Dear Readers, A bill outlawing discrimination based on genetic test results won approval from the US Senate to become a law in April. The Genetic Information Nondiscrimination Act would forbid insurance companies from denying coverage to workers due to a person’s genetic makeup. It would also prohibit insurers and employers from forcing employees to undergo genetic tests. This was a much needed law and protection for the consumers, since as the technology is progressing at high speed and many opportunistic companies wanting to make a quick buck from decoding the personal genome are springing in every street corner. Last month many states, including New York and California, sent warning letters to six of the online gene testing companies informing them, that by performing genetic tests without a doctor’s prescription or authorization, they are on the wrong side of the law. In a time where a large number of Americans can’t afford basic health insurance, it is sad to see companies offering unregulated, unreliable genetic information through web portals. Perhaps it is a good recreation for consumers who have few thousand extra dollars to play with-but these online tests are not for people seeking serious medical information.
We also hope that these unregulated online gene testing companies do not tarnish the image of the promising field of Personalized Medicine and Pharmacogenomics. The field of Pharmacogenomics will play a key role in refining the drug discovery and development process and allow for improved drug safety. In this issue of MedicineandBiotech.com, we bring to you FDA’s recent guidance for industry for Pharmacogenomics to ensure uniform integration in the growing promising field of Pharmacogenomics.
MedicineandBiotech.com continues to strive to provide our readers with valuable information in the Biotech and Pharma world every month. Visit MedicineandBiotech.com regularly to learn more about these developments- by Neerja Sethi, PhD, Managing Editor
"MedicineandBiotech.com is a Unique e-magazine that Provides a Platform where Biotechnology, Medicine, Business sector and the Community Converge"
MedicineandBiotech.com Receives Excellent Ratings as “Best of the Web” for the Second Time by Genetic Engineering and Biotechnology News. Read Dr. Kevin Ahern’s review at http://www.genengnews.com/bestofweb/list.aspx?iid=85
Snapshot of Weekly Biotechnology and Pharmaceutical Headline News at MedicineandBiotech.com......Read in Detail Here
April 22-April 30, 2008
Senate Votes to Ban Discrimination based on Genetic Test
FDA Approves Cimzia to Treat Crohn's Disease
Novartis Announces 20% Average Reduction in Price of Malaria Drug Coartem® to Accelerate Access in Malaria-Endemic Regions
States, including New York and California, Crackdown on Unregulated Online DNA Testing Companies 23andMe and Navigenics-these Tests are not Approved nor Supervised by a Medical Doctor or FDA
DEFINITIONS FOR GENOMIC BIOMARKERS, PHARMACOGENOMICS, PHARMACOGENETICS, GENOMIC DATA AND SAMPLE CODING CATEGORIES
-Pharmacogenomics and pharmacogenetics have the potential to improve the discovery, development, and use of medicines-
This new FDA guidance is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the International Conference on Harmonisation (ICH).Read More.....
Researchers at UT Southwestern Medical Center have developed a simple and inexpensive method to screen small synthetic molecules and pull out a handful that might treat cancer and other diseases less expensively than current methods. In one screen of more than 300,000 such molecules, called Peptoids, the new technique quickly singled out five promising candidates that mimicked an antibody already on the market for treating cancer. One of the compounds blocked the growth of human tumors in a mouse model. Peptoids are designed in the laboratory to resemble chains of natural molecules called peptides.
- Vaccine for new strain of virus broadens government readiness program -
April 28, 2008. Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that the U.S. Department of Health and Human Services (HHS) has accepted H5N1 bulk vaccine antigen to produce approximately 38.5 million doses of vaccine to protect against a new strain of avian influenza. Sanofi Pasteur has a multi-year contract with HHS as part of its pandemic program, and will receive a payment of $192.5 million booked in the second quarter of 2008 for acceptance of the bulk vaccine lot. Read More....
