January 12, 2009 7:31 a.m. EST
Miami, FL (AHN) – Federal regulators approved the use of a controversial drug to treat high cholesterol last week.
The Food and Drug Administration gave Vytorin the OK a year after a study came out suggesting it wasn’t any more effective than Zocor in lowering bad cholesterol.
Vytorin is a combination of simvastatin, the generic name for Zocor, and ezetimibe.
But now the FDA said a recent trial found a 56-percent Read the rest of this entry »

Dyax Corp.
said Wednesday a Food and Drug Administration advisory panel recommended approval of the company’s developing treatment for a genetic condition that can lead to dangerous swelling.
The drug candidate is called DX-88 and is aimed at treating the condition called hereditary angioedema. While the FDA does not have to approve the drug, it usually follows the advice of its expert panels. The panel vote was slim, with six recommending approval Read the rest of this entry »

Memphis-based GTx announced Tuesday morning that it had submitted a new drug application with the U.S. Food and Drug Administration for the prevention of bone fractures in men undergoing drug therapy for prostate cancer.
Bone loss is a side effect of androgen deprivation therapy (ADT), which is the primary treatment for advanced prostate cancer. GTx has filed an application for toremifene 80 milligrams, an oral selective estrogen receptor modulator Read the rest of this entry »

., a Watertown biotechnology company, said it has sold the rights and assets of bevirimat, a potential HIV drug, for $7 million.
The buyer is another biotech firm,
of Salt Lake City, Panacos said.
In a statement, Panacos president and chief executive Alan W. Dunton said: “Our goal has been to develop drugs with novel mechanisms of action to give people living with HIV new treatment options. In order to achieve this goal and to manage capital 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 »

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 »

The US Food and Drug Administration has given marketing approval to a new drug that lowers levels of uric acid in the blood of patients with
gout: the current treatment for the condition was developed over 40 years ago. The new drug is called ULORIC (generic name febuxostat) and Takeda
Pharmaceuticals North America is the sole developer and marketer of the product in the US.
According to a statement from Takeda, febuxostat is a new highly potent Read the rest of this entry »

WASHINGTON (AP) — The top Republican on the House Veterans Affairs Committee demanded Wednesday that the VA explain how it allowed software glitches to put the medical care of patients at its health centers nationwide at risk.
“I am deeply concerned about the consequences on patient care that could have resulted from this ’software glitch’ and that mistakes were not disclosed to patients who were directly affected,” said Rep. Steve Buyer, Read the rest of this entry »

WASHINGTON (AP) — Food and Drug Administration officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses.
The final guidelines, which have been criticized by some lawmakers as too lenient, allow companies to distribute articles about their products to doctors — even when they involve uses that have not been federally approved.
The FDA Read the rest of this entry »

THURSDAY, Feb. 19 (HealthDay News) — A powerful clot-busting drug approved by the U.S. Food and Drug Administration for use in stroke patients in 1996 is still rarely used in Medicare patients, new research shows.
Only 2.4 percent of the more than 495,000 admissions for stroke at the 4,750 hospitals evaluated were given tissue plasminogen activator (tPA), said study author Dr. Dawn Kleindorfer, an associate professor of neurology at the University Read the rest of this entry »