That raises a question: Are we too clean? online.wsj.com |
Vivus's Qnexa Gets Thumbs Down From Mixed FDA Panel Ruthanne Williams Roussel submits:As many will know by now, an FDA briefing panel July 15 recommended against approval of Vivus' (VVUS) obesity drug candidate Qnexa by a vote of 10 to 6. This was originally announced as a vote of 9 to 7, but a new electronic voting system was in use, and it must have been a little confusing, because one panelist later claimed that they had unintentionally voted "Yes" for approval instead of "No" against. (Insert "Jim, I'm a doctor, not an electronic voter!" joke here.) The main concerns cited about Qnexa were:Complete Story » seekingalpha.com |
Array BioPharma to Report Financial Results for the Fourth Quarter and Full Year of Fiscal 2010 on August 9, 2010 (Business Wire) BOULDER, Colo.----Array BioPharma Inc. will report financial results for the fourth quarter and full year of fiscal 2010 on Monday, August 9, 2010, and will hold a conference call on Tuesday, August 10, 2010 at 9:00 a.m. eastern time to discuss these results. us.rd.yahoo.com |
What Medicare Will Ask About Dendreon's Provenge Pharmalot submits: There is yet another twist in the ongoing and always interesting Provenge saga. The Centers for Medicare & Medicaid Services, which last June issued a surprise decision to conduct a National Coverage Analysis, which will be used for coverage guidance by Medicare contractors, has released the questions to be answered at a Nov. 17 panel meeting and the focus is on on-label efficacy. The NCA, for those who may not recall, stunned all sorts of people because such reviews do not occur very often (see here and here). Dendreon (DNDN) execs subsequently downplayed the move by telling analysts NCA was sparked by concerns of off-label use, although CMS has been cryptic about its reasoning other than to point to the fact that Provenge is the first in a new class of treatments that use a patient’s own cells to stimulate the body’s immune system in an approach known as immunotherapy.Complete Story » seekingalpha.com |
Genzyme Profit Soars Genzyme's third-quarter earnings soared, thanks to slightly lower operating costs and increased revenue. online.wsj.com |