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 »

NEW YORK (Associated Press) – Shares of biotechnology company Targanta Therapeutics Inc. surged Monday after federal regulators posted a favorable review of the company’s antibiotic, ahead of a meeting to assess the product later this week.
Targanta shares advanced $2.62, or 40.1 percent, to $9.03 in midday trading.
The Cambridge, Mass.-based company asked the Food and Drug Administration to approve oritavancin for use against serious skin infections Read the rest of this entry »

County officials knew more than 14 years ago the creek was a special place. They vowed to protect its fragile ecosystem even as they allowed major development, including a new jail and dense housing, in nearby rural Clarksburg. But now they face a daunting challenge.
County scientists, in a detailed report that crunches thousands of bits of data about sediment and runoff, microscopic organisms, water speed and unhealthy chemicals, suggest that the Read the rest of this entry »

ViroPharma Inc.
said Tuesday the Food and Drug Administration granted its protein deficiency drug candidate Cinryze priority review.
The FDA designation means the review will be targeted within six months instead of the standard 10 months. Drug candidates are given priority review because they are aimed at conditions for which treatments are lacking.
Cinryze is aimed at treating acute attacks of hereditary angioedema, a protein deficiency that Read the rest of this entry »

One tech pioneer welcomed a new chief executive this week, while another lost its leader–at least temporarily.
After months of insisting that Steve Jobs’ health was a private matter with no impact on the company, Apple’s chief executive announced that he will
. His absence will stretch until the end of June.
Tim Cook, Apple’s chief operating officer, will run the company during Jobs’ absence, according to an
that was released to the media.
Read the rest of this entry »

-(Dow Jones)- The U.S. Food and Drug Administration said Tuesday
it’s continuing a safety review of Singulair and similar asthma medications to
see if they are linked to mood and behavior changes including suicide.
The agency said the safety review, first announced last March, “may take
months to complete.”
Merck & Co.’s
(MRK) Singulair and asked the company to submit additional
information. The agency also asked the manufacturers of drugs that Read the rest of this entry »

President Barack Obama is ordering a “complete review” of the Food and Drug Administration after it failed to detect shipments of salmonella-contaminated peanut products that have sickened more than 500 people and may be linked to as many as eight deaths, he told TODAY co-host Matt Lauer.
In an interview that aired Monday, Obama said the agency’s failure to recognize and intercept the products was only the latest of numerous “instances over Read the rest of this entry »

announced Friday that the U.S. Food and Drug Administration has accepted to review a new drug application for its anti-inflammatory nasal spray.
The Menlo Park's company's lead candidate, ROX-888, is designed to provide patients in the emergency room, leaving the ER or post surgery with fast-acting relief — taking effect in about 20 minutes —without the risk of addiction or other negative effects of narcotics.
The company said Read the rest of this entry »

Shares of
rose Wednesday after the Food and Drug Administration announced a meeting to review the company’s treatment for the inflammatory disorder gout.
The agency’s panel of outside experts will meet March 5 to review the safety and effectiveness of the drug Puricase, known generically as pegloticase. FDA is not required to follow the panel’s advice, though it often does.
The East Brunswick, N.J.-based company’s stock rose 22 cents, or 3.7 Read the rest of this entry »

Shares of
Questcor Pharmaceuticals Inc.
fell Wednesday after the company said the regulatory process for expanded approval of the drug Acthar is taking longer than expected.
The comments, from President and Chief Executive Don Bailey, came late Tuesday during a conference call to discuss the company’s fourth-quarter and 2008 profit results.
Shares plunged $1.36, or 20 percent, to close at $5.44. The stock has traded between $3.65 and $9.81 Read the rest of this entry »