Comments from Ernst & Young's 2005 Global Biotechnology Report

Key success indicators in 2004 include:

- Biotech raises $16.9 billion in capital in the United States and 2.8 billion euro ($3.4 billion) in Europe, surpassing 2003.
- Successful companies drive investor optimism for the sector, with two biotech companies' valuations rivaling the world's sixth largest pharmaceutical company.
- The sector receives approval for 20 new biotech medicines in the U.S.and 9 in the E.U., compared to 18 and 6, respectively, during 2003.Factoring in new indications, the United States garners 36 approvals in 2004 compared to 35 in 2003.
- The late-stage product pipeline grows considerably in 2004, and the majority of new product approvals in 2005 will come from biotech companies.
- Global revenue increases by 17 percent, sustaining the growth achieved in 2003.
- Biotech hotbeds emerge in the Asia-Pacific region, particularly Japan,India, and China.

U.S. Biotech Comes of Age:
The remarkable surge of new biotechnology products that started in 2003 continued through 2004, demonstrating the strength of the sector's pipeline:
- Biotech companies market approximately 230 drugs, including 13therapeutic antibodies.
- Fifty-five New Drug Applications (NDA) await approval in the UnitedStates alone, including therapies for cancer, congestive heart failure,pain and diabetes.
- Medicines in Phase III clinical trials number 365, compared to 290 the previous year."

Product Success and Strong Financials Drive Biotech Industry's Maturation According to Ernst & Young's 2005 Global Biotechnology Report

Drug groups in talks to hire consultancy to 'spy' on blogs

Several of the world's leading pharmaceutical groups and at least one regulator are in talks about hiring a computer consultancy company that has devised software to "spy" on internet conversations about medicines. The system can seek out, classify and identify thousands of internet messages a day making references to drugs in an attempt to warn companies of potential side effects or gauge positive or negative opinions that could affect their image.

FT.com / Home UK - Drug groups in talks to hire consultancy to 'spy' on blogs

BioBOOM Op/Ed: Ok bring it ON!... now only if they use the info to improve vs. get defensive and blast the nightly news airways with ads and disclaims. Our view is the flatness of growth recently in the pharma supply market is caused somewhat by the fact that the budget process may lean more towards legal and PR lately than research and trials. Must be fun in the annual budget meetings. Just look at the recent announcements on Viagra and blindness, and Vioxx, Tysabri, Avonex, Bextra.....which maybe causing them to overreact. Suggest they start using more genomic and metobolic profiling tools in early research and trials rather than the Joseph Goebbels approach to PR management.

Despite Vow, Drug Makers Still Withhold Data

Pfizer, Merck and GlaxoSmithKline say that they disclose their largest trials, which determine whether a drug will be approved. Though they would not discuss their policies in detail, executives and press representatives at the companies said generally that disclosing too much information about early-stage trials might reveal business or scientific secrets. In contrast, Lilly has registered all but its smallest trials at clinicaltrials.gov. Dr. Breier of Lilly said the company believed that it could protect its intellectual property and still increase the amount of information it released.

Despite Vow, Drug Makers Still Withhold Data - New York Times

Qiagen to Buy artus for $39.2 Million

Qiagen said the acquisition of artus -- which specializes in developing diagnostic kits based on DNA analytical procedures -- will allow it to offer more tests to its diagnostic partners, and strengthen its presence in the field of molecular diagnostic testing.

Qiagen to Buy artus for $39.2 Million

U.S. Braces for West Nile Virus Season

It's sobering news as the nation gears up for a seventh season of the mosquito-borne virus. "West Nile is fading a little bit from the public consciousness," worries Dr. Henry Masur of the National Institutes of Health. "Still, there are more cases of paralysis (from West Nile) than there were in many years of polio." West Nile was long considered a serious problem only for the elderly and frail, and more of a nuisance illness for everyone else. Now a surprising number of patients shows the virus is more threatening than widely believed — and new research finds that even so-called mild cases of West Nile fever can impair people for weeks or months

U.S. Braces for West Nile Virus Season - Yahoo! News

Olympus & Cangen Development of Molecular Diagnostic Test for Lung Cancer

OLYMPUS News Release

Some Viagra users report blindness-Pfizer

The U.S. Food and Drug Administration said it has received about 38 reports of the rare condition among users of Viagra, four reports of blindness among users of Eli Lilly and Co.'s Cialis and one report of the condition in men talking Levitra, made by GlaxoSmithKline Plc.