The Friedrich Miescher Institute of the Novartis Research Foundation (FMI) announces a breakthrough technique that restores light sensitivity to previously unresponsive retinas. Study published in the April 27 online issue of Nature Neuroscience shows that the new technique enabled blind mice to successfully perform visually guided behavioral tasks, an unprecedented result that opens the way for clinical trials in humans. The approach pioneered at FMI could be an alternative to surgical transplantation of electrode arrays for the millions affected by blindness as a result of retinitis pigmentosa and late-stage macular degeneration. Read More....
With the recent uproar over Baxter's tainted Heparin, which till now has cuased over 81 deaths, more emphasis is now on the drug manufacturing process. It has been established by the FDA that the contaminated Heparin resulted due to improper materials and processes used in an unispected Chinese plant used by Baxter. With 80% of drugs being manufactured overseas, FDA is now gearing up to improve safety procedures and surveillance in foreign drug manfacturing plants. Here is the statement of FDA Commissioner to the subcommittee on oversight and investigations. It covers the follwing topics and many more:
* 21st Century Challenges to our Drug Delivery System
* Maximizing Foreign Prescription Drug Pre-Approval Inspections
GlaxoSmithKline and Sirtris Pharmaceuticals Incorporated announced that they have entered into a definitive agreement pursuant to which GlaxoSmithKline will acquire Sirtris Pharmaceuticals for approximately USD720 million (or approx. GBP362 million) through a cash tender offer of USD22.50 (or approx. GBP11.33) per share. Through the acquisition of Sirtris, GSK will significantly enhance its metabolic, neurology, immunology and inflammation research efforts by establishing a presence in the field of sirtuins, a recently-discovered class of enzymes that are believed to be involved in the ageing process.
AstraZeneca announced submission of a supplemental New Drug Application (sNDA) to FDA to seek approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
The sNDA submission is based on results from two pivotal efficacy and safety trials with SYMBICORT pressurised meter dose inhaler (pMDI). Read More....
--What are the greatest challenges we face as we age? Will our health care and lifestyle improve?—
This unique conference will explore cutting-edge innovations in the medical, consumer and lifestyle fields that help people live better longer. Key Issues to be discussed at the Conference are:
* Leveraging the Power of Technological Innovations
* The Operating Room of the Future
* The Future of Health Care
* Connectivity and Mobility for the Older Consumer
-This guide offers the consumers descriptions of some of the drug safety terms commonly used by FDA throughout the life cycle of a drug-
The Food and Drug Administration (FDA) approves a drug for marketing after determining that the drug's benefits of use outweigh the risks for the condition that the drug will treat. But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population. This guide covers the following terms and many more...
Pre-Clinical Data, New Drug Approval Process, Adverse Drug Reaction, Consumer Medication Information (CMI), Prescription Drug Labeling, Nonprescription Drug Label ("Drug Facts"), Boxed Warning, Adverse Event Reporting System (AERS), MedWatch, Drug Recall, Drug Withdrawal, etc.
Agilewaves, Inc., leading provider of conservation technology solutions, announced the deployment of its flagship product, the Resource Monitor™ into the Pre K-8 independent NuevaSchool, in Hillsborough, CA. The system is the most in-depth monitoring device ever installed in a school and will be used to measure and display both standard utilities (gas, electricity and water), and the impact of innovative green architectural systems on the buildings’ overall carbon footprint. Read More....
IN THE NEWS
First Compact Heart Assist Device, Thoratec HeartMate II Left Ventricular Assist System, to Support Weakened Heart....Read More
New Coronary Artery Plaque Imaging Device....Read More
Leading developer of RNA interference (RNAi)-based therapeutics Benitec Collaborates with City of Hope in California on HIV/AIDS Lymphoma Therapeutics....Read More
Gloves made from New Type of Natural Rubber Latex, Guayule Latex to Avoid Skin Allergies....Read More
Malaria: Strong Partnerships Aiming to Benefit Patients in Africa....Read More
MAY 2008, MedicineandBiotech.com
YOUR HEALTH
ENVIRONMENT