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Contents
FDA for More
Teeth
Lying to Feds Gets You in Trouble Environmentally Friendly Jobs Alendronate Side Effects Gel to Smuggle Proteins Thalidomide Humira in Japan India's Biologic Company Polyketide Mystery Dr. Reddy's Acquires Genome Sequencing is Faster and Cheaper FDA for More Teeth Rep. John Dingell's House Energy and Commerce Committee released a "discussion draft", planning to convene hearings over the next few weeks and draw up the real bill after that. Some points: Drug and device plants making products for the U.S. market would register annually with the FDA would have to inspect all drug and device facilities every two years; no drug, ingredient, or device could be sold until its plant had been inspected at least once--and FDA approval could be yanked if this rule was violated Importers without documentation that they'd complied with all safety rules could only ship into ports with federal testing labs. Drug and API makers would have to test their products for contaminants. Drug labels would identify the source of active ingredients and specify where a drug was made. The bill would give the FDA stronger enforcement powers, including the ability to recall drugs unilaterally and destroy counterfeit or contaminated imports. The agency would also be able to issue fines for violations. Lying to Feds Gets You in Trouble The Department of Justice announced that the former senior vice president of Bristol-Myers Squibb Company (BMS), Andrew Bodnar, was indicted for his role in lying to the federal government about a patent deal involving the popular blood-thinning drug, Plavix, used by heart attack, stroke and other patients. The Department said that the alleged illegal actions of Bodnar related to the possible introduction of a generic drug that would compete with Plavix. On June 11, 2007, BMS agreed to plead guilty and pay a $1 million criminal fine for misleading the government about the Plavix patent deal. BMS paid the maximum fine permitted by statute for committing two violations under the federal False Statements Act. According to the one-count indictment filed in the U.S. District Court in Washington, D.C., in 2006, BMS and another company, Apotex Inc., were engaged in litigation over the validity of the patent for Plavix and were negotiating a settlement of that litigation. At the time, BMS was subject to a separate consent decree, for unrelated conduct, with the Federal Trade Commission (FTC) that required BMS to submit any proposed patent settlements for review and advisory approval by the FTC. The FTC warned BMS that if BMS agreed with Apotex not to launch BMS's own generic version of Plavix -- meaning that BMS would not compete against Apotex for generic sales -- then the FTC would not approve a settlement of the Plavix litigation. Environmentally Friendly Jobs While many companies are cutting down, Danish drug maker Novo Nordisk and New Jersey Gov. Jon S. Corzine have plans to expand its North American headquarters with an environmentally friendly building that will add hundreds of new jobs. Novo Nordisk, one of the world's largest producers of insulin for diabetes treatment, intends to add 400 workers to its West Windsor facility that now employs 700, said a spokeswoman for Corzine. The building will be environmentally sensitive, with recycled water, long-life light bulbs and other features. The move comes at a key time for New Jersey, which has lost about 10,300 jobs so far this year, according to state labor department figures. Wyeth notified employees that still more jobs are going. This follows an announcement last month that 1,240 sales positions would be eliminated as part of what Wyeth execs are calling ‘Project Impact.’ However, Wyeth announced it will invest $96 million (SGD $134 million) to expand its existing nutritional manufacturing facility in Tuas, Singapore. The expansion was officially announced during a groundbreaking ceremony at the site attended by Company officials and representatives from the Singapore Economic Development Board, which is partnering with Wyeth to support the successful completion of the project. In Michigan, massive expansion of a life sciences research company in the Kalamazoo area, expected to create 3,300 jobs over the next five to seven years. The Michigan Economic Growth Authority (MEGA) board unanimously approved an $86 million high-tech tax credit to MPI Research Inc. over 15 years to expand its campus in Mattawan and employ 400 new workers in downtown Kalamazoo. The downtown move could begin in late summer and the expansion in Mattawan, which is about 10 miles west of Kalamazoo, is ongoing, company officials said. Alendronate Side Effects Alendronate, a medication used to prevent fractures in women with osteoporosis, may be associated with an increased risk of atrial fibrillation, a type of abnormal heart rhythm, according to a report in the April 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Other recent studies have reported atrial fibrillation as an unexpected adverse effect of bisphosphonates, a class of drugs that includes alendronate and other medications that affect the body’s calcium levels, according to background information in the article. Atrial fibrillation occurs when the atria, the smaller upper chambers of the heart, begin to beat irregularly and rapidly. “In conclusion, all drugs have benefits and adverse effects,” the authors continue. “When new information becomes available about a previously unrecognized benefit or adverse effect, physicians and patients must reweigh the current knowledge about benefits and risks in making treatment decisions for each patient. The benefits of fracture prevention in patients at high risk for fracture will generally outweigh the possible risks of atrial fibrillation. However, it is important to carefully weigh the benefits against the possible risk of atrial fibrillation in women who have only modestly increased fracture risk and in women who have risk factors for atrial fibrillation, such as diabetes mellitus, coronary disease or heart failure.” Arch Intern Med. 2008; 168[8]:826-831. Gel to Smuggle Proteins A gel that can smuggle insulin past the stomach and slowly release the drug into the blood could do away with diabetics' daily injections. Pills made from the new material could also deliver other protein-based drugs, such as human growth hormone, that must be protected from being digested in the stomach. The gel is also designed to stick onto the intestine wall, buying time to deliver its insulin payload. An outer coating, composed of a wheat-germ protein called agglutinin, forms structures that grab hold of