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FDA in recent months has rejected a “slew” of new drug applications or delayed approval of experimental medications and required more data, as the agency faces increasing concern over drug safety since the painkiller Vioxx was pulled from the market in 2004, the AP/Baltimore Sun reports. FDA this year has approved 61% of new drug applications through mid-August, compared with 73% during the same period last year.

The AP/Sun reports that the increased rejections have affected patients’ access to new medications, hurt drug manufacturers stock prices and are expected to increase the time and cost of developing new and future medications. Steve Brozak, an analyst with WBB Securities, said, “The FDA is being more cautious” because it realizes that new medications will be used off-label, which can increase the risk of serious side effects. Brozak said the agency’s mentality now is that it has “got to be so safe that we’re not going to be criticized ever” for approving the drug.

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Computer analysis of existing drugs may be key to fighting new infectious agents and antibiotic-resistant pathogens like deadly tuberculosis strains and staph ’superbugs.’ Researchers in Canada say the use of such “emergency discovery” technology could save time, money and lives during a sudden outbreak or a bioterrorism attack. They reported at the 234th national meeting of the American Chemical Society.

Drug ‘repurposing’ or ‘reprofiling’ is not new: Pharmaceutical companies have been seeking new uses of old drugs to extend patent protections and whenever new, off-label uses of the drugs are found. But reprofiling to deliberately develop emergency drugs is a new concept, made possible by advances in chemoinformatics, a new field that merges chemistry with computer science, according to study presenter Artem Cherkasov, Ph.D., of the University of British Columbia in Vancouver, Canada.

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Older patients and people taking multiple medications are set to benefit from better packaging of their medicines by pharmacists.

The Commonwealth Government has provided up to $72.9 million to the Pharmacy Guild of Australia through the Fourth Pharmacy Agreement for the Dose Administration Aids program.

The program provides support to community pharmacists to help patients manage their medication by packaging it into individual doses that are arranged according to the dose schedule throughout the day. The packaging can be either a unit-dose pack (one single type of medication per compartment) or a multi-dose pack (different types of medication per compartment).

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Swiss drug maker Novartis announced that Reclast (zoledronic acid) has received approval from the US Food and Drug Administration (FDA) as a once a year treatment for women with osteoporosis.

Osteoporosis (literally means “porous bones”) occurs when bone mineral density (BMD) falls and the physical and chemical structure inside bones is disrupted leading to skeletal fragility and bones that fracture easily (it is sometimes called brittle bone disease).

Osteoporosis is caused by a combination of genetic, dietary, lifestyle, hormonal, and age-related factors. It occurs most commonly in postmenopausal women and most treatments are aimed at this group.

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Total spending on advertising by the pharmaceutical industry has increased by an average of 10.6% annually since 1996, when a rule change allowed drug companies to advertise directly to consumers, according to a study published on Wednesday in the New England Journal of Medicine, Reuters/Newark Star-Ledger reports.

For the study, Julie Donohue of the University of Pittsburgh Graduate School of Public Health and colleagues analyzed industry data from three market-research firms that track drug industry advertising spending. According to the study, researchers “also obtained information from researchers and staff members at the FDA and other government agencies.”

The study found that overall spending on drug advertising increased from $11.4 billion in 1996 to $29.9 billion in 2005. Direct-to-consumer advertisements, which account for 14% of total advertising spending by the industry, increased by 330% from 1996 to 2005, the study found.

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Research from The University of Nottingham sheds new light on a fascinating phenomenon of the natural world — the ability of some species to reproduce sexually without a partner.

Scientists have been trying to determine how individuals of a key fungus, Aspergillus nidulans, are able to have sex without the need for a partner.

In new findings published in the journal Current Biology, they reveal that the fungus has evolved to incorporate the two different sexes into the same individual.

This means that when sex occurs the fungus activates its internal sexual machinery and in essence ‘mates with itself’ to produce new offspring, rather than bypassing the sexual act.

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The U.S. Pharmacopeia’s (USP) Annual Scientific Meeting will feature important information on USP’s approach to quality of manufactured medicines, quality of care and international health — and the standards USP is implementing. The meeting will be held September 25-27, 2007, at the Hyatt Regency Tampa, in Tampa, Fla.

The meeting is a must-attend for USP-NF and USP Reference Standards users, academia and association representatives, compendial affairs personnel, government representatives, healthcare practitioners, lab supervisors, research and development personnel, statisticians, technical consultants, quality control personnel, and scientists focusing on analytical validation and excipients, biologics and biotechnology, chemistry, impurities and medication/patient safety.

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Gilead Sciences, Inc., one of the world’s largest biopharmaceutical companies, and Parion Sciences, Inc., a development-stage pharmaceutical company, announced they will co-develop Parion 680, a compound that could become an important new drug in treating the basic defect in cystic fibrosis. This product was identified as part of a $1.7 million award to Parion from Cystic Fibrosis Foundation Therapeutics, Inc.-the CF Foundation’s nonprofit drug discovery and development affiliate.

