Scientists Cite Success in Vaccine Hunt

It's a gene-searching technique that goes by the humble name "multiple genome screen." But the research, led by Chiron Corp., elicited a "wow" from the government's infectious disease chief. "It opens up a new arena" in developing vaccines against multiple strains of diseases, said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases. "This is a very, very elegant, potentially usable avenue to go after that whole concept of universal vaccines."

Scientists Cite Success in Vaccine Hunt - Yahoo! News


BioBOOM Op/Ed: Need to follow this development at Chiron closely as it seems it might be a major breakthrough. More exciting, the genetic-screening technique may help develop vaccines against a variety of microbes where multiple-strain protection is a roadblock, said Fauci, whose National Institutes of Health division helped fund the research.

China - Scientists Map Genetic on-off Switches in Human Genome

A new step to decode information in the human genome, scientists have discovered the location and sequence of over ten thousand DNA regions that function as genetic on-off switches in human fibroblast cells. In this study, the researchers also developed an efficient method to identify thousands of regulatory sequences in deferent cells, according to a paper published Wednesday in the online version of the journal Nature.

READ MORE:
Xinhua - English

Test reveals gender early in pregnancy Ethicists fear use in sex selection

Scientific work on fetal DNA analysis has been racing ahead since the late 1990s, when researchers first discovered, to their amazement, that in a pregnant woman's blood, some ''cell-free" DNA -- DNA that is floating around in clumps rather than contained in the nucleus of a cell -- comes from the fetus. The fetal DNA is believed to get into the mother's blood through the barrier of the placenta. The test includes a finger-prick kit for collecting a blood specimen, which is then sent to the lab for analysis. The lab amplifies the DNA and then looks for the presence of a Y chromosome, which only males have. Presence of the chromosome generally means the fetus must be male; its absence means a female

Test reveals gender early in pregnancy Ethicists fear use in sex selection - The Boston Globe - Boston.com - Women's Health - Your Life

BioBOOM Op/Ed: Boy's R Us? Best use for technology will be for Down's syndrome or other genetic diseases. Despite the concerns of a bias towards male selection it's ironic that a number of the feared problems that could be inherited are more male related. Therefore "enlighted" expecting parents might be better off hoping for a female child. Well that's what my daughter will tell me. All this comes down to education. Lets not shoot the messenger or the technology but rather educate the misguided. Some people just want to know so they can decide a paint color for the nursery.

Imprinted genes offer key to some diseases - GENE SILENCING

The ink is barely dry on the human genome project, but already researchers are onto the 'second genetic code,' or the pattern of silencers on our DNA. Using a technology called MethylScope ('methyl' is the DNA silencer), 'we will map this second genetic code to see which genes are imprinted and identify any differences between normal and cancerous cells,' says Nathan Lakey, chief executive of Orion Genomics, a closely held biotechnology concern. Those differences may become the foundation for molecular diagnostic tests within three years, perhaps starting with colon cancer. Normally, the copy of a gene called IGF2 that you get from dad is active, the copy from mom silenced. In 10 percent of us, though, mom's copy has thrown off the silencer, leading to a greater risk of colorectal cancer. Detecting that unsilencing could provide an early warning of the disease.

Science Journal: Imprinted genes offer key to some diseases

DNA constraints control structure of attached macromolecules

A new method for manipulating macromolecules has been developed by researchers at the University of Illinois at Urbana-Champaign. The technique uses double-stranded DNA to direct the behavior of other molecules. of manipulating DNA alone into such shapes, the researchers are using DNA to control the folding and resulting structure of RNA. Eventually, they envision building supramolecular machines whose inner workings are governed by twisted strands of DNA.

DNA constraints control structure of attached macromolecules

New Case of Mad Cow Spurs Talk of Tracking = DNA Database?

Who's your Cow Daddy?

The government is still trying to pinpoint the herd of the infected cow, a "downer" that could not walk and was at least 8 years old. The Agriculture Department, which confirmed the new case on Friday, is using DNA analysis because the cow's breed was mislabeled and its tissues got mixed with parts from other cows.

New Case of Mad Cow Spurs Talk of Tracking - Yahoo! News

Textbook explanation of mRNA translation may need rethinking

Textbook explanation of mRNA translation may need rethinking

Ciphergen to Collaborate With Bayer = THERANOSTICS?

Using its proprietary technology, Ciphergen said it will analyze patient samples from Phase II trials, identify biomarkers that could predict response to an experimental Bayer compound. The test could be used for a possible cancer study, Ciphergen said.

Ciphergen to Collaborate With Bayer

BioBOOM Op Ed: We like the concept, too bad Ciphergen seems to be in the dumpster. Look for more of these alliances that link early diagnostics with the clinical trial efforts of Pharma/Biotech. Personalized medicine is coming, whether patients demand it or litigation will say it should have been done, after the fact.

