Friday, September 30, 2005

Liars' brains 'are not the same'

Habitual liars' brains differ from those of honest people, a study says.
A University of Southern California team studied 49 people and found those known to be pathological liars had up to 26% more white matter than others.

White matter transmits information and grey matter processes it. Having more white matter in the prefrontal cortex may aid lying, the researchers said,

But the British Journal of Psychiatry said there were likely to be more differences in the brains of liars.

Link to

Tuesday, September 27, 2005

Genzyme unveils $540m expansion plan for manufacturing, R&D

27/09/2005 - US biotechnology major Genzyme officially opened four European facilities last week as part of a investment package eventually expected to cost $540 million (€449m).

The series of openings, which will see Genzyme become one of the largest biotechnolgy operations in Europe, with over 2,000 staff, includes.

a site in Geel, Belgium, for the production of recombinant monoclonal antibodies.
an $8 million centre at its UK manufacturing site in Haverhill, to carry out process development and clinical trial support for renal disease products;
a $157 million fill-and-finish plant for biologic medicines in Waterford, Ireland; and
a drug discovery research facility in Cambridge, UK, that will employ 150 people within five years.
The moves comes in the wake of a number of other large-scale investments in biological drugs production capacity, from the likes of Genentech, GlaxoSmithKline and Bristol-Myers Squibb.

link to full article in

FDA Chief Wants Transformation in Medicine

WASHINGTON - The incoming head of the Food and Drug Administration says the agency must stay on top of emerging discoveries into the mechanisms of disease that may lead to new treatments that can be tailored to individual patients.

Dr. Andrew C. von Eschenbach, tapped by President Bush to at least temporarily head the regulatory agency, said Sunday that recent research will lead to a new kind of health care.

"We are discovering so much about diseases like cancer at the molecular level," von Eschenbach, a urologic surgeon by training, said in an interview with The Associated Press.

Based on these understandings, physicians will be able to devise treatments more effectively matched to a specific patient and his or her condition, he said. That's a fundamental shift: Doctors now treat illnesses based primarily on how well other people have responded to a given treatment.

Von Eschenbach has a reputation for optimism. As head of the National Cancer Institute, he outlined an ambitious goal of eliminating suffering and death due to cancer and turning it into a manageable disease by 2015 — an aim regarded by some as unlikely.

link to story

Monday, September 26, 2005

Crawford resigns as FDA Commissioner

Update- 28Sep05

FDA Chief's Resignation Comes As Surprise

WASHINGTON - Food and Drug Administration Commissioner Lester Crawford is out only two months after the Senate confirmed him to run the agency. President Bush designated Dr. Andrew C. von Eschenbach, the director of the National Cancer Institute, the acting replacement.

Crawford's surprise resignation, submitted Friday and effective immediately, gave no specific reason for his departure. "It is time at the age of 67, to step aside," he wrote in his resignation letter.

Crawford's tenure was marked by increasing criticism of the agency by those who contended it had become more interested in politics than in its mission to protect consumers.

Link to full article

26/09/2005 - The US Food and Drug Administration (FDA) has found itself once again without a permanent Commissioner after the current incumbent - Lester Crawford - resigned after 18 months in the post.

Crawford was appointed acting FDA Commissioner March 2004, after having stepped into the job on an interim basis on two prior occasions. He has been acting Commissioner since Mark McClellan departure left to head up the Centres for Medicare & Medicaid Services, and after a long, contentious and drawn-out appraisal process was finally granted the permanent position in July.

link from in-pharmatech

Friday, September 23, 2005

RABS Definition Paper Finalized

A restricted access barrier system (RABS) is a type of barrier isolation system that includes several specific characteristics; however, there is great confusion in the industry about RABS and how they differ from other forms of advanced aseptic processing.

In order to assist regulatory and industry professionals in reaching an understanding of the requirements for RABS, the FDA encouraged ISPE to provide a clearer definition of the elements that characterize RABS technology. Following ISPE's annual Barrier Isolation Technology Conference (part of the 2005 Washington Conferences in June), a group of attendees, speakers, and organizers met to create a definition white paper for RABS. The team posted the draft paper for public comment on the ISPE Web site during July and submitted a final version to the FDA. Released on 16 August, the positioning paper defines RABS for the industry and describes the "quality by design" and operational characteristics that must be present to constitute a RABS.

"I think this group's constructive work in describing RABS will be helpful to both industry and FDA. This appears to be the first, and certainly the most current and comprehensive, RABS definition offered by a technical organization," said Rick Friedman, Team Leader for Guidance and Policy at the FDA's Center for Drug Evaluation and Research. "Now, companies will be able to start sterile facility design discussions with a concrete definition to refer to. I expect this contribution to be an instrumental step toward reaching consensus on a formal definition."

link to article

Wednesday, September 21, 2005

Drug firms launch Web site to disclose trials data

LONDON (Reuters) - The global pharmaceutical industry launched a new Web site on Wednesday giving details of clinical trials on new medicines, in a bid to allay patient fears over drug safety.

The move follows criticism that companies manipulate or suppress results of clinical studies in order to come up with favorable conclusions.

link to full story at

This could be a good thing...

just might be a bit boring to read.

Thursday, September 15, 2005

Report sees boom time ahead for biopharma CMOs

good story...lot's to digest...

15/09/2005 - Pharmaceutical companies are increasingly looking to retain their internal focus on research and development (R&D) and marketing while outsourcing their manufacturing processes, thus fueling a growing demand for the manufacturing capacities of contract manufacturing organisations (CMOs).