intestinal cells. Mysteriously, the agglutinin also appears to help the insulin get through the intestinal wall and into the blood stream. Animal trials of the gel are planned to start soon. Biomacromolecules (http://pubs.acs.org/cgi-bin/abstract.cgi/bomaf6/2008/9/i04/abs/bm701274p.html) Thalidomide Celgene International Sàrl announced that Thalidomide Pharmion has been granted full marketing authorization by the European Commission for use in combination with melphalan and prednisone as a treatment for patients with newly diagnosed multiple myeloma. In June 2007, the European Commission granted the Company’s REVLIMID® full marketing authorization as the first oral treatment in more than 40 years for patients with multiple myeloma who have received at least one prior therapy. From 1956 to 1962, approximately 10,000 children were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy. In 1998, the FDA approved the use of thalidomide for the treatment of lesions associated with erythema nodosum leprosum. In 2006, the U.S. Food and Drug Administration granted accelerated approval for thalidomide (Thalomid, Celgene Corporation) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma (MM) patients. Thalidomide was chiefly sold and prescribed during the late 1950s and early 1960s to pregnant women, as an antiemetic to combat morning sickness and as an aid to help them sleep, with catastrophic results for the children of women who had taken thalidomide during their pregnancies. Humira in Japan Abbott announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare for HUMIRA® (adalimumab) for the treatment of rheumatoid arthritis in patients with inadequate response to conventional therapy. This approval is the first for HUMIRA in Japan, where Abbott co-developed and will co-market HUMIRA with Eisai Co., Ltd. HUMIRA is now approved in 75 countries for rheumatoid arthritis and other autoimmune disease indications. Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint inflammation, joint pain and stiffness, which can lead to long-term joint damage. The joints most commonly affected early in the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can also be affected. Although there is no cure for RA, people continue to seek treatments that help alleviate pain and inflammation and slow disease progression. More information on RA and current treatment options can be found at http://www.RA.com. HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn.s disease and plaque psoriasis (Ps) in the United States and Europe. HUMIRA is also approved for the treatment of juvenile idiopathic arthritis (JIA) in the United States, and review for JIA in Europe is ongoing. Clinical trials are underway evaluating the potential of HUMIRA in ulcerative colitis. To date, HUMIRA has been approved in 75 countries and more than 250,000 people worldwide are currently being treated with HUMIRA. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. India's Biologic Company India's top biotechnology firm, Biocon Ltd, is in talks to acquire a U.S. firm in a deal valued at $400 million to boost its overseas pharmaceutical distribution network. Biocon which makes insulin, cholestrol-lowering statins and other branded drugs bought 70 percent of German marketing firm Axicorp GmbH for 30 million euros ($47 million) in February to boost its distribution network in Europe. Polyketide Mystery Many top-selling drugs used to treat cancer and lower cholesterol are made from organic compounds called polyketides, which are found in nature but historically difficult for chemists to alter and reproduce in large quantities. For the first time, scientists at UC Irvine have discovered how polyketides form their ringlike shape, making it easier for chemists to manipulate them into new drugs. The key, they found, is an enzyme called aromatase/cyclase, which forms a C-shape mold in which polyketides can form one molecule at a time. By changing this mold, chemists can control the size and shape of the polyketide, resulting in the formation of new drugs. The research appears online in the Proceedings of the National Academy of Sciences. http://www.sciencedaily.com /releases/2008/04/080401112350.htm Dr. Reddy's Acquires Dr. Reddy’s Laboratories Ltd announced that it has acquired Jet Generici Srl, a company engaged in the sale of generic finished dosages in Italy. The deal has been completed via Dr. Reddy’s Italian subsidiary, Reddy Pharma Italia SpA, which has been engaged in building a pipeline of registrations since its incorporation. The acquisition provides access to an essential product portfolio, a pipeline of registration applications, and a sales and marketing organization. Financial terms and conditions of the transaction are not being disclosed. Dr. Reddy’s Laboratories also announced that it has entered into a definitive agreement with The Dow Chemical Company to acquire a portion of Dowpharma Small Molecules business associated with its United Kingdom sites in Mirfield and Cambridge. The financial terms and conditions of the transaction are not being disclosed at this point in time. The transaction is scheduled to close on April 30, 2008 pending regulatory approval. Dr. Reddy’s Laboratories was established in 1984 in Hyderabad, India, and is a global pharmaceutical company with proven research capabilities. Dr. Reddy’s conducts research in the areas of diabetes, obesity, cardiovascular diseases, anti-infectives and inflammation. Genome Sequencing is Faster and Cheaper The first full genome to be sequenced using next-generation rapid-sequencing technology is published in Nature, marking another milestone in the field of human genome sequencing. It took just four months, a handful of scientists and less than US$1.5 million to sequence the 6 billion base pairs of DNA pioneer James Watson. The achievement is first proof of principle that these rapid-sequencing machines can decipher large, complex genomes (see Nature, page 819). Made in this case by Connecticut-based 454 Life Sciences, a division of Roche Diagnostics, they allow many more sequencing reactions to proceed at the same time, on the same surface, than the previous generation of machines that produced the inaugural human genomes. That change has had big pay-offs in speed, efficiency and, ultimately, cost (see Table 1). James Watson's is not the first full genome to be published; that distinction goes to genomics entrepreneur J. Craig Venter, whose genome was sequenced using previous-generation machines at a cost of $100 million. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, 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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