Do you remember what the Morning Mayor used to say? Every brand new day should be unwrapped like a precious gift. So go ahead, open yours. And after you do so, grab a cup of something refreshing and take a peek at these…
Baxter Says Heparin Legal Costs Are Insignificant (The Chicago Tribune)
Roche Targets Diabetes To [...]

This is the international version of the blame game. Last month, Chinese officials voiced doubt that a contaminant identified in Heparin caused 81 deaths and severe allergic reactions in hundreds of Americans, and suggested the problem could have occurred in the US. Now, they insist the Chinese-made blood thinner wasn’t to blame and accused Baxter [...]

A House investigator charged that the FDA’s Office of Chief Counsel has undermined a congressional drug safety investigation, InsideHealthPolicy* reports.
Energy and Commerce Committee investigator David Nelson told a bipartisan committee the probe was stymied because the FDA office denied investigators access to documents and personnel, the web site wrote. Committee investigators interviewed operational and [...]

Artificial blood products increased the risk of death by 30 percent and almost tripled the risk of heart attacks in 16 clinical trials, according to a study in the Journal of the American Medical Association. The researchers write that the FDA should have stopped the studies eight years ago, but meanwhile five trials are still [...]

Although the FDA increased inspections of foreign drug plants last year, the agency still checked only 11 percent of the sites that supply pharmaceutical ingredients to the US market. That’s what GAO health care director Marcia Crosse will tell the House Energy and Commerce Committee this morning at a hearing to discuss the FDA’s oversight [...]

And so the new cooperation pact with the US Health and Human Services and the FDA begins with a disagreement - Chinese officials are voicing doubts that a contaminant identified in Heparin was the root cause of 81 deaths and severe allergic reactions in hundreds of Americans, the Associated Press reports.
The officials suggested at an [...]

That’s what FDA commish Andy von Eschenbach said at Senate hearing, although he didn’t specify who added the contaminant and Baxter International maintains the contamination occurred before the blood thinner reached its supplier, Bloomberg News reports. Some samples of Baxter’s heparin, whose main ingredient was made from pig intestines and imported from China, were contaminated [...]

File this under ‘Say Uncle.’ A dozen drug and device makers have told Chuck Grassley, the Iowa Republican, that they have plans or are working on plans to publicly disclose grants to outside groups, and the details will be provided on each company’s Web sites, the Associated Press reports. In particular, Grassley is interested in [...]

Since the moment Heparin became a household word, Baxter International has been vulnerable. With nearly 800 serious adverse events and 19 deaths attributed to its blood thinner, the healthcare company has what attorneys call exposure. Of course, this should not come as a surprise in this litigous world. Still, the contaminated ingredient was introduced in [...]

In a reversal of its earlier stance, China’s drug safety agency is ordering local authorities to tighten controls on production of the Heparin blood-thinner that has been linked to nearly 800 allergic reactions and 19 deaths in the US, the Associated Press reports.
The State FDA issued the order in a notice, which was seen on [...]