“This news validates our ‘venture philanthropy’ approach to drug development,” said Robert J. Beall, Ph.D, President and CEO of the Cystic Fibrosis Foundation. “We are a small disease, but as we have proven again and again, making the right investment in the early stages has an impact on how drugs are developed for cystic fibrosis. That is why the Foundation has been able to build a robust drug development pipeline that has nearly 30 promising therapies.”

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The National Community Pharmacists Association (NCPA), the American Pharmacists Association (APhA), the National Alliance of State Pharmacy Associations (NASPA) and Mirixa Corporation announced the beta launch of http://www.RxWiki.com, the first Web 2.0 medication therapy management encyclopedia for consumers, written and edited by pharmacists. RxWiki is a free website publishing pharmaceutical, over-the-counter, and nutraceutical medication information. RxWiki also serves as a community network for pharmacists to create and share information for their patients and consumers at large, and to collaborate in the advancement of Medication Therapy Management (MTM).

“Today, 34% of all US online consumers use Wikipedia, and 7% of US online consumers with medical conditions used peer-edited health information in the past 12 months. The mission of RxWiki is to become the Web’s most trusted source of medication information,” said NCPA Executive Vice President and CEO Bruce Roberts. “NCPA, APhA and NASPA all believe our member pharmacists will gain tremendous professional satisfaction from contributing to this new medium knowing it will be one more way they improve consumers’ use of medications.”

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Healthcare organizations involved in the manufacturing, distribution and dispensing of pharmaceutical products came together to announce the creation of RxResponse, - a program designed to help support the continued delivery of medicines during a severe public health emergency. The partnership includes the American Hospital Association, American Red Cross, Biotechnology Industry Organization, Healthcare Distribution Management Association, National Association of Chain Drug Stores, National Community Pharmacists Association and the Pharmaceutical Research and Manufacturers of America.

“During a disaster, it is vital that systems are in place to assist with the continued delivery of medicines to hospitals, healthcare providers and patients in need,” said Billy Tauzin, president and CEO, Pharmaceutical Research and Manufacturers of America (PhRMA). “Rx Response is a partnership dedicated to assist with the delivery of critical medicines to patients whose health is threatened during a crisis.”

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GlaxoSmithKline on Wednesday announced that it has given consent to Toronto-based drug company Apotex to use two of its patented antiretroviral drugs, lamivudine and zidovudine, to manufacture Apo-triAvir — a fixed-dose combination of the two drugs and the antiretroviral nevirapine — for Rwanda, the Toronto Star reports. According to the Star, consent was given through Canada’s Access to Medicines Regime (Talaga, Toronto Star, 8/9).

The World Trade Organization last month in a statement announced that Rwanda plans to override the pharmaceutical patents and import 260,000 packs of Apo-triAvir. Under an August 2003 waiver to WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the “paragraph 6 system,” developing countries with a public health crisis are allowed to import generic drugs when they cannot manufacture the drugs themselves. According to WTO, Rwanda is the first country to use the waiver, which would allow it to import generic drugs that are manufactured under compulsory licenses in other countries. The TRIPS waiver submission was made last month by the Treatment and Research AIDS Centre. Rwanda plans to import the 260,000 packets during the next two years (Kaiser Daily HIV/AIDS Report, 7/25).

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The U.S. Court of Appeals for the District of Columbia issued a decision of “poor quality” on Tuesday when it ruled that terminally ill patients do not have the right to obtain access to unapproved prescription drugs that potentially are lifesaving, Roger Pilon, vice president for legal affairs at the Cato Institute and director of Cato’s Center for Constitutional Studies, writes in a Wall Street Journal opinion piece (Pilon, Wall Street Journal, 8/10).

In 2003, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation filed a lawsuit against FDA to obtain access to experimental medications for terminally ill cancer patients. The lawsuit asked FDA to provide a special initial approval of experimental medications that appear effective and allow their sale and distribution to terminally ill patients who have no other approved treatment options.

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FDA on Thursday announced (PDF) that it is reviewing all available safety data on omeprazole and esomeprazole after information emerging in clinical trials of the drugs hinted that they might put patients at risk for cardiovascular events.

But the review, which began in May, has not failed to confirm the problem, which was brought to the agency’s notice by the products’ manufacturer, AstraZeneca.

“Upon initial examination and review of all the available data that we have to date, FDA has concluded preliminarily that these data do not suggest an increased risk of heart problems in patients treated with either of these products,” said Paul Seligman, associate director of FDA’s Office of Safety Policy and Communication, during a media briefing Thursday.

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FDA this week warned two companies to immediately stop promoting and selling red yeast products that contain the cholesterol-lowering drug lovastatin.

A warning letter was issued Tuesday to Sunburst Biorganics of Baldwin, New York, for the company’s Cholestrix red rice and yeast extract product. FDA issued a letter the next day to Swanson Health Products of Fargo, North Dakota, for the company’s Red Yeast Rice and Read Yeast Rice/Policosanol dietary supplements.

According to FDA, Swanson’s products, if taken as advertised on the company’s website, provide more than 5 mg of lovastatin daily, or half the lowest-recommended daily dose of FDA-approved formulations of the drug.