Group Estimates Potential Flu Death Toll at 500K

More than a half-million people could die and more than 2.3 million could be hospitalized if a moderately severe strain of pandemic flu virus hits the United States, a research group said Friday. The report from the Trust for America's Health assumes that 25 percent of a country's population would become infected if a strain of avian flu became highly contagious and humans had no natural immunity against it. The researchers also assumed the severity of the strain would fall about midway between the pandemic of 1918 and the pandemic of 1968. The group estimated that the federal government has ordered 5.3 million courses of Tamiflu for the stockpile, but that it would require about 70 million doses to cover 25 percent of the U.S. population, which is the rate the World Health Organization has recommended.

Group Estimates Potential Flu Death Toll

BioBOOM Op/Ed: This wouldn't be pretty. Makes Hitchcock's - "The Birds" look like a child's story. More pressure on the industry to step up to the plate for vaccine production and certainly will cause more political posturing in the corridors of the Capitol. Just hope some are willing to act.

Birth From Frozen Ovarian Tissue Reported

A 28-year-old woman gave birth to a healthy baby girl after an ovarian tissue transplant reversed infertility caused by cancer treatment, doctors in Israel are reporting. Doctors froze ovarian tissue from the woman before she had high doses of drugs for non-Hodgkin's lymphoma. Two years later, lab tests showed she remained infertile. Strips of her frozen tissue were attached to her left ovary and fragments of it were injected into the right one

Birth From Frozen Ovarian Tissue Reported - Yahoo! News

A 1st Step to personalized medicine - but controversial

The Food and Drug Administration yesterday approved the controversial drug BiDil to treat heart failure specifically in black patients, marking the first time a medication has been targeted at a racial group. The agency said the approval marked "a step toward the promise of personalized medicine," and was based on research that found the drug could significantly improve the quality of life for black heart disease patients and markedly reduce their chances of being hospitalized and dying.

FDA Approves Controversial Heart Medication for Blacks

BioBOOM Op/Ed: Although we would rather see the approval based on genetic or metabolic profiles not "race", we do feel it's a step in the right direction for more targeted medicines. The data is there but also the risk of implied discrimination according to some quoted in the article
.

New Study Shows Embryonic Stem Cell Lines Classified by ``MicroRNA'' Expression

Results may have implications in determining optimal stem cell lines for therapeutic research. Increasing evidence indicates miRNAs, a recently discovered class of small RNA molecules, play a powerful gene regulatory role in cell differentiation and developmental biology, cancer, and other diseases. "The different microRNA expression profiles in embryonic stem cells suggest some embryonic cell cultures may contain variable subpopulations of spontaneously differentiated cells," said William M. Strauss, Ph.D.

New Study Shows Embryonic Stem Cell Lines Classified by ``MicroRNA'' Expression:

BioBOOM Op/Ed: Someone asked us, while in the hallway at Bio2005, what the next big buzz in biotech is - we'll we're here to say it's microRNA. Watch the developments in this area. Just as SNP's got lots of noise and then it seemed siRNA took over the attention of the research market, we think we'll be seeing lots of papers and press on anything relating to microRNA. Those companies and researchers that take the lead in this area could create significant value.

Researchers grow stem cells from human skin

Researchers at Wake Forest University School of Medicine have successfully isolated stem cells from human skin, expanded them in the laboratory and coaxed them into becoming fat, muscle and bone cells. The study, one of the first studies to show the ability of a single adult stem cell to become multiple tissue types, is reported today in Stem Cells and Development. "These cells should provide a valuable resource for tissue repair and for organs as well," said Anthony Atala, M.D., director of the Wake Forest Institute for Regenerative Medicine and senior researcher on the project. "Because these cells are taken from a patient's own skin, there would not be problems with organ or tissue rejection


Researchers grow stem cells from human skin

Pfizer to buy biotech company Vicuron

Many biotechnology companies are trading near annual lows, making them ripe for a takeover. Most large drug companies are each still awash in billions of dollars in cash, some of it repatriated from overseas operations because of recent changes in the U.S. tax code. Pfizer expects a $28 billion windfall in such overseas profits. And big Pharma's cash positions could herald a new wave of similar acquisitions, analysts said. Pfizer itself is sitting on $24 billion in cash and investments and has an annual cash flow of $16 billion. The Vicuron acquisition, which Pfizer hopes to close by the third quarter, will be the third such purchase this year for the company


Pfizer to buy biotech company: "

Applied Biosystems to Cut 250 Jobs

Applera Corp. Applied Biosystems Group, a maker of life sciences research equipment, said Wednesday that it will cut about 250 jobs and record a substantial fourth-quarter charge as it restructures its operations. The unit of Applera Corp. said the layoffs and associated facility closures will cost between $20 million and $22 million in the April-June quarter, before taxes. The job cuts will primarily be in research and development, marketing and operations.

