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The U.S. Food and Drug Administration (FDA)’s Nanotechnology Task Force released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.

“Nanotechnology holds enormous potential for use in a vast array of products,” said Commissioner of Food and Drugs Andrew von Eschenbach, M.D., who endorsed the Task Force Report and its recommendations on July 23, 2007. “Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.

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High resolution views of a receptor molecule that is implicated in cancer offer a clear target for the development of a new class of cancer drugs, Yale School of Medicine researchers report July 27 in Cell.

It is also anticipated that the new family of drugs may be applied for the treatment of gastrointestinal stromal tumor (GIST) cancers that are resistant to Gleevec and Sutent. Although these drugs would target the same receptors as Gleevec and Sutent, they would do so by a different mechanism and may therefore be useful for patients who are resistant to these drugs.

“I was surprised to see what the molecules did when they were activated,” said Joseph Schlessinger, professor and chair of pharmacology and senior author of the study. “The arrangement is much simpler and more elegant than I thought.”

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Manhattan Research, a healthcare market research services firm, today announced the leading pharmaceutical product website destinations for physicians from its new physician research study, “ePharma Physician(R) v7.0: The Future of Professional eMarketing.”

Top 10 Pharma Product Websites Among Physicians in 2007 Ranked by Number of U.S. Primary Care Physician Visitors

1. Januvia

2. Singulair

3. Advair

4. Chantix

5. Adderall XR

6. Byetta

7. Gardasil

8. Vytorin

9. Avandia

10. Concerta

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The Business Intelligence firm La Merie S.L. reported that the HMG-CoA-reductase inhibitor atorvastatin remained the no.1 best selling blockbuster drug in 2006 with ww sales of US$ 13.6 bln for Pfizer and Astellas Pharma. Among the TOP 10 blockbuster drugs are four biologics (antibodies and proteins). A total of 114 distinct blockbuster drugs were identified with 2006 sales of more than US$ 1 bln each. Total revenues from sales of all blockbuster drugs in 2006 were US$ 233.7 bln of which 23.1 % were achieved by biologics. The best selling classes of blockbuster drugs were again HMG-Coa-reductase inhibitors of which AstraZeneca’s rosuvastatin showed the highest growth rate with 59 % over the previous year. Among the TOP 10 blockbuster drug classes were three biologics: erythropoietin, anti-TNF and insulin & insulin analogs. Blockbuster drugs were in the product portfolio of 30 biopharmaceutical companies. Pfizer was the leader in the TOP 10 class of blockbuster drug companies with sales of US$ 28.7 bln originating from nine blockbuster drugs. The TOP 10 companies had between four and 12 blockbuster drugs each to generate 2006 sales between US$ 9.4 bln and 28.7 bln per company. These results and more were found in a search conducted by La Merie Business Intelligence and published in a complimentary report on July 6, 2007. The document entitled “Blockbuster Drugs 2006” can be acquired as a free download at La Merie’s News Center and Online Store PipelineReview.com (http://www.pipelinereview.com).

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Now that politics has got in the way of commonsense and led to the demise of the planned joint Australia New Zealand Therapeutic Products Authority, the Government must explain what it is going to do to streamline the approval of pharmaceutical products in New Zealand, says the New Zealand Medical Association.

The proposed joint authority aimed to protect the health and safety of New Zealanders and Australians through the regulation of prescription and non-prescription medicines, complementary medicines, and medical devices.

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CENiMED GmbH, BioTeZ Berlin-Buch GmbH and Invitek Gesellschaft für Biotechnik & Biodesign mbH (company for biotechnology and bio-design) announce their cooperation in the development, production and marketing of Recovery-ELISAs for therapy control of a new group of therapeutics, the so called humanised antibodies.

Humanised antibodies offer unforeseen potentialities in cancer therapy, e. g. for the treatment of mamma carcinoma. Previous therapy control methods, however, could not avoid overdoses which had caused adverse reactions with the patients. Recovery-ELISA (R-ELISA) is an innovative, patented ELISA technique for the determination of the exact efficacy concentration of the therapeutic antibodies and the therapy control. The automation of this technique will be established by a renowned platform manufacturer and then will be made available for the patients and the pharmaceutical industry.

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CENiMED GmbH, the leading provider of pharmacogenomic services in Germany announces its certification according to international Good Laboratory Practice (GLP) standard by the German authorities, Landesamt für Arbeitsschutz, Gesundheitsschutz und technische Sicherheit Berlin (LAGetSi). The certification applies to pharmakogenomic analyses for the in-vitro determination of the genotype and phenotype as well as to gene expression analyses.