Some Viagra users report blindness-Pfizer - Yahoo! News

BioBOOM Op/Ed: Well this will send shivers through the sector. Another reason to develop and implement some kind of genetic predispostion or metabolic profiles for any scrip.

US CONGRESS passes embryonic stem cell bill - May 24, 2005

Under the bill, couples who have undergone fertility treatments and have embryos they won't use can then make the choice of putting them up for adoption, giving them directly to another couple, storing them, discarding them or donating them to science. The only federal funds used under the potentially life saving bill are federal funds to then develop those embryonic stem cell lines" donated to science, the Colorado Democrat said.

CNN.com - House passes embryonic stem cell bill - May 24, 2005

BioBOOM Op/Ed: We maybe closing down the blog in order to start a sperm bank... no serious, if we can clone to simply produce stem cell lines, what's the problem dude?

Geron Gets FDA OK to Test Leukemia Drug

The dosing-escalation trial, which the company applied for in April, will establish safe and tolerable doses of the drug and measure the time and magnitude of the drug's ability to inhibit telomerase. Telomerase is an enzyme that allows cells, including cancer cells, to reproduce.


Geron Gets FDA OK to Test Leukemia Drug

Diabetes patients not watching levels

Researchers working with the American Association of Clinical Endocrinologists interviewed 500 patients older than 18 with type 2 diabetes. New York is among a dozen states [Mississippi was highest] with a high percentage of patients who can't properly manage their diabetes. "This is a wake-up call for us to do better," said Dr. Lawrence Blonde, director of the Ochsner Diabetes Clinical Research Unit in New Orleans


Newsday.com: Survey: Diabetes patients not watching levels

PreAnalytiX PAXgene(TM) Blood RNA System is Industry's First to Receive 510(K) Clearance From FDA and to Attain CE Mark

The PAXgene Blood RNA system is the first of its class for the collection, storage, and transport of blood and stabilization of intracellular RNA in a closed tube and subsequent isolation and purification of intracellular RNA from whole blood for RT-PCR used in molecular diagnostic testing

PreAnalytiX PAXgene(TM) Blood RNA System is Industry's First to Receive 510(K) Clearance From FDA and to Attain CE Mark

BioBOOM Op/Ed: This one is special to some of us so congratualations to Qiagen and BD. A break through standard for the growing MDx market.

Global drug sales up 6 pct in year to March-IMS

Drug sales growth has slowed markedly around the world in recent years, hit by generic competition to branded medicines and government curbs on healthcare spending. A few years ago, drugmakers saw double-digit growth as standard. The single largest drug class was cholesterol-lowering medicines, selling $27 billion and showing a growth rate of 10.9 percent. Pfizer Inc.'s Lipitor remained the world's best-selling drug, with sales of $10.8 billion.


Top News Article | Reuters.com

BioBOOM Op/Ed: Any questions on what is happeing to their budgets?

Early Herceptin Use a Breast Cancer Breakthrough

Last month, the National Cancer Institute announced that the drug cuts recurrences in half when given with chemotherapy to women with early-stage disease. On Monday, researchers released more details of their findings to thunderous applause from thousands of cancer specialists attending the annual meeting of the American Society of Clinical Oncology, held in Orlando. "The results were spectacular," said Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society. "I don't think anyone left the room with any doubt this is the new standard of care."

Yahoo! Health News: Early Herceptin Use a Breast Cancer Breakthrough

BioBOOM Op/ED: This is a huge win for biotech and Genetech in particular. After the recent poor press for the Vioxx and Tysabri disaster, we may see a more positive shift in both public attitude and money flow towards the industry if this kind of news and DATA keeps coming.