Applied Biosystems to Cut 250 Jobs

BioBOOM Op/Ed: Quite a reduction in force. The shift from genome mapping projects to other business segments (diagnostics or services) and alliances did not happen fast enough here. This is clearly a move that in the end shows poor management, lack of foresight, vision, and planning. Layoffs are easy to do - shifting strategies and retaining are not. We think instrument life cycle, design, and utility is more similar to the car industry... need new models, better time planning and upgrade options. The day after Clinton and Blair did the "genome mapping is done" press conference one could guess this was coming. With all the recruiting for company moves to different states and countries at Bio 2005 maybe relo is an option. Alaska might offer a heck of a tax break to them we're sure. Within 16 months more shake out predicted including buyout and/or divestitures coming (hint hing IVGN). Certainly some senior management deserves to take a hit too as loyalty is under rated here. And if that's true you will see a fall off in customer loyalty too.

Unique genetic profile helps over-45s get pregnant

"Haddassah University Hospital, Jerusalem, Israel, told the conference that his team's work to identify a specific gene expression profile linked to later fertility would help understanding of the ageing process, as well as enabling the development of better treatments for infertility in older patients.

Unique genetic profile helps over-45s get pregnant: "

A.M.A. to Study Effect of Marketing Drugs to Consumers

The A.M.A., with nearly a quarter-million members, is the latest group increasing pressure on the pharmaceutical industry. The Food and Drug Administration has recently raised its surveillance of drug advertising, sending out 13 warning letters this year on advertising-related issues. The United States House of Representatives voted this month to double the F.D.A.'s budget for monitoring the advertising of pharmaceuticals to consumers

A.M.A. to Study Effect of Marketing Drugs to Consumers - New York Times

BioBOOM Op/Ed: Another reaction to the Vioxx, Tysabri and some even say now that Crestor's misleading. If someone is misrepresenting the product or manipulating the data then toss em in the brig! But almost smells like scape goat time to go after some product manager or ad manager. At least they didn't vote to ban adverstising... as today, with the web, we are often more informed on what we would be taking than our own physician. Of course the paradigm shift to more personalized medicine and screening with genomic/proteomic assays would help also. We're also guessing the fast talking voice over actors that have to read the disclaimers or notes concerning the side affects might wanna consider s l o w i ng d o w n. . .

Compugen and Biosite Announce Diagnostic Collaboration

Both companies announced today a collaboration for the development and commercialization of diagnostic products. Under the agreement, Biosite is licensed to develop and commercialize immunoassay based diagnostic products using novel biomarkers discovered by Compugen. Using its genomic platform and other proprietary computational tools, Compugen is expected to provide Biosite with comprehensive data on several gene targets to be nominated by Biosite.

Compugen and Biosite Announce Diagnostic Collaboration

Clinical Data to buy Genaissance

A maker of diagnostic equip for Dr's offices and clinical labs buys gene-analysis tool maker.

Clinical Data to buy Genaissance

Bill Gates to finance Aussie TB research

The deal between the Gates-funded Foundation for Innovative New Diagnostics (FIND) and the Sydney-based Proteome Systems was due to be announced overnight at the international Bio 2005 conference in Philadelphia. It will allow Proteome to fast-track the development of a rapid antigen-based diagnostic test for TB, a disease that is present in one-third of the world's population and kills 2million people a year. The disease is on the march with several new drug-resistant strains. Proteome's test aims to reduce the time taken to detect active TB from 24 hours to just three minutes while at the same time

The Australian: Bill Gates to finance Aussie TB research [June 21, 2005]

BioBOOM Op/Ed: Hey FIND give us a call we got all kinds of ideas and tools for "new diagnostics". Ok - ok, maybe we'll try to find you at one of the evening get togethers. For those attending the Bio 2005 with us in Philly am sure you all will agree that it's #$%^ crowded! Our feet hurt from all the walking and the backpacks are over flowing with literature plus there is some pretty interesting promotional items. If Minnesota would just give us one of those cool fish luer mailboxes in their booth we might consider moving the company there. Never seen so many country or state pavillions splurging tax dollars to encourage companies to move and set up shop in their locations.

Another view on this spending to luer in biotech companies to one's home turf can be read at:

Biotech strategy may be poison pill - Business - Business - theage.com.au

Oh well, like we say, it's the BioBOOM era

Human Embryo Cloned From Immature Eggs

Denmark - Scientists have cloned human embryos for the first time using unripe eggs matured in a dish — a technique that may help cloning become a viable option for growing patients' own replacement tissue to treat diseases

Human Embryo Cloned From Immature Eggs - Yahoo! News

4 Hospitals Test for Spread of TB

Four Massachusetts hospitals are asking thousands of patients and employees to be tested for tuberculosis after learning that a doctor who works at all four institutions has the disease, health officials said

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4 Hospitals Test for Spread of TB - New York Times

BioBOOM Op/Ed: While at the Bio2005 meeting in Philly we read this and are glad the meeting is not in Boston

Some protestors we're sure to run into at Bio 2005 Posted by Hello

Cancer `wonderdrug' passes first test

A potential cancer wonder drug that may be able to tackle a host of different diseases has passed its first clinical test, researchers said on Friday. Preliminary results from an early patient trial indicate that the drug is hitting its targets. Scientists hope the drug, known as 17AAG, can be used to attack cancer cells on numerous fronts.The drug targets a so-called "chaperone" molecule called Hsp90 that helps maintain the structure and function of a wide range of proteins. Some of these are vital for the growth of cancers. By deactivating Hsp90, the drug simultaneously sabotages numerous other molecules critical to cancer. As a result, cancer cells stop growing and die.