This trend will drive a doubling in revenues in the pharmaceutical contract manufacturing sector from $12.38 billion (€10.13bn) in 2004 to $25.70 billion in 2005, according to a report from consulting firm Frost & Sullivan.

link from

Sandoz takes issue with FDA over biogenerics

I didn't think you could sue the FDA...

15/09/2005 - Sandoz, the generic drug unit of Swiss pharmaceutical group Novartis, has filed a law suit against the US Food and Drug Administration (FDA) alleging that the agency is dragging its feet in a review of a ‘biogeneric’ drug filed by the company.

Sandoz is calling for a swift ruling on its pending application to market its human growth hormone product Omnitrope, based on an abbreviated approval route that does not require the conduct of extensive clinical trials

link from

Tuesday, September 13, 2005

Murdock Biotech Plan Valued At $1B; 5,000 Jobs In Bio NC

Its the job creation thing again!!!...

I sense a pattern...

but I still want to know what work is going to come out of all this...

California financier David Murdock's plan for establishing a biotechnology research campus in Kannapolis could grow to a $1 billion development that would create 5,000 jobs. Murdock, who owns Dole Food Co. Inc. and real estate development firm Castle & Cooke Inc., unveiled his proposal Monday for transforming a 250-acre former Pillowtex Corp. plant and an adjacent 100 acres in downtown Kannapolis into the North Carolina Research Campus. The campus, which Murdock wants to develop in conjunction with the University of North Carolina system, would create 5,000 jobs. But spinoff employment could eventually grow to 30,000, says John Cox, chief executive of the Cabarrus Regional Chamber of Commerce.

link from

Monday, September 12, 2005

GSK continues apace with flu vaccine empire building

08/09/2005 - If there was any doubt that GlaxoSmithKline aims to become the premier world supplier of influenza vaccine, it should be laid to rest by yesterday’s news that the number two drugmaker is buying Canadian company ID Biomedical.

The move follows the company's decision to buy a facility from Wyeth in the US that will be turned over to flu vaccine production, as well as its announcement that it will double production at a flu vaccine facility in Dresden, Germany,
Until last year, the flu vaccine market was split mainly between two players – Chiron and Sanofi Pasteur – with other players lagging well behind the leaders. Now, the manufacturing problems that have beset Chiron and led to vaccine shortages in the 2004/5 flu season have opened up the market, and GSK itself has benefited with approval of its own Fluarix vaccine by the US Food and Drug Administration (FDA) under a special fast-track system.

link for full article

Biotech Firm May Bring 250 Jobs To Phoenix, Arizona

looks like biotech is the next job creation engine...

Phoenix beat out San Diego, San Francisco and Seattle as the new headquarters for a Canadian biotech firm that also is considering building a protein manufacturing plant in the Valley. InNexus Biotechnology Inc., which develops drugs from naturally occurring proteins, is consolidating operations and moving to Phoenix to conduct clinical trials for its cancer and heart drugs. Ultimately, the company could employ as many as 250 people here. Plans call for taking an initial 15,000 square feet within Mayo Clinic's 110,000-square-foot research complex at 136th Street and Shea Boulevard in Scottsdale. Written into the 10-year lease are plans for expansion. About 40 people will be employed at that lab to begin with, but as the company expands, as many as 100 will work there, said Jeff Morhet, InNexus chief operating officer.

link from

Sunday, September 11, 2005

Wyeth Pharmaceuticals Opens Ireland Plant

Wyeth Pharmaceuticals Opens $2 Billion Plant in Ireland, Expects to Employ 1,000 People

DUBLIN, Ireland (AP) -- Wyeth Co. officially opened a $2 billion Irish production facility Thursday, a move that will make the U.S. company the biggest pharmaceutical employer in Ireland.

The Madison, N.J.-based company expects to employ about 1,000 people, including 100 researchers developing new products, at its 1.2 million-square-foot campus south of Dublin within the next four years.

link from AP

Europeans launch $4 bln vaccines scheme

LONDON, Sept 9 - European countries launched a new scheme on Friday to provide $4 billion in life-saving vaccines to millions of poor children, but critics said the project was flawed and much more money was needed to address the problem.

link from

Wednesday, September 07, 2005

Biogenerics market set to explode?

Regulatory obstacles to the development of the market for biogeneric drugs are falling down, and the first products are set to reach the markets of North America and Europe in 2006-7, according to consulting firm Frost & Sullivan.

The markets in Europe and the US alone have the potential to generate sales of $16.39 billion by 2011, according to the company.

yeah, but will this generate any work???...

link from

Scientists strike gold in nanoparticle research

yeah, another nanotech post...

story from

Scientists in the US have developed a way to rapidly generate libraries of gold nanoparticles that could have an array of applications in the pharmaceutical industry, from target and drug discovery studies to drug delivery.

The team, headed by Jim Hutchinson of the University of Oregon's Materials Science Institute, said their technique allows rapid incorporation of specific functionality into the gold nanoparticles and can be used to incorporate a wide range of functional groups. It can also provide access to new materials inaccessible by other methods, claims the group.

Sunday, September 04, 2005

FDA Approves New Influenza Vaccine for Upcoming Flu Season

The Food and Drug Administration (FDA) today approved Fluarix, an influenza vaccine for adults that contains inactivated virus. Fluarix is approved to immunize adults 18 years of age and older against influenza virus types A and B contained in the vaccine. Influenza is also commonly called the flu.