August 5, 2009
MISSISSAUGA, ON
,
Feb. 19
/PRNewswire-FirstCall/ – Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has accepted Nuvo’s resubmission of its application for FDA approval to market Pennsaid in the Read the rest of this entry »

Amgen Inc.
said Wednesday the Food and Drug Administration accepted its application for the bone loss drug candidate denosumab, and the company expects the agency to make a ruling by Oct. 19.
) asked the FDA to approve the drug in December in a Biologics License Application. Regulators did not accept the application until Wednesday, but they intend to make their ruling 10 months from the date of the submission.
The biotechnology company wants Read the rest of this entry »

This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of Zevalin include risks
associated with preclinical and clinical developments in the biopharmaceutical
industry in general and with Zevalin in particular including, without
limitation, Read the rest of this entry »

BANGALORE, Nov 13 (Reuters) – AMAG Pharmaceuticals Inc said U.S. health regulators accepted the complete response for its experimental anemia drug, ferumoxytol, sending its shares soaring 86 percent.
‘We believe that AMAG’s prompt response to the FDA and the resultant Class 1 Response decreases timeline uncertainty, places the application under active review, and provides for timing consistent with an expected ferumoxytol launch in 1Q09,’ Needham Read the rest of this entry »

FRAMINGHAM, Mass.–(
)–The US Food and Drug Administration, or FDA, has accepted for review GTC
Biotherapeutics, Inc.
s (“GTC”, Nasdaq: GTCB)
Biologics License Application, or BLA, for ATryn
.
FDA
during a meeting that is being planned for January 2009. Based on the
achievement of these milestones, GTC has received $2 million in
additional milestone payments from OVATION Pharmaceuticals, Inc.
As previously Read the rest of this entry »

’s new drug application for its 80 milligram dose of toremifene, a treatment for the prevention of bone fractures for some men with prostate cancer.
GTx expects to hear within several weeks whether the FDA will give its application a priority or standard review. A priority review would give the product a faster track to market.
The drug would be marketed to men with prostate cancer on androgen deprivation therapy. ADT works by reducing testosterone Read the rest of this entry »

(Adds analysts’ comments, updates stock movement)
BANGALORE, Nov 13 (Reuters) – AMAG Pharmaceuticals Inc
(AMAG.O:
,
,
,
) said U.S. health regulators accepted the complete
response for its experimental anemia drug, ferumoxytol, sending
its shares soaring 86 percent.
“We believe that AMAG’s prompt response to the FDA and the
resultant Class 1 Response decreases timeline uncertainty,
places the application under active review, and provides Read the rest of this entry »

(RTTNews) - 
Monday, Cell Therapeutics, Inc. (CTIC:
) said the U.S. Food and Drug Administration, or FDA, has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application, or sBLA, for use of Zevalin as consolidation therapy for patients with follicular B-cell non-Hodgkin’s lymphoma who achieved a response to first-line therapy.
Cell Therapeutics noted Read the rest of this entry »

Drugmaker Merck & Co. said Friday the U.S. Food and Drug Administration has accepted its supplemental new drug application for the HIV drug Isentress.
The company wants approval to market the drug for use with other medicines in new patients. It is now approved only for patients already treated with other medicines for the virus that causes AIDS.
Isentress works by blocking the integrase enzyme, which takes DNA from the HIV virus and puts it inside Read the rest of this entry »

, with little public debate, has expanded its coverage of drugs for
.
Cancer doctors had clamored for the changes, saying that some of these treatments, known as off-label uses, were essential if patients were to receive the most up-to-date care. But for many such uses there is scant clinical evidence that the drugs are effective, despite costing as much as $10,000 a month. Because the drugs may represent a patient’s last hope, though, doctors Read the rest of this entry »