Wednesday, July 30, 2008

Heparin taint tied to deaths

FDA: 3 fatalities linked to material in Baxter product

The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc.

In an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animallike substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

"We have what looks like a cause and effect in some patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. "We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain."

link to full article

Thursday, July 24, 2008

Good and Evil: A Cancer Vaccine from Tobacco Plants

Tobacco makes a comeback!!!

In the first human trial of its kind, a vaccine grown in genetically engineered tobacco plants has proved to be safe, paving the way to one day use it to help combat a potentially fatal form of non-Hodgkin's lymphoma.

Researchers report in the Proceedings of the National Academy of Sciences USA that the experimental vaccine triggered the immune systems of 11 of 16 volunteers (with so-called follicular B-cell lymphoma) to attack their tumors without any apparent dangerous side effects.

Some 18,000 Americans, typically between the ages of 60 and 65, are diagnosed annually with this incurable, slow-growing type of cancer. Study coauthor Ronald Levy, an oncologist at the Stanford University School of Medicine, says that physicians generally take their cues from the disease, waiting to see how fast it is moving—and treating it with toxic chemotherapy (sometimes with radiation) only if it becomes aggressive.

He says that if future trials are successful, the experimental vaccine, which can be made relatively quickly and cheaply, could become a short-term therapy administered immediately after diagnosis to try to keep tumors in check.

"This may not be a replacement for chemotherapies, but a supplement for them," Levy says. "A technology that is fast, like this one, is more amenable to a watchful waiting approach than a technology that is slow to produce."

link to full article

Monday, July 21, 2008

Senate Appropriations Committee Approves $2 Billion for FDA

Now they're gonna regulate the #@&?#!!! out of us...

The Senate Appropriations Committee unanimously passed an appropriations markup measure Thursday, providing the FDA with a $2.04 billion fiscal 2009 budget.

This amount is $324.6 million more than the agency initially received for fiscal 2008. The measure will have no number until it is introduced in the full Senate.

link to full article

Thursday, July 17, 2008

FDA Moves Forward With Exempting Phase I Drugs From GMPs

So much for those bothersome regulations...

More than two years after withdrawing a final rule that would have exempted investigational drugs in Phase I testing from certain good manufacturing practice (GMP) regulations, the FDA is issuing a final rule to do just that.

The new rule, which amends the GMP regulation with the exact same language as the withdrawn rule, was published in Tuesday’s Federal Register. Slated to take effect Sept. 15, it will apply to small-molecule drugs and biologics, including vaccines and gene therapy products.

“FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture,” the agency says.

link to full article

Wednesday, July 16, 2008

Even India is slowing down!!!

Biotech growth slows for first time in 5 years

Bangalore: After five straight years of rapid expansion, India’s biotechnology industry slowed to 20% growth in the year to March, down from more than 30% in the previous years, largely due to a rising rupee and price pressures in the global market.

link to full article

Wednesday, July 09, 2008

NJ to lose more than 800 pharmaceutical jobs

New Jersey gets pounded!!!...

More than 800 pharmaceutical jobs leaving New Jersey as part of major restructuring

NEW YORK (Associated Press) - More than 800 pharmaceutical jobs will be leaving New Jersey starting in August.

Most of the job cuts and transfers are part of major previously announced restructurings at Johnson & Johnson and Schering-Plough Corp. This week, the companies specified how many of those jobs would be lost at New Jersey locations.

Schering-Plough, based in Kenilworth, is cutting 500 jobs. New Brunswick-based J&J is eliminating 22 jobs at its Ortho Biotech unit in Bridgewater, shifting another 260 to its Centocor unit in Horsham, Pa., and cutting another 267 Ortho Biotect jobs outside New Jersey.

link to full article

Tuesday, July 08, 2008

The Race to China

Interesting post from Pharmalot regarding Pharma's move to China...

I understand the drivers behind these types of efforts, something to spruce up yet another bland corporate report,...something for senior management to tout as "the strategy"...reducing the costs of an already ineffective R+D effort, etc, etc...

These drivers will have more and more companies jumping on the bandwagon...

How many of these companies are backing up these efforts with a robust plan for maintaining the quality of the products they intend to produce?...and yes, that includes research efforts...or are they just looking at the cost savings?...

Wednesday, July 02, 2008

Study finds long benefit in illegal mushroom drug

Maybe this accounts for all those nice people you meet...

NEW YORK - In 2002, at a Johns Hopkins University laboratory, a business consultant named Dede Osborn took a psychedelic drug as part of a research project.

She felt like she was taking off. She saw colors. Then it felt like her heart was ripping open.

But she called the experience joyful as well as painful, and says that it has helped her to this day.

"I feel more centered in who I am and what I'm doing," said Osborn, now 66, of Providence, R.I. "I don't seem to have those self-doubts like I used to have. I feel much more grounded (and feel that) we are all connected."

Scientists reported Tuesday that when they surveyed volunteers 14 months after they took the drug, most said they were still feeling and behaving better because of the experience.

link to full article

Tuesday, July 01, 2008

The Gates Foundation: Dissatisfied With Results?

An interesting post from In The Pipeline...regarding the Gates Foundation

I guess I always assumed Bill would be just as successful in medicine as his other endeavors...