Personalized Medicine Coalition (PMC) - about PMC

The Personalized Medicine Coalition (PMC) is an independent, non-profit group that works to advance the understanding and adoption of personalized medicine for the ultimate benefit of patients. Our diverse members work together to educate opinion leaders and the public about the issues that will shape how personalized medicine develops — and how quickly all of us can benefit from it.

Personalized Medicine Coalition (PMC) - about PMC

Gates Tells WHO He'll Donate $250M More

"Our foundation launched the Grand Challenges in Global Health in 2003 to get the world's top scientific minds to take on the world's deadliest diseases,'' Gates told the opening of the annual assembly of the 192-nation World Health Organization. Scientists from more than 80 countries sent in thousands of pages of ideas, he said. Ideas included vaccines that don't need refrigeration, easy-to-use devices to detect life-threatening fevers and drugs that attack diseases hiding from the immune system. "We were so taken with the response that we increased our commitment to this research from $200 million to $450 million,'' Gates said.


Gates Tells WHO He'll Donate $250M More

BioBOOM Op/Ed: Follow the money and this is alot!

Celegene's Revlimid Effect on Cancer Stuns Doctors

Specialists said Revlimid, from Celgene, now looks like a breakthrough and the first effective treatment for many people with myelodysplastic syndrome, or MDS, which is even more common than leukemia. The big surprise was that signs of the genetic mutation fueling the disease diminished in 81 patients and vanished in 51. The chromosome abnormality, a rare blood malignancy called 5q- syndrome, completely disappeared, something we've never seen before" from a drug aimed just at boosting red blood cells,

Celegene's stock was up over 7% today following the news at the time we posted this report.

Drug's Effect on Cancer Stuns Doctors - Yahoo! News: "

New Outbreak of Deadly Ebola Virus Is Feared in Congo Republic

The latest outbreak is taking place as the Congo Republic's southern neighbor, Angola, battles an epidemic of Marburg virus, a hemorrhagic fever closely related to Ebola. So far, 280 people have died in that epidemic, which has yet to be contained eight weeks after the virus was first identified. "We don't have lab confirmation yet," Dick Thompson, the medical officer for the World Health Organization, said Friday in a telephone interview from Geneva. "But it has all the features of an Ebola outbreak."The deaths occurred between April 27 and May 11 in Etoumbi and in Mbomo, a town 440 miles north of the capital, Brazzaville, and the site of a previous Ebola outbreak in late 2003. Mr. Thompson said the first victims were hunters who probably had come in contact with dead monkeys in the bush. The Marburg epidemic in Angola has proved particularly hard to contain. Typically, international medical experts who had spent eight weeks battling an epidemic of hemorrhagic fever would be preparing to leave the remaining work in the hands of local and national authorities, according to Mr. Thompson. But the World Health Organization has no plans yet to withdraw its team of more than 20 people from Uíge, the northern Angola province that is the center of the outbreak.


New Outbreak of Deadly Ebola Virus Is Feared in Congo Republic - New York Times

Genomic Tools Identify Profiles of Gene Activity Underlying Cancer

We are just beginning to see the predictive value of gene expression data that reflects gene activity in determining how a tumor will fare under a particular therapy,' said study co-author Mike West, Ph.D., Arts & Sciences professor of statistics and decision sciences at Duke University. This new study focuses on specific gene networks known to contribute to a wide variety of human cancers including those of the breast, lung, and colon. The team analyzed information from microarrays to explore changes in the activity of genes and identify clusters of genes, which the Duke team has dubbed metagenes, whose increase or decrease in mRNA levels differed between normal cells and those with increased activity in particular cancer-related genes. These metagene profiles were then used in a statistical model to predict the activity of other genes controlled by the oncogenes. They found that their genetic model accurately identified cells in which the pathways were active.


Home > > Aging Articles > Cancer > Genomic Tools Identify Profiles of Gene Activity Underlying Cancer:

NOVEL STEM CELL TRIAL IN HEART FAILURE PATIENTS TO BEGIN

The University of Pittsburg is beginning a clinical trial to evaluate the safety and feasibility of a potential treatment for congestive heart failure that involves injecting a patient’s own bone marrow-derived stem cells directly into the heart muscle. The procedure is expected to be performed in five to 10 patients who are scheduled to receive a heart assist device as a bridge to organ transplantation.

