Thursday, May 22, 2008

BioKinetics launches E-Learning Service

BioK has a new service...

Online training for the process side of the GMP industry...

Previews are available for 2 courses...

Check it out...

Tuesday, May 20, 2008

Google releases Google Health for medical records

NEW YORK/SAN FRANCISCO (Reuters) - Google Inc on Monday unveiled Google Health, a long-anticipated U.S. health information service that combines the leading Web company's classic search services with a user's personal health records online.

The password-protected service, which can be found at, stores a user's basic medical history and gathers relevant information connected to their health conditions.

One feature includes a link to help users find doctors by location or specialization. The "virtual pillbox" notifies patients when they need to take medications and warns of potential drug interactions.

The service includes links to major U.S. pharmacies, doctors' groups and medical testing labs.

link to full article

Monday, May 19, 2008

Chinese SFDA crackdown to get house in order

The Chinese State Food and Drug Administration (SFDA) has revealed plans to tighten the drug registration review process as it attempts to improve standards in the nation.

At the regulatory body's monthly press conference a SFDA spokesman spelt out the policy which will only allow drug companies one opportunity to file their application documents.

By adopting a hard line stance the SFDA is sending out a strong message to its critics both at home and abroad who have cast aspersions on the integrity of the registration process.

SFDA spokesperson Yan Jiangying said: "In cases where a company's application does not satisfactorily prove the safety and efficacy of its product, the SFDA will no longer ask for further information, unlike in the past, but will simply reject the application outright."

This shift in policy is the result of an in-depth review of documents submitted to the SFDA between January and April this year to verify all information in the applications through pharmacological, toxicological and clinical trial analysis.

From this the SFDA discovered that some of the drug application documents were quite similar, which it believes is likely to signify that the company has fabricated the data.

link to full article

Monday, May 12, 2008

Pfizer to build Irish biologics plant

07-May-2008 - Pfizer's plans for a new €190m manufacturing plant in Shanbally, Ireland suggest that the firm is intent on fulfilling its pledge to become a "top five biologics producer in the next eight years."

The facility will produce small quantities of candidate drugs for clinical trials, creating around 100 jobs when it becomes operational at the end of 2009. It will be built on the 28-acre vacant lot adjacent to Pfizer's existing Ringaskiddy manufacturing unit that has been the subject of much speculation since the firm applied for planning permission last summer.

Pfizer spokeswoman Tara Delaney told that the unit will "manufacture and purify a variety of mammalian cell derived proteins at pilot scale on behalf of PGR&D [Pfizer Global Research and Development]," She went on to say that Jacobs Engineering will manage the construction project but added that it was too early to discuss the specific facilities that will be available at the site.

link to full article

Tuesday, May 06, 2008

and Here We Go...

The Chinese start the "active evasion" portion of this tragedy...asking if people who were taking a drug used in dialysis had kidney disease...

China accuses US of shoddy probe into tainted heparin

BEIJING - China's drug safety agency accused the United States on Tuesday of blocking Beijing's inquiry into a blood thinner linked to 81 deaths by refusing to provide details on victims and specifics about production.

Two Chinese experts who attended a conference on the drug, heparin, in suburban Washington, D.C., last month said the U.S. determined a contaminant was likely to blame without considering other possible factors.

"We need to resolve this in a scientific matter, not just by blaming a contaminant," said Jin Shaohong, a member of the drug evaluation committee of China's Food and Drug Administration. "I think it is too early to say that."

Besides the deaths, hundreds of patients have suffered severe allergic reactions to large doses of heparin, which is used in dialysis and other treatments.

The U.S. Food and Drug Administration said it suspects the problems stem from a contaminant the agency discovered in supplies of raw heparin coming from China — a compound derived from animal cartilage that so closely mimics heparin that routine tests can't detect it.

The Chinese experts said U.S. officials and Baxter International refused to give them information to probe the possibility that drug interactions, patients' medical histories or safety issues after the raw material left China may have played a role.

link to full article