Cancer `wonderdrug' passes first test | HEALTH | NEWS | tvnz.co.nz

Scientists make blood from human stem cells

Australian scientists say they have found a way to make blood cells in volume out of human master cells, which could eventually lead to production of safe blood cells for transfusions and organ transplants. Synthetically produced red blood cells would, in theory, overcome the concerns about dangerous infections that can be transmitted from blood donors to patients worldwide. But researchers said it would probably take years for scientists to get to the stage where blood cells could be made in large enough quantities for transfusions.

Top News Article | Reuters.com

DNA-based nanobarcodes

The idea is one of several applications the researchers have found for what they call "dendimer-like DNA," consisting of many short Y-shaped strands of DNA linked together in a treelike structure. The DNA that carries the genetic code in living cells consists of two complementary strands that attach to one another along their length. But Luo's research purposely and completely ignores the DNA's genetic coding properties. He uses DNA, he said, as a "generic instead of a genetic material."

DNA-based nanobarcodes

2 Utah Hospitals to Test Artificial Blood

Thirty-six patients from Utah may be enrolled in the study that will eventually have 720 participants nationwide."A synthetic blood product is something we've been waiting for years," said Van Summers, chief of the West Valley City Fire Department. This potentially break through product called PolyHeme made by Evanston, Illinois-based Northfield Labs has a hemoglobin base and can transport oxygen.

2 Utah Hospitals to Test Artificial Blood

BioArray Solutions of NJ get FDA clearance

(from GenomeWeb news) - BioArray Solutions has received clearance from the FDA for a bead array-based multiplexed immunoassay, the Warren, NJ-based company said today. The 510(k) clearance covers the company's IgG BeadChip test system, an immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens. The test will be used with BioArray's Array Imaging System, AIS 400, which employs a chip format for detection. BioArray Solutions is currently developing other assays for protein and DNA analysis to run on its platform.

BioBOOM Op/Ed: We saw this interesting company at the ASH meeting and wondered how it was dealing with this Luminex or Illumina like process and IP as they were postioning for the clinical diagnostic market. Seems they have now a good regulatory approach with this approval. There are other systems out there coming such as Autogenomics, Ambion Diagnostics, BioRad, Eppendorf, Eragen and others which should also help create more choices for standardized multiplex processing in the clinical market. Plus they present competitive challenges to players such Affy, Third Wave, Nanogen and TM Biosciences

BM - Self-Imposed Ban on Drug Ads

The company said it wanted to give doctors time to understand new products before patients begin asking for them. "We want to make sure that before we start mass media - television, radio and print branded advertising - that physicians have a level of comfort about the treatment and which patients are appropriate for it," Brian Henry, a spokesman for Bristol-Myers, said.

A Self-Imposed Ban on Drug Ads - New York Times

BioBOOM Op/Ed: Sure they will.... ??? Looks to be an interesting position so their detailers can differentiate themselves as a company "above the fray" during the calls to M.D.'s but frankly this is the era of rapid, instant multichannel marketing and communication. In fact, "they" may say they won't advertise to the customer/patient/end user yet we promise you we will continue to see rapid growth in communication especially about drug therapy. People who are sick and looking for cures even follow Phase 1 data now, then THEY write in their blog about it. So it's going to happen anyways. If BM wants to let others control this info - should be fun to watch when someone throws out wrong or disinformation. Suggest whomever is in their marketing dept. wake up, and don't add their own self made barriers to growth/communication including an internal regulatory control above what the governments may put in place. If I am a competitor this is a wonderful present. It's the 21st century in communication and read the book Building Global Biobrands by Simon and Kotler. This move diffentiates though, so like we said will be interesting to watch how they manage it. Communicate but BE HONEST is our rule.

NCI to implement use of genomics/proteomics to test drugs

The National Cancer Institute plans to change the way it tests drugs in an effort to speed life-saving medicines to patients. Drawing on a better understanding of the genes and proteins that fuel cancer growth, scientists hope to run smaller, more focused studies of promising new drugs to save time and money, says James Doroshow, the NCI's director of cancer treatment and diagnosis. Making these changes will cost about $113 million over five years.

Genetics may determine who benefits from cancer drugs

BioBOOM Op/Ed: Great, finally, clinical trial stratification using genomic and proteomic tools.Should narrow down the population and speed up the data analysis. FOCUS FOCUS FOCUS! Only problem is we have a limited number of M.D.'s who would qualify to run them. SO Training, Training, Training or what about a subset of medical Ph.D's?

Drug Patents Don't Bar Rival Research Says Supreme Court

It said drug companies should have more leeway under the FDA exemption to investigate new drugs, not just generics, so long as the studies are "reasonably related" to a future drug application. Legal experts said the ruling is a boon for big drug companies, who will save millions in licensing costs when conducting startup research. It also will promote more drug development in the U.S. rather than being outsourced to foreign countries, which historically have had looser patent protections.