More on the Story:
News- Cardiac StemCell Trial

Cancer Drugs Attack Tumors in Many Ways (from ASCO meeting)

At American Society for Clinical Oncology, a cancer meeting Friday, doctors reported that one of Pfizer's new multitasking drugs shrank tumors in 40 percent of people with advanced kidney cancer . Current treatments do that in only about 1 out of 10 cases. Some patients have been on the experimental drug for more than a year far longer than they'd been expected to live.Kurt Bonham is one. The California accountant was only 49 when he was diagnosed with kidney cancer that had already spread to his lungs. 'I'd been given my death sentence,' he said. Now, 13 large masses in his lungs have been reduced to specks. If I can have five more years, I think that they can come up with something fandangled that will either cure the cancer or manage it,' he said."

Cancer Drugs Attack Tumors in Many Ways - Yahoo! News:

Uncertainties Dominate Flu Vaccine Summit

Uncertainties over vaccine supply and demand dominated a two-day brainstorming session for the upcoming flu season, where public health officials and manufacturers discussed ways to avoid a crisis like last year's shortage. Even that best-case scenario wouldn't protect the more than 180 million at-risk Americans for whom flu shots are recommended, but it would be an improvement over the 61 million shots available this past season.

ABC News: Uncertainties Dominate Flu Vaccine Summit

France sets up agency for medical bioethics

France inaugurated a specialised agency for approving research on embryonic stem cells and vetting organ donations and other bioethics issues.The creation of the Biomedicine Agency follows up on a new law, approved by parliament last August and due to take effect this month. The Agency for Biomedicine will also be in charge of authorising screening of IVF embryos that are selected to be free of inherited disease and which are destined, after birth, for providing bone marrow or other replaceable tissue for sick siblings.

France sets up agency for medical bioethics - Yahoo! News

Hospital Bill Could Resrict Specialty Hospitals Change DRG's

The hospital industry is cautiously eyeing legislation introduced yesterday by Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Mont.) that would place considerable restrictions on the burgeoning specialty-hospital sector while altering Medicare payments to all hospitals. A moratorium on new specialty hospitals was established by the Medicare Modernization Act of 2003 in response to concerns that facilities providing specialized care — such as heart or orthopedic surgery — were siphoning off patients from community hospitals. The moratorium is slated to expire June 8. Although a new moratorium would represent a victory for large hospitals, the sector may not be enthusiastic about the changes to components of the payment system called “diagnosis-related groups,” or DRGs, that determine how much a hospital is paid for each service performed. The bill would update the DRGs every five years and base them on individual hospital charges rather than the national average. Supporters of changing the payment system contend that the current formula inequitably reimburses for medical services, creating incentives for the creation of hospitals that only provide higher-paying services. This part of the Grassley-Baucus bill is based on the recommendations of MedPAC.

Long-awaited hospital bill unveiled

FDA Proposes 'Drug Watch' Web Site

The U.S. Food and Drug Administration on Friday issued guidelines on how it expects a new "Drug Watch" Web page aimed at giving consumers drug-safety information to work. The FDA also released more details on its proposed drug-safety oversight board that would mostly be comprised of FDA employees. The board would discuss emerging drug-safety issues and would be responsible for information posted on the "Drug Watch" Web page.


Smartmoney.com: Breaking News: FDA Proposes 'Drug Watch' Web Site

QIAGEN Announces Supply Agreement With Beckman Coulter, Inc. to Provide Sample Preparation Kits for the Vidiera(TM) NsP Platform

Beckman Coulter intends to market two of QIAGEN's automated sample preparation kits for use with their new Vidiera NsP nucleic acid sample preparation platform.