Dr. Volker Muschalek, CEO of CENiMED GmbH, states: “This makes CENiMED GmbH the first and only laboratory in Europe which is able to generate pharmacogenomic data accepted by the regulatory agencies (FDA, EMEA). Since years the agencies strongly recommend the submission of pharmacogenomic data for the approval process of new drugs. Apart from that we are very happy that we can now also offer gene expression analyses with Affymetrix technology as the only laboratory in Europe.”

Dr. Dirk Sawitzky, COO of CENiMED GmbH comments: „This certification reflects the successful implementation of highest international quality standards at CENiMED GmbH and is another milestone in the flourishing development of our young company.”

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The San Francisco Chronicle on Sunday examined how biotechnology companies soon could face generic competition under a bipartisan Senate bill (S 1695) proposed by Democrats Edward Kennedy (Mass.) and Hillary Rodham Clinton (N.Y.) and Republicans Orrin Hatch (Utah) and Mike Enzi (Wyo.). Under the legislation, biotech companies would get 12 years of market exclusivity after FDA approval, compared with five years for traditional brand-name medicines.

The Generic Pharmaceutical Association said a 12-year period of market exclusivity is “arbitrary and excessive.” Association CEO Kathleen Jaeger said, “It’s just going to unjustifiably delay access to consumers.”

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The leaders of the biotechnology industry will once again gather for BIO-Europe, the world’s largest stand-alone partnering conference, in Hamburg, Germany (November 12-14). This year’s edition promises to set a new standard for compelling and informative content necessary to discern opportunities in an era of significant biotech industry change. Join many of the most respected thought leaders and decision makers in the industry and examine the issues, new business approaches and policy trends most important to the emerging biotech future.

A central theme to BIO-Europe 2007 will be to understand the signs, symptoms and opportunities of the much-anticipated convergence of biotech and Big Pharma. Fundamental questions, such as how can biotechnology companies help the pharmaceutical industry meet double digit growth expectations by contributing new products and processes, will be openly discussed and debated by some of the most notable names in the industry. A session destined to shake up traditional wisdom and preconceived notions of the industry is entitled, “The Changing World Order of Biotech-Pharma - How Will Emerging Realities Affect Your Business Strategy?”

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The European biotechnology industry welcomes the European Medicines Agency’s (EMEA) new guidance on biosimilar medicines, entitled “Questions and Answers on biosimilar medicines” which was announced recently.

This initiative reinforces the EMEA communication on “biosimilar” medicine and recognises the uniqueness of these products. It states that they cannot be classified as “generics” in the same way that chemical compounds may be, due to the differences stemming from the variability of the active biotechnological substance and its manufacturing process.

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Anticipating the need for patient-friendly technologies that can deliver therapeutic doses of prescribed drugs with minimal reliance on the patient, drug developers continue to explore noninvasive routes of administration. Delivering drugs through the skin - transdermal delivery - possesses several attractive attributes, but as work with passive transdermal patches has progressed, so too has the realization of the true extent of the barrier to drug delivery presented by the stratum corneum, the skin’s outer layer of dead, hydrophobic, keratinized cells. By using a variety of energy and mechanical approaches, active transdermal delivery expands the potential for delivering drugs noninvasively by actively transporting the drug across and through the skin.

Led by established technology companies including Alza/J&J, Becton Dickinson, and 3M, combination microporation drug delivery products will dominate the active transdermal sector for the next three years, representing almost two-thirds of the market in 2009. Other important active transdermal segments include iontophoresis and heat-assisted transdermal products. Products based on electroporation, ultrasound and lasers will also compete for market share.

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ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, launched a new initiative called Product Quality Lifecycle Implementation (PQLI) at its Washington Conference in early June.

In its role as a “catalyst for change” ISPE is working with regulators in the United States, Europe, and Asia-Pacific to help industry find solutions to the challenges in implementing ICH guidances. The goal of these sessions is to begin to define areas where industry will be able to provide the technical framework for the implementation of QbD in regulatory submissions.

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VASTox plc (AIM: VOX), a leading UK biotechnology company, announces that it has entered into a series of pilot screening agreements with major pharmaceutical companies, including Merck KGaA, Johnson & Johnson (Pharmaceutical Research & Development, Belgium) and Servier. Together, the deals are worth in excess of 300,000 euros in service revenues to VASTox during 2007.

