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Contents
Drugs from Genetically Altered Animals Weight-loss Pills Laced with Drugs Email Etiquette FDA halts review of drugs from Ranbaxy plant Neurons from Stem Cells Good Bacteria to Deliver Vaccines Constipation in Japan Nanobodies Generic Migraine Drug Over the Counter Cold Medicines Under Scrutiny Drugs from Genetically Altered Animals The drug, GTC Biotherapeutics Inc's anti-clotting therapy Atryn, is an intravenous therapy made using a human protein gathered from female goats that have been genetically altered to produce extra antithrombin, a protein that acts as a natural blood thinner. The U.S. Food and Drug Administration (FDA) approved the first drug made using genetically engineered animals, clearing the way for a new class of medical therapies. Vaccines Do Not Cause Autism Vaccines did not cause autism in three children whose families filed claims with the U.S. government, a special court ruled this week. The U.S. Court of Claims ruled that the scientific evidence does not support the idea that vaccines can cause autism. The parents' case was "speculative and unpersuasive," the court said in one case. More than 5,500 claims related to autism have been filed through the government's Vaccine Injury Compensation Program. This program makes payments to families who can show that a child was killed or injured by a vaccine. Suits against the vaccine makers are not allowed. Weight-loss Pills Laced with Drugs The Food and Drug Administration says the weight-loss capsules, such as StarCaps, promoted as natural dietary supplements using papaya, could be hazardous to your health. In violation of the law, the agency has found, the capsules also contained a potent pharmaceutical drug called bumetanide, which can have serious side effects. In a continuing investigation that has prompted consumer warnings and recalls by some distributors, the F.D.A. has determined that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs. Besides StarCaps, which were made in Peru and which Balanced Health Products, the American distributor, has voluntarily withdrawn, the agency’s warning list includes more obscure pills sold under the names Sliminate, Superslim and Slim Up, among many others. So far, the F.D.A. has cited 69 tainted weight-loss supplements. If a weight-loss supplement does contain an undeclared active pharmaceutical, the F.D.A. considers the product to be an illegal, unapproved drug. Doctors said undeclared drugs could cause problems on their own, like elevated blood pressure or seizures, could have toxic interactions with other medications and could make it difficult for physicians to diagnose patients. The main law on dietary supplements of 1994 gives the F.D.A. jurisdiction only after the products go on the market. Rather than reviewing the supplements and approving them for sale, as the agency does with drugs, the F.D.A. is limited to spot-checking manufacturers and distributors, and testing products already on store shelves. Even the F.D.A. acknowledges there may be hundreds of other drug-contaminated weight-loss supplements for sale that the agency does not have the resources to identify. But even when the agency identifies contaminated products, it does not have the ability to remove the pills from stores, because it is initially up to companies to issue a recall. Eventually, though, if contaminated products stay on the market, the F.D.A. can seek injunctions, seize products or file criminal charges. Of the nearly $24 billion spent on dietary supplements in this country in 2007, about $1.7 billion went for weight-loss pills, according to Nutrition Business Journal, a market research firm. About 15 percent of American adults said they had used weight-loss supplements and the majority failed to inform their doctors about it, according to a phone questionnaire of 9,500 adults conducted by the Centers for Disease Control and Prevention. http://www.nytimes.com/2009/02/10/business/10pills.html?_r=3&partner=rss&emc=rss Email Etiquette 1. Follow The Golden Rule Assume that your e-mail will be printed on the front page of the New York Times. If you would be embarrassed or concerned, don't send it. 2. Don't E-Mail If You Can Telephone Or Meet In Person E-mail is not a replacement for personal conversation. Comments and suggestions can be said in a conversation that suddenly and surprisingly become misinterpreted, embarrassing or harmful in an e-mail. 3. Never Ever Send E-Mail When You Are Angry Or Tired Fatigue will cause you to lose patience and send something you will later regret. Never send an e-mail when tired or angry. 4. Never Joke In E-Mails What you are sending may seem hysterical to you, but don't do it. You never really know the mood of the person receiving the e-mail. 5. Take Your Time In Writing E-Mails The more quickly you send out an e-mail, the more likely it will miss the mark. Communication is an art. 6. Don't Gossip In E-Mail Don't use e-mail to gossip about friends or colleagues. More often than not, some "well-meaning friend" will thoughtlessly forward it to someone you would not have wanted to see it, or worse, to the person you are gossiping about. 7. Be Gentle The old adage "sticks and stones may break my bones, but names will never hurt me" does not apply to e-mail. Keep a business tone in your e-mails. Praise others publicly, but criticize privately and in-person. 8. Don't Copy Everyone Keep your distribution groups small. Send e-mails on a need-to- know basis. Don't hit "reply to all" without thinking. 9. Edit E-Mails Yourself Or Ask A Colleague To Look Over Important E-Mails E-mail is a form of written communication. Writing has rules, they work, use them. Stick with proper grammar. 10. Don't Assume That Spell Check Will Catch Every Error Use Spell Check, but don't rely on it. Carefully read all emails before hitting the Send button. 