QIAGEN Announces Supply Agreement With Beckman Coulter, Inc. to Provide Sample Preparation Kits for the Vidiera(TM) NsP Platform

BioBOOM Op/Ed: Ok now what does that multimillion Beckman purchase of Agencourt mean since on April 27 they said it would acquire Agencourt Bioscience Corp., a privately held company that provides genomic services and nucleic acid purification products, for up to $140 million. Maybe this is more a diagnostics move but one has to wonder and certainly companies like Promega and Invitrogen(Dynal) miss out on another potential OEM arrangement because as we see over time in MDx, it looks like the "Q" inside strategy for front end is working.

Tm Bioscience receives FDA clearance for Cystic Fibrosis DNA test

"This clearance establishes Tm as a unique supplier of CF tests to our
rapidly expanding customer base against such competitors as ABI (NYSE:ABI) and
Third Wave (NASDAQ:TWTI)," said Greg Hines, President and CEO of Tm
Bioscience. "The Tag-It(TM) Cystic Fibrosis Kit is the only CF testing system
that has performance characteristics which have been established through
extensive studies reviewed by the FDA. Having the first CF test and second
multiplexed genetic test behind Roche's (RHHBF.PK) AmpliChip CYP450 to be
cleared as an IVD....

Tm Bioscience - Media

Recombinant DNA technology may enable oral, rather than injectable, delivery of protein drugs

Transferrin, a plasma protein found in blood, can be fused with large, protein-based drugs such as granulocyte colony-stimulating factor (G-CSF) to create a new oral compound that is capable of surviving the journey through the gastrointestinal (GI) tract and then able to cross over into the bloodstream to be used by the body, according to research from the University of Southern California School of Pharmacy.

Recombinant DNA technology may enable oral, rather than injectable, delivery of protein drugs

San Francisco named HQ for California Sem Cell Agency

California's $3 billion stem cell agency named San Francisco as its permanent headquarters Friday, a designation the city expects will bring it scientific prestige while boosting its economy. "There is no question it will be an anchor for business," Mayor Gavin Newsom said during a news conference after the vote. "This secures our future as a point of destination for discovery."

San Francisco named HQ for stem cell agency

BioBOOM Op/Ed: In another anouncement Mayor Gavin who, also started the controversial gay marriage policy in San Francisco is planning to allow research laboratory mice to marry since they were counted as potential regional biotech employees in SF's submission papers to the stem cell site selection committee.... Just kidding...

Proprietary Research Reveals: Metabolic Syndrome - 'The Costliest Condition You've Never Heard Of' Afflicts Nearly One in Four Americans

Individually, hypertension, diabetes, and obesity are taking a toll on Americans' health. But according to a new analysis, the prevalence of metabolic syndrome -- a condition characterized by a combination of these and/or other risk factors -- is rapidly becoming one of the nation's costliest health concerns. "Metabolic syndrome, and its components -- diabetes and pre-diabetes, obesity, hypertension, and abnormal lipids -- will likely become the major public health problems we face in the 21st century," said Dr. David M. Nathan, professor of medicine at Harvard Medical School and director of the Diabetes Center at Massachusetts General Hospital. "Its long-term consequences, including heart disease, stroke, and the other complications of diabetes, can be reduced with aggressive treatment of risk factors, but at a substantial cost. Lifestyle approaches should also decrease metabolic syndrome and its long-term health and economic costs."

Proprietary Research Reveals: Metabolic Syndrome - 'The Costliest Condition You've Never Heard Of' Afflicts Nearly One in Four Americans

BioBOOM Op/Ed: One more reason we believe the recent approval of Amylin's Byetta will be huge.... how about a Byetta - Lipitor cocktail? Better yet watch what your eating and start to exersize America!

How Leukemia Develops After Cancer Treatment

Chemotherapy drugs can lead to a particular type of leukemia several years after cancer treatment. The leukemia, called acute promyelocytic leukemia, represents about one-fifth of all leukemias that develop after chemotherapy. Promyelocytic leukemia always has a translocation between chromosomes 15 and 17 that seems to cause the leukemia

Yahoo! Health News: Researchers Show How Leukemia Develops After Cancer Treatment

BioBOOM Op/Ed: This maybe news to the public but it's been well known by cytogenetists for some time. What would you expect after we put draino in someone's blood system.

