Monday, January 30, 2006

The ISPE Survey

I got the ISPE survey regarding the professional certification program...

here's the link to the main page...

hard to figure if they're getting the right emphasis...

very little if anything on public safety...heavy on validation, commissioning , and development activities...

Pataki announces biotechnology grant program

The job creration machine keeps on rolling...

ALBANY, N.Y. -- Gov. George Pataki and the Republican-led state Senate are backing a program that aims to generate $800 million in new investment in biotechnology and medical research at institutions across the state.

The program, announced by Pataki and Senate Majority Leader Joseph Bruno, would create a $200 million grant initiative they hope will generate another $600 million in federal, not-for-profit and private sector matching funds.

The initiative, first announced earlier this month in the governor's State of the State address, will fund research at universities and hospitals around New York.

The plan would establish a two-part $200 million program including $40 million in capital funding, already authorized, and $160 million financed by the state Charitable Asset Foundation, a charitable trust formed with the proceeds of the Empire Blue Cross Blue Shield conversion to a for-profit company. The money would be used to recruit researchers and scientists and to buy new technology and equipment.

link to full article from

Friday, January 27, 2006

Gates Pledges $900 Million for TB Research

DAVOS, Switzerland (AP) -- Bill Gates said Friday his charitable foundation will boost its funding for tuberculosis eradication from its current level of $300 million to $900 million during the next decade.

The effort is part of a larger campaign against tuberculosis announced at the World Economic Forum. The disease killed 1.6 million people last year.

The announcement came as Nigerian President Olusegun Obasanjo, British treasury chief Gordon Brown and Gates called for help to treat 50 million people and prevent 14 million tuberculosis deaths worldwide over the next decade.

"This is a very tough disease," the Microsoft Corp. chairman and co-founder said. "It is going to take all of us - private sector, the pharmaceutical companies, philanthropy and governments in countries that have the disease - to participate as well."

link to full AP article

Tuesday, January 24, 2006

FDA Panel Recommends OTC Weight-Loss Pill

and I've been trying to lose weight by eating less...How old-fashioned...

WASHINGTON - Federal health advisers voted Monday to recommend over-the-counter sales of a weight-loss pill now sold only with a prescription.

GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill already marketed in prescription form as Xenical. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.

A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing. The agency usually follows the recommendations of its outside panels of experts, but its final decision could take months. If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales. Roche will continue selling Xenical regardless.

"We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.

link to full AP article

Friday, January 20, 2006

Biotech Center To Match VC Funding With Loans

Great idea, except the money can't be used for physical facilities...

Bootstrap biotechnology companies will have an easier time gaining traction thanks to a program launched by the North Carolina Biotechnology Center that will match venture capital investments with loans of up to $250,000. The Strategic Growth Award is designed to offer startup companies an additional avenue to help alleviate funding shortfalls that often occur between seed-funding stages and later venture capital investments, according to a written statement from the biotechnology center. SGA loans won't be restricted solely to research funding, say biotech center officials. The new loans can also be used for hiring employees, securing patent rights and pursuing business development and licensing opportunities. The loans, however, must be matched with an equal investment from a venture capital firm. While SGA loans cannot be used for physical facilities or to compensate corporate executives, these restrictions will not apply to the matching venture funds, officials say. The loan program is open only to North Carolina biotech companies involved in life sciences, natural products, agriculture, veterinary medicine or environmental endeavors. Triangle Business Journal reported in its Oct. 14, 2005 print edition that the Biotech Center was considering the loan program. The North Carolina Biotechnology Center is a private, nonprofit corporation headquartered near Research Triangle Park and supported by the North Carolina General Assembly. The organization operates four additional offices in Greenville, Wilmington, Winston-Salem and Asheville, with plans for a fifth office in Charlotte.

link to story on

Monday, January 16, 2006

The FDA celebrates 100 Years!!!

link to site

This week in FDA history- January 10, 1961:

External D&C No. 15, a red color additive widely used in cosmetics before it was taken off the FDA's list of approved colors in 1960 because of safety concerns, is cleared for uses outside of the body. But this leaves fans of rosy lips little to smile about, since this "external use" doesn't include lipsticks.

Wednesday, January 11, 2006

MedImmune inflates flu vaccine production capacity to boost market presence

11/01/2006 - MedImmune will soon ramp up production of its intranasal flu vaccine after the US Food and Drug Administration (FDA) approved its new and larger flu vaccine manufacturing facility in Speke, England.

The new facility is 10 times larger than MedImmune's existing manufacturing facility in Speke, and will allow the company to produce up to 15 million doses per month, or about 90 million doses per influenza manufacturing season, of its trivalent, intranasal flu vaccine, FluMist.
This is a mammoth increase in vaccine production considering the company only produced 3 million doses of FluMist this year and the decision to ramp up production may seem somewhat ambitious.

link to full article

Tuesday, January 10, 2006

Penicillin and Amoxicillin's days are numbered

03/01/2006 - The threat of antibiotic resistance reared its ugly head again after US researchers found that the most common antibiotic treatments do not work in a significant number of cases, leading for calls to find viable alternatives to ageing, established, antibiotics.

Antibiotic resistance has become a problem in the pharmaceutical industry that no one wants to or knows how to deal with. This could be because the acceptance of a need for alternatives would essentially mean pharma has lost confidence of antibiotics such as penicillin and amoxicillin.
Researchers from the University of Rochester started with the analysis of data from 11,426 children who has suffered a common throat infection.

They found that 25 per cent of children given penicillin, along with 18 per cent given amoxicillin treatment needed further treatment within weeks.

link to full article

Thursday, January 05, 2006

Coffee may lower breast cancer risk for some women

NEW YORK (Reuters Health) - Women with BRCA1 gene mutations, which confer a high risk of developing breast cancer, might decrease their risk by drinking a lot of coffee, according to a multicenter team of investigators.

Dr. Steven A. Narod, of the University of Toronto, Ontario, and colleagues examined the association between coffee consumption and the risk of breast cancer among 1690 high-risk women with BRCA1 or BRCA2 mutations.

The study included women from 40 clinical centers in four countries. A self-administered questionnaire was used to assess the average lifetime coffee consumption.

The likelihood of developing breast cancer among BRCA mutation carriers who drank 1 to 3 cups of coffee daily, 4 to 5 cups, or 6 or more cups was reduced by 10 percent, 25 percent and 69 percent, respectively, compared to those who drank no coffee, according to the report in the International Journal of Cancer.

When the investigators classified the women by mutation status, they found significant protection from coffee

link to for full article

Wednesday, January 04, 2006

New blow to S Korea clone work

South Korea's disgraced human cloning scientist did not produce any stem cells tailored to individual patients as claimed, a panel has concluded.
A Seoul National University panel said it believed that Hwang Woo-suk never had the data he said he had.

Dr Hwang quit last week after the panel said some research was fabricated.

Correspondents say the finding is important as individually tailored stem cells were seen as a key to treating diseases like diabetes and Alzheimers.

The scientist maintains he has developed technology to produce such stem cells.

The panel said it would continue its investigation into other research by Dr Hwang, including the authenticity of a cloned Afghan hound which was claimed to be the world's first cloned dog.

link to full article by BBC