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View Article  Discover-E-Newsletter August 2005
Pharmaceutical Discovery Newsletter
August 2005

Current Issue

RNAi: A Robust Tool for Target Identification and Validation  

By Subrahmanyam Yerramilli, Eric Lader, Dirk Loeffert, Friederike Wilmer, Peter Hahn, Elizabeth Scanlan

The application of RNA interference (RNAi) to mammalian cells has significantly accelerated research in functional genomics and drug discovery. RNAi allows simple, effective, and specific downregulation of mammalian gene expression, making it a powerful and accessible technique with enormous scientific, commercial, and potential therapeutic value.More>>>

In Silico Methods and Predictive Tools Along the Drug Discovery Value Chain 

By Dragan A. Cirovic, Vijay Bhargava, Frank Harrison, Roy Vaz, Abdel Laoui

The emerging drug discovery paradigm emphasizes the concept ofin silico methods for predicting in vitro and in vivo absorption, distribution, metabolism, excretion and toxicological (ADMET) parameters. These methods are being applied as early in the drug discovery value chain as possible to achieve early attrition of unpromising candidate compounds.More>>>

Microarrays on the Spot: Moving Gene Expression Microarray Data to the Clinic–An Analytical Requirements Perspective 

by Thomas Goralski

DNA microarrays are used to measure relative transcript abundance in RNA samples, allowing researchers to identify differences in gene expression. To date gene expression microarrays have predominantly served discovery based research efforts, however, recent technological improvements and standardization initiatives, as well as need driven incentives, have opened the possibility of using this high-complexity analytical test in both pre-clinical and clinical settings.More>>>

Technology Focus: Magnetic Beads Hold the Key to Novel Proteomic Analysis Using Mass Spectrometry 

By Hege Skjellerudsveen

Key to successful scientific research in any discipline is obtaining sufficient sample material. In particular for pharmaceutical research, protein isolation procedures often need to produce samples that have high integrity and concentration. Ideally, such a process would be easy to carry-out and, even more importantly, produce the sample in a format that is readily applicable to the experiment at hand.More>>>

Industry Watch: A Cure for Multiple Sclerosis in Our Lifetime?

By Anthony J. Sinskey, Stan N. Finkelstein, Scott M. Cooper

Practice guidelines for MS in the United States and Canada recommend disease-modifying agents for most patients, but at any given time only 20% are using the drugs.More>>>

Voice of Discovery: Interconnected Signaling Pathways: Rethinking Drug Specificity as a Desirable Objective

By Rangaprasad Sarangarajan, Shireesh Apte

Intracellular signaling occurs through cascades of interconnected/interdependent networks, rather than through linear pathways. Because effector molecules modulating this network typically function in both redundant and pleiotypic fashion, selective modulation of a single intracellular signaling pathway seems highly improbable.More>>>

Issue Preview

Coming up in the September 2005 issue of Pharmaceutical Discovery :

Can Medical Image Analysis Change the Economics of Drug Development?
Advances in medical imaging analysis are shedding new light on disease structure and function over time. The authors examine the potential of imaging biomarkers and other tools to improve the drug discovery and development process at every stage.
Using Mircoarrays to Detect Disease and Tailor Therapy
Modern microarrays can genotype hundreds of thousands of SNPs at a single pass, allowing whole-genome studies of disease genetics and drug response. As costs fall, diagnostic microarrays are migrating from the lab to the clinic, classifying diseases more precisely than ever before and opening the door to personalized medicine.
Microarrays on the Spot: The Importance of Introducing Gene Expression Analysis into Pharmacological Development Discovery by Design: On Predicting Side Effects and the Limitations of Rational Drug Design The Microscale Laboratory: A History of DNA Microarrays


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View Article  Brandeis study: Poor hearing may cause poor memory
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Healthorbit.ca
View Article  Is bigger better in generics?
Lisa Jarvis. Chemical Market Reporter New York:Aug 15-Aug 21, 2005. Vol. 268, Iss. 5, p. 24,26 (2 pp.)

The increasing commoditization of the generics market has companies scrambling to carve out a profit by ramping up their purchasing power and tapping into growth markets abroad, most quickly achieved through mergers & acquisitions (M&A). Teva Pharmaceutical Industries Ltd's recently proposed $7.4 billion acquisition of Ivax Corp underscores the intense competition among generics players and the drive to create massive, global manufacturing and marketing networks. The deal will put Teva back into the leading position in the global generics market, knocking out Sandoz, which overtook Teva a month ago when it closed on its purchases of Hexal AG and Eon Labs. The next wave of M&A may come from US companies looking to globalize their business to tap into higher growth regions. In the absence of complementary M&A targets, some US companies may focus on specialized technologies or niche markets.