Justice Scalia, writing for the court, said a lower court was wrong to bar automatically early stage research conducted to identify new drugs. Such experiments are OK so long as the drug could not be feasibly be marketed until after a rival's patent expired, he said."The use of patented compounds in preclinical studies is protected," Scalia wrote, in sending the case back to lower court to determine the exact scope of drug companies' rights under federal law


Drug Patents Don't Bar Rival Research - Yahoo! News

BioBOOM Op/Ed Score: Pharma/Biotech 1 Research Tool Companies asking royalties 0. In the end it may mean less off shore use to avoid the patents and maybe more work and less fear of doing the work in the US.

The NIH's Roadmap for Research

Charting the human genome was just the beginning. Now the focus is creating pathways that will lead to practical applications.

READ ON:
Online Extra: The NIH's Roadmap for Research

Insurer Pushes Pill-Splitting Savings

For every patient that chooses to reduce their costs by 50 percent, it would reduce ours and their employer's cost by half of the cost of that prescription as well. The question is how many consumers would be willing to participate. Chopping his Lipitor tablets in half gives Randy Schneider a little thrill. "I kind of chuckle when I do this," said the 41-year-old line worker at a cheese factory. "It's like I'm making good money per minute if you figure it out."

BioBOOM Op/Ed: Well that's thinking outside the box. Hey lets get 4x strength and chop em in quarters. Wonder if Pharma will just counter the trend, reduce size and only sell children's doses so we all have to take 4 to get to adult strength. In the end, what it comes down to we hope, is proper assessment and better diagnostic tools to measure an individual's metabolic uptake and customize formulation to counter potential side affects. Not sure why they use dosage strength based cost instead of just a flat reimbursement for the therapy(drug) regardless of strength. Otherwise let's smuggle in a 10lb pill from Canada and nibble like gerbils once a day. Isn't the production costs the least part of the price calculation and rather the overhead plus early R&D, clin trials and marketing the bigger components? Otherwise we should be paying 5cents ea

Insurer Pushes Pill-Splitting Savings - Yahoo! News

Biotech, FInally

The just published June 13th issue of BusinessWeek has a great article on the industry. The "BioBOOM" is happening and we are now in the golden era of drug discovery. A must read for anyone in the biotech biz

Cancer patients in particular have reaped rewards from biotech. A decade ago there were fewer than 10 oncology drugs in clinical trials, most of them highly toxic chemotherapies. Today over 400 cancer drugs are being tested in humans, and almost all are targeted biotech medicines designed to produce minimal side effects.

Biotechnology has finally come of age. This declaration may bring to mind the hype that has swirled around biotech so many times in the past. But a growing number of scientists and industry executives say today's enthusiasm is based on a new reality: Drugs actually exist. There are 230 medicines and related products created from biotech techniques. Last year alone, the Food & Drug Administration approved 20 biotech drugs, among them treatments for insomnia, multiple sclerosis, severe pain, chronic kidney disease, incontinence, mouth sores, and cancer. The Tufts Center for the Study of Drug Development estimates that at least 50 of 250 biotech drugs currently in late-stage clinical trials should win FDA approval, a success rate almost three times better than the pharma industry standard. "This is all a continuum of discoveries that started in the early 1980s," says Joseph Schlessinger, chairman of the pharmacology department at Yale School of Medicine and a co-founder of Sugen, the company that created Sutent. "We are now in a golden age of drug discovery."

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McKesson sells clinical-trial supply business, McKesson BioServices to Fisher Scientific

McKesson sells unit to Fisher Scientific - 2005-06-09

Newly Approved First-in-Class Treatment for Type 2 Diabetes Is Now Available

BYETTA is the first in a new class of diabetes treatment called incretin mimetics. By mimicking the mechanisms of a naturally occurring human hormone, BYETTA is a diabetes self regulating drug that stays in the blood system, working actively only when blood sugar levels are too high. In clinical trials, BYETTA was shown to help patients regulate blood sugar levels. Most patients in the long-term BYETTA clinical studies also experienced reductions in weight."
Newly Approved First-in-Class Treatment for Type 2 Diabetes Is Now Available: "

Gene therapy holds promise for arthritis

These data demonstrate that it is possible to transfer genes to human joints ... in a safe and acceptable manner," the research team, headed by Christopher H. Evans, an orthopaedic surgeon at Harvard Medical School, said in the online issue of the Proceedings of the National Academy of Sciences. The safety of gene therapy - using a virus or other vector to insert a gene into cells to help correct a disease - has been called into question in recent years due to high-profile cases involving patient deaths or injuries. In the current study the researchers used a vector that was linked to the death of three boys in another case and were keenly aware of the safety concerns surrounding this procedure. They decided to extend their follow-up of patients who received the therapy to five years to minimize the possibility of undetected dangerous side effects. "Because of the critical importance of safety in the application of gene therapy to non-lethal diseases, we delayed publication of these data until a five-year period had passed without clinical or molecular evidence of side-effects," the team wrote

