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 »

Here are some of the stories that will be on-line Sunday, as well as in our print editions this weekend,
stories you haven’t read in any other news source!
says crime is down, but the 2008
statistics tell a different story.
Crime is down in some categories, true, but not in murder and rape. In the wake of a tragic shooting in the quiet Hamilton Park neighborhood on Tuesday morning, a block from McNair Academic High School, downtown residents Read the rest of this entry »

Appalled and frustrated come to mind upon learning that for years there have been former Hoboken city employees, classified as ineligible, receiving taxpayer funded healthcare benefits. This goes beyond mismanagement, seems that Judy Tripodi, our state fiscal monitor, has uncovered yet another one of the many unethical practices plaguing Hoboken.
What is even more troubling and should be of great concern especially with a Mayoral election this Read the rest of this entry »

Shares of
plummeted Thursday evening after the company said federal regulators pushed back the target date to review the company’s treatment for gout.
Savient said in a statement the Food and Drug Administration has extended its review for the drug by three months until July 30. FDA also notified the company it will likely reschedule a meeting planned for March 5 to review the company’s drug.
Savient has asked the FDA to approve the injectable 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 »

(RTTNews) - 
Savient Pharmaceuticals, Inc. (SVNT:
) Thursday said that the US Food and Drug administration has extended the review period of the company’s gout drug by three months to July 30, 2009, following the submission of a major amendment to the previously submitted Biologics License Application, which was granted priority review. Following the news, Savient shares plunged more than 25%, in after-hour trading, Read the rest of this entry »

WASHINGTON, Dec 31 (Reuters) – King Pharmaceuticals Inc.
(
KG.N
) said on Wednesday that U.S. health regulators have not
yet completed their review of its experimental painkiller
Embeda and that the review will likely extend into early 2009.
King did not give a reason for the extension of the review.
However, the U.S. Food and Drug Administration has repeatedly
failed this year to complete its evaluation of drugs that have
been filed for approval Read the rest of this entry »

Here are some of the stories that will be on-line Sunday, as well as in our print editions this weekend,
stories you haven’t read in any other news source!
says crime is down, but the 2008
statistics tell a different story.
Crime is down in some categories, true, but not in murder and rape. In the wake of a tragic shooting in the quiet Hamilton Park neighborhood on Tuesday morning, a block from McNair Academic High School, downtown residents 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 ‘in order to provide time for a full review of the submission.’ 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 »

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 »