White House Advisers ask FDA to speed up decision on intravenous formulas of flu drugs - Reuters
Select flu related biotech/drug names trading higher following headlines relating to White House Advisers trying to speed up decision on intravenous formulas of flu drugsSee 13:21 comment. Reuters is also reporting the U.S. Food and Drug Administration should speed up decisions on approving intravenous formulations of flu drugs, including current drugs such as Relenen and Gilead's (GILD) Tamiflu... Some names to watch include: BCRX, NVAX, SVA, GILD, GSK, BAX HEB and CRXL.
Follow Up: Speed up US flu vaccine supply, says White House advisers - ReutersReuters reports that U.S. officials should help drug companies speed up bottling of swine flu vaccines, making some available for vaccinations by mid-September, instead of mid-October, White House science advisers said on Monday. "We recommend that the Department of Health and Human Services accelerate the availability of a portion of the vaccine supply to mid-September by having manufacturers begin to 'fill and finish' a subset of the bulk vaccine product at 15 micrograms. Such a decision would need to be taken almost immediately," the President's Council of Advisors on Science and Technology said in a report. The 15 micrograms is the minimum dose. Most experts believe people will need two doses of the vaccine, delivered at least two weeks apart, to develop full immunity to the new H1N1 flu. "All five manufacturers with orders to make H1N1 vaccine for the U.S. government have been asked to put their initially available vaccine in vials as soon as they are ready. This will move forward, even while awaiting results of clinical studies to confirm expected dosing, to assure the earliest possible availability of initial doses of vaccine," the report added. "Once ready, it takes approximately a month for vaccine to both be placed in vials and then for the needed testing to be completed before the vaccine is ready to use."