FDA stated that Sunburst’s product, Cholestrix, is advertised as containing “1.35% of naturally occurring lovastatin,” with two tablets daily providing 10 mg of the drug.

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FDA and Pfizer Inc. announced the approval of Selzentry, or maraviroc, the first agent in a new class of oral HIV medications: chemokine receptor 5 (CCR5) coreceptor antagonists.

By selectively blocking the CCR5 coreceptor, which is HIV’s predominant route of entry into T cells, maraviroc prevents CCR5-tropic HIV-1 from entering the cells. All other oral HIV treatments on the market combat the virus once it has already entered T cells, according to Pfizer.

According to the product’s FDA-approved labeling (PDF), Selzentry is indicated in combination with other antiretroviral medications for the treatment of adult patients with only CCR5-tropic HIV-1 detectable disease and evidence of viral replication despite treatment with other antiretroviral agents.

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IBM on Thursday launched an electronic “pedigree” system that will help fight prescription drug counterfeiting using radio-frequency identification tags, the AP/Houston Chronicle reports. The ePedigree system allows drug companies to create electronic certificates of authenticity for drugs and track them through the supply chain and into the hands of consumers. The tags also will keep track of expiration dates, batch numbers to be used in case of a recall and other information.

Chris Clauss, IBM Software’s director of sensor information management, said the RFID tags are not a guarantee against counterfeiting, but they will “raise the bar” and make such activity more difficult. A California law scheduled to take effect in 2009 will mandate that any drug distributed in the state has its pedigree attached, according to the AP/Chronicle. Past attempts to combat fake drugs — including holograms and watermarks — often were illegally “reproduced within months, to the point where brand managers could not tell the difference between the counterfeit and the real thing,” the AP/Chronicle reports (Ortutay, AP/Houston Chronicle, 8/9).

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The European Commission on Tuesday suspended Swiss pharmaceutical company Roche’s license to market its antiretroviral drug Viracept because of contamination with the substance ethyl mesilate in certain lots of the drug, Reuters reports (Reuters, 8/7). According to the AP/International Herald Tribune, ethyl mesilate can damage DNA and lead to cancer (AP/International Herald Tribune, 8/7).

The European Medicines Agency in June recalled Viracept because of contamination. Roche in a statement said that it recalled all batches of the drug in Europe and other undisclosed countries in cooperation with EMA and Swissmedic, Switzerland’s drug regulator. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester — a chemical normally used in the drug in small quantities.

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The US Food and Drug Administration (FDA) said yesterday that a preliminary review of new data on the safety of two stomach drugs made by AstraZeneca, Prilosec (generic name omeprazole) and Nexium (generic name esomeprazole) suggests that long term use of these medications does not lead to heart attacks and other heart related events. The agency said for the time being, until a final decision and recommendation is made in three months’s time, health professionals and patients should not change their current practice in the use of these drugs.

Prilosec and Nexium are proton pump inhibitors (PPIs) used to control stomach acid. They are taken by patients with a range of gastrointestinal conditions such as ulcers and gastroesophageal reflux disease (GERD). Some GERD conditions erode the lining of the food pipe (esophagus) and PPIs help to heal the erosions or stop them getting worse. Prilosec and Nexium are available in the US by prescription, although Prilosec is also dispensed over the counter for heartburn.

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As patents expire over the next five years for brand-name prescription drugs with more than $60 billion in combined annual sales, some health care experts predict that new generic equivalents will maintain single-digit drug price inflation for U.S. consumers, the New York Times reports. Generic drugs typically are 30% to 80% less expensive than brand-name versions, contain the same active ingredients and are approved by FDA under the same standards as brand-name drugs.

Expiring patent protection for some drugs, such as Sanofi-Aventis‘ sleeping pill Ambien, has been cutting into brand-name manufacturers’ revenue, and several blockbuster drugs are set to face generic competition over the next five years, including Fosamax, a drug that slows bone loss, and the cholesterol-lowering drug Lipitor, the Times reports. Some companies, such as pharmacy benefit manager Express Scripts, and Medicare prescription drug plans are encouraging use of generics by lowering copayments for the drugs versus their brand-name equivalent.

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The University of Illinois at Chicago College of Pharmacy has received a grant from the U.S. Department of Defense to develop new drugs to combat agents of bioterrorism.

The one-year, $880,000 grant will fund the college’s new Institute for Advanced Pharmaceutical Sciences. The center will discover new and effective medicines to fight bioterrorism and assist the college in obtaining additional funding sources to develop medicines to fight other infectious and chronic diseases such as tuberculosis, cancer, neurodegenerative diseases and bipolar disorder.

“Anthrax has been identified by the Centers for Disease Control and Prevention as one of the most serious threats of bioterrorism, and UIC’s College of Pharmacy has an extensive research program devoted to the discovery and development of antibiotics for the treatment of this and other infectious diseases,” said Jerry Bauman, dean of the College of Pharmacy. “This grant will allow us to expand on our current studies.”

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