Chemical Market Reporter New York
View Article  Politicizing the FDA
OVER A YEAR ago, when the Food and Drug Administration first rejected Barr Laboratories Inc.'s proposal to sell the emergency contraceptive Plan B over the counter, we agreed that the agency had reason to be cautious. Although the drug -- which contains the same ingredients as contraception pills -- had been proved safe and effective, and although studies showed that its availability did not lead to an increase in sexual activity, there was little hard information measuring the drug's impact on young women. Because some drugs do cause different side effects in adolescents and adults, we argued that the agency was within its rights to ask Barr for a new proposal.

Acting on the FDA's suggestions, Barr then submitted a new application, offering to sell its drug over the counter to adults but to require prescriptions for girls younger than 17. Although not all such FDA suggestions result in approvals, there seemed no reason to doubt that this one would. As recently as last March, the FDA commissioner, Lester M. Crawford, implied as much at his confirmation hearing: "The science part is generally done," he said when asked about the approval process for Plan B. "We're just now down to what the label will look like." He also promised two senators, Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.), that a decision would be made. According to some at the agency, drafts of the approval letter were under discussion.

Then, late last Friday afternoon, Mr. Crawford announced that the agency would delay approval once again. Citing "novel regulatory issues" and "profound" policy questions, he said that the new application required further study and public comment.

With this statement, Mr. Crawford not only broke his word to two senators, but he also put the agency at risk of losing its credibility. In recent months critics have accused the FDA -- which is required by law to make decisions exclusively on scientific and legal grounds -- of falling victim to outside political agendas. They have claimed that the Plan B decisions have reflected not sound science and legitimate caution but rather the influence of "moral" and antiabortion lobbies claiming that Plan B, which mainly acts by preventing fertilization, might occasionally act by dislodging an hours-old fertilized egg and therefore "aborting" it. By abruptly rejecting an application that had been tailored to meet the FDA's requirements, Mr. Crawford appears to confirm the critics' worst fears.

We don't deny that there are legal and practical difficulties involved in selling the same drug in the same package to different age groups. But the agency has not only had past experience with restricted over-the-counter sales of nicotine and tobacco, it has also had plenty of time to communicate its concerns to Barr and to negotiate a workable system. Whatever the legal arguments taking place, this unexpected delay at this stage of the approval process makes the FDA -- long admired around the world for its neutrality and professionalism -- look like an easily manipulated political tool.

washingtonpost.com
View Article  How New Heart-Scanning Technology Could Save Your Life
More and more, doctors are diagnosing coronary disease without any invasive tests whatever

Link to Article

time.com
View Article  French Fries and Cancer
There has been a growing body of scientific evidence of a link between French fries and cancer. By Simson Garfinkel

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trblogs.com
View Article  Researchers Describe New Cost-Effective Method To Assess Sleep
 

Brandeis study: Poor hearing may cause poor memory

 

August 30, 2005 -- Brandeis researchers say older people suffering a hearing loss might also lose the ability to remember spoken language.

Full Details

 

Researchers Describe New Cost-Effective Method To Assess Sleep

 

8/29/2005 | BOSTON – Using information hidden in the beat-to-beat changes of the heart’s electrical signals, researchers at Beth Israel Deaconess Medical Center (BIDMC) have developed an inexpensive method to assess the stability and quality of sleep, which could be used to help understand the mechanisms of sleep control and diagnose sleep disorders, as well as to test the efficacy of sleep aids and other medications.

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Healthorbit.ca
View Article  Brain Chemistry and the Placebo Effect
To date all studies of the placebo effect have relied on anecdotal data, viz., qualitative responses as reported by the patient. But a new study that explored brain chemistry.... By David Appell

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trblogs.com
View Article  CDERWEEK 8/22 - 26/2005
[Skip navigation]U.S. Food and Drug AdministrationFDA Logo links to FDA home page
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Date: August 22 - August 26, 2005

August 26, 2005

August 24, 2005

August 23, 2005

  • New and Generic Drug Approvals
    • Alavert (loratadine) orally disintegrating tablets, Wyeth Consumer, Formulation Revision
    • Alphagan P (brimonidine tartrate) ophthalmic solution, Allergan, , Approval
    • Clozapine Tablets, Caraco Pharma, New Strength
    • Copegus (ribavirin) in combo w/Pegasys (peginterferon alfa-2a), Hoffman-La Roche, Labeling Revision
    • Fludeoxyglucose F 18 Injection, North Shore LIJ Research, Approval
    • Micro-K LS Packets (potassium chloride) Extended-release Liquid, KV Pharma, Labeling Revision
    • NEVANAC (nepafenac) ophthalmic suspension, Alcon, Approval
    • Zolpidem Tartrate Tablet, Caraco Pharma, Tentative Approval

August 22, 2005

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View Article  New Guidelines Released For Heat Stress In Youth Football
 

New Guidelines Released For Heat Stress In Youth Football

 

August 18, 2005 | INDIANAPOLIS – New guidelines from the American College of Sports Medicine (ACSM) emphasize fluid replacement and acclimatization to the heat, as well as practice uniform and other modifications in order to reduce the risk for heat exhaustion and exertional heat stroke in young football players.

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Healthorbit.ca