11. Don’t Use abbreviations You may know the abbreviation, but recipient may not. http://www.mondaq.com/article.asp?articleid=74900&email_access=on FDA halts review of drugs from Ranbaxy plant Associated Press, 02.25.09, 11:24 AM EST U.S. regulators say India's largest drugmaker has falsified test results for some of its generic drugs. The Food and Drug Administration says it is halting any consideration of new drugs from a plant owned by Ranbaxy Laboratories, saying officials there falsified data on drugs submitted to the agency. Yahoo! BuzzRegulators say some of the drugs are already on the market. Despite the fraudulent data, regulators say they have no evidence the drugs are dangerous and recommend patients continue taking their prescriptions. The action comes six months after the FDA closed U.S. borders to more than 30 generic drugs made by Ranbaxy after uncovering quality problems at two factories. Neurons from Stem Cells The formula scientists concocted to make adult stem cells work like embryonic-like stem cells is now much more simple to perform. For the first time, a new report in the journal Cell, shows how neural stem cells taken from adult mice can take on characteristics of embryonic stem cells. In another report, researchers said they had made a type of nerve cell out of ordinary skin cells in a new approach to stem cell research. They made motor neurons out of induced pluripotent stem cells, or iPS cells. Scientists hope that iPS cells might offer a substitute for embryonic stem cells and a short-cut to tailored medical therapy for a range of diseases. Motor neurons make muscles contract, and being able to make new motor neurons might help treat diseases such as amyotrophic lateral sclerosis, or ALS. "IPS-derived cells appeared to follow a normal developmental progression associated with motor neuron formation," they wrote in the journal Stem Cells. They looked like neurons taken from human embryonic stem cells, the researchers added. Stem cells are the body's master cells, and a type taken from days-old embryos, called embryonic stem cells, have the ability to morph into any cell or tissue type in the body. Good Bacteria to Deliver Vaccines Lactobacillus acidophilus, the good bacteria, are naturally found in dairy products like yoghurt and cheese. They are used in food fermentation and are safe for consumption. Some are considered as probiotics that contribute to our general health and well-being. Researchers at North Carolina State University have discovered that the good bacteria found in dairy products and linked to positive health benefits in the human body might also be an effective vehicle for an oral vaccine that can provide immunity to anthrax exposure. The approach could possibly be used to deliver any number of specific vaccines that could block other types of viruses and pathogens. The oral vaccine riding inside the good bacteria makes it way through the stomach and into the small intestine, an important immunological organ, where it easily and efficiently binds to cells that trigger an immune response – in this case, protection against anthrax in mice. The finding, published in the Proceedings of the National Academy of Sciences, shows that an oral vaccine can be as effective as one given by needle, a potentially huge advance in drug delivery. Most vaccines are proteins, and as such normally won't maintain their effectiveness after being digested in the stomach. The study was funded by a grant from the National Institutes of Health and the North Carolina Dairy Foundation. Constipation in Japan Sucampo Pharmaceuticals, Inc. announced that its subsidiary, Sucampo Pharma, Ltd., has entered into a license and commercialization agreement with Abbott Japan Co. Ltd. for Sucampo’s lubiprostone (trade name Amitiza®) in Japan. Lubiprostone is the only FDA-approved treatment for chronic idiopathic constipation (CIC) in adults and for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women. In September 2008, Sucampo reported results from a phase 2b dose-ranging study of lubiprostone for CIC in Japanese patients. Based on these results, Sucampo plans to initiate phase 3 clinical testing of lubiprostone for CIC in Japan in the second quarter of 2009. Lubiprostone is a selective activator of type-2 chloride channels through which negatively charged chloride ions flow out of the cells lining the small intestine and into the intestinal cavity. As these negatively charged chloride ions enter the intestine, positively charged sodium ions move through spaces between the cells into the intestine to balance the negative charge of the chloride ions. As these sodium ions move into the intestine, water is also allowed to pass into the intestine through these spaces between the cells. This movement of water into the small intestine promotes fluid content, which in turn softens the stool and facilitates its movement, or motility, through the intestine. Nanobodies Antibodies have provided some of biotech's biggest blockbusters. But they have a distinct limitation. They are big, complex and rather fragile. Scientists, though, are now studying the small antibodies found in llamas and camels that promise to be able to offer better therapies for some of the world's biggest diseases, including cancer, Alzheimer's, arthritis and more. Belgium's Ablynx is collaborating with Novartis exploring nanobodies, which are smaller than antibodies but easier to use. Novartis has the commercial rights to nanobody products developed in the partnership. Ablynx has struck deals with Wyeth, Boehringer Ingelheim and Novartis. Ablynx is developing a new approach to deliver antibodies that can be delivered orally instead of injected. If it works, production costs will drop. And researchers have the potential to assemble antibodies into a molecule that can target a variety of proteins--potentially offering a new approach to fighting cancer. Haptogen is researching shark antibodies and Domantis is re-engineering larger antibodies into smaller packages. To the winner of this race goes a very big market. Generic Migraine Drug Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline’s Imitrex® Tablets, 25 mg, 50 mg and 100 mg for treatment of acute migraine attacks. Shipment of this product has commenced. As one of the first companies to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity. Annual sales of this product were approximately $1 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data. Over the Counter Cold Medicines Under Scrutiny in Britain The effectiveness of some over-the-counter cough and cold medicines for children under 12 has been placed in doubt by a British government watchdog. A review by the Medicines and Healthcare products Regulatory Agency (MHRA) found "no robust evidence" that many popular remedies work in children. The MHRA has said 36 medicines should no longer be sold for children aged under six. It has named eight cough mixtures that can be used for this age group. In very rare cases some of the medicines can cause allergic reactions and hallucinations, RECOMMENDED FOR UNDER 6s Baby Meltus Cough Linctus Beechams Veno's Honey and Lemon (not to be given under one year) Benylin Children's Tickly Coughs (not to be given under three months) Benylin Tickly Coughs (non-drowsy) (not to be given under one year) CalCough Tickly Care Glycerin Lemon & Honey with Glucose (not to be given under one year) Lemsip Cough Dry Tixylix Baby Syrup (not to be given under three months) Pain relief products such as Calpol are not affected by the new advice. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, CNN, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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