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SPPI.O
) said
U.S. regulators have extended the review date of its
experimental cancer drug, Zevalin, to July 2.
The decision by the U.S. Food and Drug Administration comes
after the regulator received a major amendment to the
Supplemental Biologics License Application for use of Zevalin
as a treatment for patients with indolent B-cell non-Hodgkin’s
lymphoma (NHL), the company said.
The drug has received priority review status from the FDA. Read the rest of this entry »
In his report on the use of performance-enhancing drugs in baseball,
dedicated more pages to Angel Presinal, a trainer based in the Dominican Republic, than he did to almost any of the dozens of players he cited.
and Larry Bigbie took up more than the five pages that those concerning Presinal did in the report, a fact that underscores the concerns Major League Baseball has had about Presinal over the past decade. During much of that time, he has Read the rest of this entry »
* Shares fall as much as 8 pct
(Recasts, adds analyst comments, updates share movement)
BANGALORE, Feb 23 (Reuters) – Spectrum Pharmaceuticals Inc
(
SPPI.O
) said U.S. regulators have extended the review date of
its experimental cancer drug, Zevalin, by three months to July
2.
The decision by the U.S. Food and Drug Administration comes
after the regulator received a major amendment to an
application for the additional use of Zevalin as first Read the rest of this entry »
Hemispherx Biopharma, Inc. received a letter from the Food and Drug Agency (FDA) indicating that the originally scheduled Prescription Drug User Fee Act (PDUFA) date on the Ampligen (Poly I:Poly C12U) New Drug Application (NDA) would be extended by three months âin order to provide time for a full review of the submission.â Additional data were received by the FDA within three months of the user fee goal date.
Due to constraints at the Read the rest of this entry »
COSTA MESA, Calif.–(BUSINESS WIRE)–Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that the
company is tentatively scheduled to meet with the U.S. Food and Drug
Administration (FDA) during the week of Oct. 20, 2008 to discuss any
remaining issues that the agency has about the use of Oxycyte
in a proposed Phase IIb clinical trial in Traumatic Brain Injury (TBI).
Oxycyte is the Company’s perfluorocarbon Read the rest of this entry »
ST. PAUL, Minn. — Authorities say a delegate to the Republican National Convention was robbed of jewelry and cash, worth a total somewhere between $50,000 and $150,000, after he took a woman to his Minneapolis hotel room.
29-year-old Gabriel Schwartz of Denver told police he met the woman in a bar, then took her to his hotel room at Hotel Ivy. Police say that once there, the woman made the man drinks and told him to get undressed.
He claims that Read the rest of this entry »
CHANHASSEN, Minn.–(
)–Life Time Fitness, Inc. (NYSE: LTM) today announced that the Company is
scheduled to release its Third Quarter 2008 fiscal results on Thursday,
October 23, 2008. A conference call to discuss the results will be held
at 10:00 a.m. ET.
Bahram Akradi, chairman and chief executive officer, Michael Robinson,
executive vice president and chief financial officer, and Kenneth
Cooper, vice president Read the rest of this entry »
Please Note: The materials provided herein contain projections and
other forward-looking statements regarding future events. Such
statements are just predictions and are subject to risks and
uncertainties that could cause the actual events or results to differ
materially. These risks and uncertainties include, among others:
the unpredictability of the duration and results of regulatory review of
New Read the rest of this entry »
- Walk in the park. Instead of meandering looking at the stars, grab a star chart, binoculars and a tripod to show your lady the universe. You could even do your homework and see if anything noteworthy is going on up above that night.
– The sunset. Don’t just take her to a mountain and cuddle while you watch the sun go down. While we admit that will probably always be romantic, try making an activity out of it and painting what you see instead. Read the rest of this entry »
Plans for a new medical facility in Yelm are still in the design stage and the estimated construction start date has been pushed back.
Yelm Family Medicine and Providence Health and Services are partnering in the project.
The 36,000-square-foot medical office building and surrounding medical park will be located near Golden Dragon restaurant, at the corner of State Highway 510 and Tahoma Boulevard.
“As it stands now we are continuing to Read the rest of this entry »