Gene therapy holds promise for arthritis : Sports News ExpressNewsline.com- ExpressNewsline.com

One-third of scientists admit to research violations

A surprising 33 percent confessed to various kinds of misconduct -- such as claiming credit for someone else's work, or changing results because of pressure from a study's sponsor. The survey indicates that the misconduct involves more than a "few bad apples," said the lead author, Brian Martinson

One-third of scientists admit to research violations

BioBOOM Op/Ed: Lets clean up our act out there! Credibility for the Biotech industry is even more important than revenue at this early stage. Without naming names we could suggest a survey of various managers or companies predicting the % would be higher IF they'd be honest. Suggest one adopt the old West Point motto "Don't lie, cheat or steal nor tolerate those who do". Some of us try to but then again we're not ripping up the career path either with those proper ethics, wonder why?

Alnylam Grants Ambion License to Fundamental RNAi Patents for Applications in the Research Products Market

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) a leading RNAi therapeutics company, announced today that it has granted Ambion, Inc. a non-exclusive license to provide research products and services in RNA interference (RNAi) under the Kreutzer-Limmer patent family owned by Alnylam. This patent family covers short interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells. On May 11, 2005, Alnylam announced that the European Patent Office granted a new patent that significantly extended the claims of the original Kreutzer-Limmer patent. These broad new claims cover compositions, uses, and methods for siRNAs, the molecules that mediate RNAi.

About RNA Interference (RNAi)

RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence and regulate such genes selectively through RNAi could provide a means to treat a wide range of human diseases. The discovery of RNAi has been heralded by many as a major breakthrough, and the journal Science named RNAi the top scientific achievement of 2002, as well as one of the top 10 scientific advances of 2003.


Alnylam Grants Ambion License to Fundamental RNAi Patents for Applications in the Research Products Market

ImClone Treatment Is Cleared by Panel

An independent panel verified a clinical trial by ImClone Systems that showed how the drug Erbitux, used in combination with radiation, was more effective in checking the spread of cancerous tumors beyond the head and neck than radiation alone, the company said yesterday.

ImClone Treatment Is Cleared by Panel - New York Times

Setting Up For A Diabetes Squeeze

Here's a great analysis and why we too are LONG on Amylin. It's been amazing to watch a stock go down after 2 FDA appovals but patience will have rewards. But then again who says the market is ever logical

"The fact of the matter is the street is dead wrong on Amylin, and this is buying opportunity if there ever was one," says Kliff. (David Kliff, publisher of Diabetic Investor, recommends buying shares of Amylin). There are 13 million people diagnosed with diabetes in the United States and that 90% to 95% fall into the Type 2 category, which means the Type 2 patient population ranges from 11.7 million to 12.35 million patients." Kliff estimates that 65% to 75% of these patients are using one or more oral medications to control their diabetes, which puts the potential market size for Byetta somewhere around 8.4 million patients. Amylin shares closed Tuesday at $15.05, representing the lowest closing price since late March of 2003. Shares of Amylin are down more than 35% in the past 12 months. With more than 17% of Amylin shares sold short as of May 10, Kliff believes that a huge short squeeze is in the works, with "an easy ten points" added to Amylin's share price in the coming weeks or months

Setting Up For A Diabetes Squeeze - Forbes.com

Guess Canada has same mental illness problem. This dude was carrying chain saw stained with what appeared to be blood, a homemade sword, a hatchet, a knife, and brass knuckles. U.S. customs agents confiscated the weapons, fingerprinted him, and then let him into the United States. Sure make our % go up (see posting below) Posted by Hello

Abstract: Lifetime Prevalence and Age-of-Onset Distributions of DSM-IV Disorders

Conclusions About half of Americans will meet the criteria for a DSM-IV disorder sometime in their life, with first onset usually in childhood or adolescence. Interventions aimed at prevention or early treatment need to focus on youth.

Arch Gen Psychiatry -- Abstract: Lifetime Prevalence and Age-of-Onset Distributions of DSM-IV Disorders in the National Comorbidity Survey Replication, June 2005, Kessler et al. 62 (6): 593

BioBOOM Op/Ed: Sure now we know Americans are #@$% CRAZY! According to this report almost 50%??? will develop some sort of mental illness (Lifetime DSM-IV anxiety, mood, impulse-control, and substance use disorders) and many will not get proper treatment. Talk with you later, we have to go, as Harvey, the Big invisible Rabbit and dear friend, wants us to go out for a drink.

Medical care & benefits crashing GM?

In his speech at the annual meeting, Mr Wagoner repeated the oft-stated fact that $1,500 of the price of every GM vehicle goes towards providing health benefits for current and retired workers and their families—“a significant disadvantage versus our foreign-based competitors,” he noted dryly. But forcing concessions from the unions is sure to prove difficult.