VASTox will use its market-leading zebrafish technology platform to blind-screen selections of known compounds for safety and toxicity to validate to its clients how this technology can predict unwanted side effects. It is the Company’s aim to develop these relationships into higher-value, longer-term partnerships.

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- Forecasting key to decision making and business strategies

- Challenges to define forecast measures against diversity in geography and varied time horizons

- Senior Forecasting executives from companies such as Novartis, Nycomed, Solvay and GE Healthcare now signed up to speak at EyeforPharma’s forthcoming Forecasting Excellence Summit.

- The EyeforPharma Pharma Forecasting Excellence Summit USA 2007 will take place in Boston MA, October 25-26th 2007

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The Philadelphia Inquirer on Sunday examined the competition between Merck and GlaxoSmithKline on the development and marketing of human papillomavirus vaccines (Stark, Philadelphia Inquirer, 7/8).

Merck’s HPV vaccine Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains. FDA in June 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC’s Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine, which is given in a three-shot series (Kaiser Daily Women’s Health Policy Report, 6/26).

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The Swiss drug company Novartis announced today that its new product Exelon Patch has been approved by the US Food and Drug Administration (FDA) as the first skin patch for patients with mild to moderate Alzheimer’s disease.

The FDA also approved the product for the treatment of patients with mild to moderate Parkinson’s disease dementia, a distinct and common disorder that affects 20 per cent of people diagnosed with Parkinson’s.

Exelon Patch maintains steady bloodstream levels of the the drug rivastigmine (a cholinesterase inhibitor) for 24 hours via a transdermal patch that is applied to the back, chest or upper arm of the patient.

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Civil law suits were filed in a Montreal court yesterday against Andrew Speaker, the 31 year old lawyer from Atlanta, US, who flew to Europe while infected with a drug resistant strain of TB two months ago.

According to a report from the Associated Press (AP) in Montreal, the plaintiffs are nine people; eight fellow air passengers and a brother and roommate of one of them. They are suing him for potentially exposing them to the disease. Representing them is Montreal lawyer Anlac Nguyen.

A CTV news report said that the nine people comprise five Montreal residents, two Ottawa residents and two Czech citizens. Between them they are seeking a total of 1.37 million Canadian dollars (1.31 USD).

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Electronic health records have been hailed as a key element in making U.S. medical care more effective and efficient, but a new study led by a researcher at the Stanford University School of Medicine shows that electronic records were not associated with improved quality of outpatient health care in 2003 and 2004.

Of 17 quality indicators assessed by the study, electronic health records made no difference in 14 measures. In two areas, better quality was associated with electronic records, while worse quality was found in one area.

Senior author Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, said that given the overall mediocre performance of physicians in the 17 quality indicator areas, he and his colleagues had expected better quality from doctors using electronic records.

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Since the institution of nationwide folic acid fortification of enriched grains in the mid 1990s, the number of infants born in the United States and Canada with neural tube defects has declined by 20 percent to 50 percent. Concurrent with the institution of fortification, however, the rate at which new cases of colorectal cancer were diagnosed in men and women increased, report researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging (USDA HNRCA) at Tufts University. Joel Mason, MD, director of the USDA HNRCA’s Vitamins and Carcinogenesis Laboratory, and colleagues analyze the temporal association between folic acid fortification and the rise in colorectal cancer rates, and present their resulting hypothesis in an article in the July issue of Cancer Epidemiology Biomarkers & Prevention.

“Nationwide fortification of enriched grains is generally considered one of the greatest advances in public health policy,” says Mason, who is also an associate professor at the Friedman School of Nutrition Science and Policy at Tufts. “But since the time that the food supply in North America was fortified with folic acid, we have been experiencing four to six additional cases of colorectal cancer for every 100,000 individuals each year compared to the trends that existed before fortification.

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In her Brown University laboratory, Edith Mathiowitz makes tiny particles coated in polymers. These microcapsules, some as small as the point of a pin, can carry medicines, genes, paints, pesticides — any molecule that needs protection or controlled release.

Mathiowitz developed her technique as a drug delivery system, but her microcapsules are now being put to a very different use — to make ink for the first permanent removable tattoo. Under a new intellectual property licensing agreement signed by Brown University and Freedom-2 Holdings Inc., the company has the right to make and sell their ink based on research Freedom-2 has funded in the Mathiowitz lab.

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