Merck's Gilmartin steps down, Clark in

Merck & Co. said Thursday that Raymond V. Gilmartin is stepping down effective immediately from the top leadership spots at the drugmaker which has been under pressure since recalling its blockbuster painkiller Vioxx last fall


Merck's Gilmartin steps down, Clark in

Gene Variants Predict Bleeding after Heart Surgery

Duke University Medical Center researchers have found that the presence of specific variants of genes that control clotting and the contractility, or "tone," of blood vessels can double the ability of physicians to predict those heart surgery patients at greatest risk of bleeding after surgery. While larger studies are needed to investigate the genetic associations we have uncovered, if our observations are confirmed, genetic screening could become an important part of our pre-operative evaluation of heart surgery patients," said Duke anesthesiologist Ian Welsby, M.D., lead author of a study to be published in the June edition of the Journal of Thrombosis and Haemostasis but appearing early on-line.

|| DukeMedNews || Gene Variants Predict Bleeding after Heart Surgery

NPR : Improving Gene Chips

A new study offers suggestions on how researchers can improve "gene chips" -- devices that allow scientists to see which genes are involved in certain diseases -- and get genomic medicine back on track. Turning the sequencing of the human genome into useful medical breakthroughs depends, in part, on these chips, which so far haven't worked as well as some hoped.

NPR : Improving Gene Chips

BD Announces Acquisition of Protein Separation Technology From FFE Weber GmbH

The need to improve and eventually standardize the preanalytical process leading to protein analytics is significant," said William Kozy, President, BD Diagnostics. "The inherent complexity and dynamic range of proteins within a human plasma sample make it difficult to detect the very low abundance proteins that may prove indicative of a disease state. New techniques for both clinical sample collection and processing are needed. This novel protein separation technology we have acquired from FFE Weber GmbH provides an important preanalytical separation step that will help proteomics researchers to find, characterize and validate new classes of biomarkers."

BD Announces Acquisition of Protein Separation Technology From FFE Weber GmbH

Infertility molecule identified by Scripps research scientists

Scientists at The Scripps Research Institute are reporting that mice created to lack a certain type of molecule known as an LPA receptor have fertility problems, which suggests that these receptors play a major role in conception.

Infertility molecule identified by Scripps research scientists

Value in Drug Stocks?

Friends at Motley Fool putting forth the idea that value investors may want to take a look at the drug industry while searching for dirt-cheap stocks.

Read on: who what when where why how.....

Value in Drug Stocks? [Fool.com: Commentary] April 29, 2005

US - Reproductive 'tourism' .... Babies "R" Us?

"the USA dubbed the Wild West of reproductive technology by bioethicist Arthur Caplan there's an abundance of egg donors who set their own fees as well as a plethora of IVF clinics in many states, which makes pregnancy for even the postmenopausal a possibility. About 50% of IVF procedures using fresh embryos from donor eggs in 2002 resulted in a live birth, according to the Centers for Disease Control and Prevention. Costs including drugs, IVF and donor compensation start at around $20,000 and vary widely from clinic to clinic."

Five years ago, 16% of donor-egg recipients who came to the Center for Fertility and Reproductive Endocrinology at Virginia Mason Medical Center in Seattle were Canadian. Today, it's 33%. Couples from abroad, typically Australia and the U.K., account for about 10 of the 100 couples each year assisted by Tiny Treasures, a Somerville, Mass.-based egg donation agency. Three years ago, just one or two clients weren't from the USA.


USATODAY.com - Reproductive 'tourism':

Why doctors prescribe off label

Although many patients are unaware of it, physicians often prescribe drugs for a disease, or at a dose, or for a patient type that's different from what the FDA has sanctioned. Although off-label prescribing is a legal and common practice, the evidence supporting these treatments can vary widely in quality.


READ MORE:

Why doctors prescribe off label

Hospital Errors Jeopardize Angola Virus Battle

The outbreak in Angola, the largest on record, has killed 255 of the 275 people known to be infected. The epidemic was identified on March 21, but is believed to have started weeks or months earlier.

The New York Times > Health > Hospital Errors Jeopardize Angola Virus Battle

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