Union-bash or bust? | Economist.com:

Court Says OxyContin Patent Is Invalid

The financial consequence of the decision could be significant for Purdue. Currently, 65 lawsuits have been filed by insurers and others seeking to force the drug maker to disgorge "monopoly," or excessive, profits as a result of the improper patent and the higher prices OxyContin commanded as a result of it. Any damages awarded against Purdue in those cases could be substantial because OxyContin is an expensive drug and because the law allows for a potential tripling of any awards in such cases as a way of penalizing a manufacturer. (That's gotta hurt)


Court Says OxyContin Patent Is Invalid - New York Times

Court backs Pfizer - Cheaper generics withstand lawsuit

Pfizer Inc. and other drug companies have the right to sell unbranded versions of their own drugs even if they undercut sales of generic competitors, a U.S. appeals court ruled. The U.S. Federal Trade Commission, at the urging of three U.S. senators, is looking into whether "authorized generics" are anticompetitive. Under federal law, the first generic-drug maker to challenge patents on a drug wins six months of exclusive marketing rights. Teva argued that Pfizer sought to thwart competition by undermining that incentive


Court backs Pfizer

BioBOOM Op/ed: Does this mean there's your "V" blue pill and soon a no-name white one in a white box for less? Heck we thought resale low prices or what one could call "brand neutral" just was a Canada or Mexico road trip.

New Device Could Shorten Drug Development

Researchers at the Georgia Institute of Technology have developed a device that has the potential to significantly reduce the time needed to analyze these important proteins, shortening development time for new drugs and bringing down the overall cost of protein analysis technology. According to findings published in Applied Physics Letters, the device can potentially analyze proteins much faster, more gently and at a lower cost. (they claim?!!?)

Georgia Institute of Technology :: News Room :: New Device Could Shorten Drug Development

Study: Genes Play Role in Women's Orgasms

A woman's ability to have an orgasm is at least partly determined by her genes and can't be blamed entirely on cultural influences, new research suggests. Specialists say the findings don't mean women who inherit an unfortunate gene package are doomed. They just mean that more work, or patience, is required. The main benefit of discovering the genetic elements of sexual function, experts say, is to help scientists find better treatments for sexual problems. The study was reported this week in Biology Letters, a journal of the Royal Society, Britain's independent academy of science.


Study: Genes Play Role in Women's Orgasms - Yahoo! News

BioBOOM Op/Ed: Ok Ok don't we now know almost everything is gene related? Big market for a test we bet. And reminds us of a joke - A woman went to a doctor and said , doctor, I have a problem. every time I sneeze I have an orgasm. the doctor said, oh really, what have you been doing for it. the woman replied, snorting pepper.

SBA policy may impede VC funded BioTech firms

The Small Business Innovative Research grants from the U.S. Small Business Administration are supposed to help small companies pursue innovative research. But the eligibility rules have recently been reinterpreted by the SBA to eliminate companies that are more than 50 percent backed by venture capitalists if the venture capital firms fund other companies with a total of more than 500 employees

BostonHerald.com - Business: Venture-capital policy impedes stem cell firms

BioBOOM Op/Ed: Well now we're not using VC or SBA money yet. ummmm? Time to apply? This is a problem for those currently estabilshed (might free up some funds perhaps) and it's also a warning for new ventures not to let your venture partners cross that 50% ownership level if you want to apply for any SBIR's. Or at least pick your partners carefully based on their other relationships

New Vaccines Prevent Ebola and Marburg in Monkeys

Two new vaccines, one for Marburg and one for Ebola, were 100 percent effective in a study of 12 macaques being published today in the journal Nature Medicine. Monkeys given just one shot of vaccine and later injected with a high dose of virus did not even get sick. Normally, all the animals would be expected to die


New Vaccines Prevent Ebola and Marburg in Monkeys - New York Times

Invitrogen and ABI set up co-marketing in proteomics

BioBOOM Op/Ed: Invitrogen and ABI announced a co-marketing agreement focused on the Proteomics market while at the American Society of Mass Spectrometry annual meeting in San Antonio (nice touch). What maybe more interesting is the two press releases discribing the effort from the two companies. Look and compare..... why 2 releases? Ok time to look up some guidance on this new marketing trick from Ries and Trout who's teachings we follow. Nope not there, something about consistancy if we recall correctly. Oh well, would have been fun to be in on the discussion between the two marcom groups to get these out. Either way it's a formidable alliance to watch. Of course big relationships bring their own type of expectations and pressures - just ask Ben and J-Lo. If the process has problems in someones lab will we see finger pointing or problems solving?

THIS:

Applied Biosystems and Invitrogen Corporation Form Strategic Alliance to Deliver Advanced Proteomic Solutions for Biomarker Discovery and Validation

OR THIS:

Invitrogen Corporation Expands Proteomics Capabilities with Launch of Mass Spectrometry Solutions and Co-Marketing Agreement with Applied Biosystems:

Stem Cell Advances May Make Moral Issue Moot

In recent months, a number of researchers have begun to assemble intriguing evidence that it is possible to generate embryonic stem cells without having to create or destroy new human embryos. The research is still young and largely unpublished, and in some cases it is limited to animal cells. Scientists doing the work also emphasize their desire to have continued access to human embryos for now. It is largely by analyzing how nature makes stem cells, deep inside days-old embryos, that these researchers are learning how to make the cells themselves


Stem Cell Advances May Make Moral Issue Moot

Amylin issues positive Pramlintide data

Data from a mid-stage clinical trial showed its Pramlintide drug helped obese patients achieve progressive weight loss compared with those taking a placebo. Subjects in the 16 week study lost an average 3.6 percent of their body weight with no evidence of a plateau effect.


Amylin issues positive Pramlintide data - Yahoo! News

Virus Uses Tiny RNA to Evade the Immune System

When scientists found that RNA interference appeared to be a basic and widespread gene regulatory mechanism, “it became clear that such a fundamental pathway could of course be pirated by a virus,” said postdoctoral fellow Adam Grundhoff, co-first author of the paper. Viruses can use the host RNA inference machinery, which is often speculated to have evolved as an antiviral mechanism, to generate small RNAs that serve their own purposes — the latest chapter in the long cat-and-mouse game known to virologists as host-virus coevolution,” the researchers conclude in their Nature article.


HHMI News: Virus Uses Tiny RNA to Evade the Immune System

Researchers identify genetic sensitivity to drug warfarin

The era of personalized medicine promised by the human genome project moved one step closer to reality today, with a University of Washington study that explains why some people are more sensitive than others to a common blood-thinning drug. The researchers found that gene variations determine whether people should get high, medium or low doses of the drug warfarin, also known by the brand name Coumadin. They also found that 90 percent of Asians carry low-dose versions of the genes, while African Americans are more likely to have high-dose versions. Dr. Francis Collins, director of the National Human Genome Research Institute, said the Seattle study is an example of the type of discoveries that should accelerate in coming years, building on the work of the ambitious effort to map the human genetic sequence completed two years ago."This is the kind of thing we have been hoping would start to happen, converting the dreams into reality," Collins said.

The Seattle Times: Health: UW researchers identify genetic sensitivity to drug

Is Hormone Oxytocin 'Trust In A Bottle?'

Swiss and American scientists demonstrate in new experiments with a nasal spray containing the hormone oxytocin. After a few squirts, human subjects were significantly more trusting and willing to invest money with no ironclad promise of a profit.


CBS News | Is Hormone 'Trust In A Bottle?' | June 1, 2005�14:30:10

BioBOOM Op/Ed: Creates an interesting dillema don't ya think? Time to get the old squirty flower lapel on the cars salesman suit. mmmmm Wonder if the air over North Korea needs some seeding. But we bet the Swiss will try to prove the stuff is already in chocolate. There is also some evidence that oxytocin can help prevent breast cancer because it inhibits the growth of breast cancer cells in vitro. A loving, caring touch makes our bodies to release oxytocin, as does nipple stimulation like when baby suckles the breast.(M aybe all these babies who like to play with the one nipple while suckling the other are doing a favor for their mothers!) This might explain in part why breastfeeding and being sexually active lowers a woman's breast cancer risk. Non-breastfeeding women can benefit from oxytocin by rubbing and tweaking their nipples regularly. Ok another thought but not sure our lawyers would appreciate it

Speedy drug-review process 'broken' US Congress wants to take action

Since 1992, companies pledged to complete 91 clinical trials in exchange for the FDA's speediest drug review. Some 42 of the promised studies remain unfinished, including those for such blockbuster drugs as the cancer treatment Gleevec, Markey,Democrat of Malden alleged. Twenty-one of the studies have not been started, while 18 are on or ahead of schedule, according to Markey's research. His office relied on FDA data and did not contact drug companies directly. Under legislation he expects to introduce next week, drug companies could face millions of dollars in fines if patients are harmed because tardy trials keep some health risks from being publicized. The proposed legislation would require drug companies to change the wording on labels to indicate that the safety and efficacy of conditionally approved products have not been proven.

Speedy drug-review process 'broken' - The Boston Globe - Boston.com - Business

BioBOOM Op/Ed: And you wonder why we think the R&D budgets will be tighter with more budgets shifting to legal, PR and regulatory? Seems like some of these companies need a good management shake up. And we don't mean bring on more outside the sector MBA's or finance types, who despite platitudes seem more interested in the bottom line than saving lives. (hint hint: chase the cures,not the revenue and the money will come) We fear the environment they have managed themselves into has shifted the past 5 years from good medicine to greed medicine in the public eye and the reaction we see from the general public, media, and now their reps in congress shouldn't be unexpected. Any strong ethical leadership around in the sector anymore? Fewer and fewer we fear. Because this kind of government intrusion that their mismanagement has caused will also be a problem for investors including the little old lady from Iowa who's 401k was used in hoping to help others

Sequenom names new CEO - Harry Stylli

In a release early Wednesday, Sequenom (SQNM) said that Stylli most recently served as CEO of biotechnology concern Xencor Inc. Stylli will remain a director of Xencor, which is privately-held. He is also a co-founder of Aurora Biosciences

Sequenom names new CEO - Biotechnology - Company Announcements

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