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Over three years, the SANDS trial (Stop Atherosclerosis in Native Diabetics Study), published online by the Journal of the American College of Cardiology, compared two treatment targets in 427 American Indian patients with type 2 diabetes. In the group that reached aggressive lipid-lowering targets (LDL 70 mg/dl or less), reductions were found in the carotid artery intima-media thickness. Caroti
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2008.12.07 00:00
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A study published in the journal Neurology of Dec. 2 researched a total of 632 children of 620 mothers, of who 296 women with epilepsy, who used various anti-epilepsy drugs at the beginning of pregnancy and 336 women without epilepsy and therefore not taking these medications. Children whose mothers were taking valproate alone for epilepsy (64 women) were 7 times more likely to develop autism, tha
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2008.12.07 00:00
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In the ACCOMPLISH study (Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension) published in the New England Journal of Medicin of Dec 4, more than 11 thousand high risk cardiovascular patients with hypertension were assigned to an ACE inhibitor (benazepril) combined with either a calcium channel blocker (amlodipine) or hydrochlorothiazide. After
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2008.12.07 00:00
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Manufacturer Allergan applied for FDA approval of Lumigan (bimatoprost) under brand name Latisse as a cosmetic article for the enhancement of eyelashes. At the moment bimatoprost is sold for the treatment of glaucoma related problems. The FDA will decide shortly on the application.
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2008.12.05 00:00
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A study that will be published in the Canadian Medical Association Journal next month, evaluates the results from forty nine clinical trials of anti-bleeding drugs, used during surgery. Trasylol (aprotinin) seems to have an advantage in containing blood loss, but its drawbacks are a higher death risk and a higher price. Tranexamic acid or aminocaproic acid are recommended as alternatives to preven
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2008.12.04 00:00
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Novartis applied for FDA approval of Coartem, a malaria drug based on the compound artemisinin, which in trials had a success rate of ninety percent after twenty eight days of treatment. The medication has been tried in eighty three countries around the globe, during which side effects like vertigo and migraines have been noted. The FDA is expected to decide by the end of December, after a fast-tr
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2008.12.04 00:00
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Creon (pancrelipase), produced by drug maker Solvay, obtained from pig pancreas glands, can replace pancreatic enzymes normally excreted by the pancreas. Study results indicate the treatment’s effectiveness in relieving gastrointestinal effects of a lack of such enzymes caused by certain disorders, like cystic fibrosis. The possibility of viral contamination remains a concern and needs to be addre
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2008.12.04 00:00
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Dates: Mar 1-4, 2009Location: Hilton Head Marriott Resort and Spa, Hilton Head Island, SC 29928, USA9 exciting, interactive breakout sessions – on topics essential to medical information and liaisonsTarget audiences: Medical Communications, Medical/Scientific Writing, Marketing/Advertising, RA/Policy/Drug or Device Approval/GRP, Over-the-Counter, Information Management, Document Management
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2008.12.04 00:00
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Teva Pharmaceutical Industries, Ltd. became the world"s biggest maker of generic medicines through a high-risk strategy of defying drug patents. Teva starts selling generics while patents on a drug are still valid and thus risks paying legal damages. The company simply bets it will win in court, which has succeeded so far in thirteen cases.
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2008.12.03 00:00
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The two drugmakers Cephalon, Inc. and Alkermes, Inc. ended their partnership in the development of Vivitrol (naltrexone), an injected drug to treat alcoholism. The companies announced that Alkermes will have full commercialization rights from now on. Cephalon will pay Alkermes to cover expected losses on Vivitrol for the next year and Alkermes will reimburse Cephalon for the equipment to manufactu
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2008.12.03 00:00
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A study, published online in The Lancet, in which 450 people underwent simulated jet lag in a sleep laboratory, found that the tasimelteon (Vanda Pharmaceuticals) group slept thirty minutes longer than the placebo group. Tasimelteon activates the receptors, which process a hormone produced at night that regulates the sleep cycle, like melatonin. Unclear is if the new drug is more effective than me
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2008.12.03 00:00
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Join Regulatory Affairs CMC (Chemistry, Manufacturing & Controls) professionals to build a solid foundation in basic scientific disciplines & principles applied in CMC drug development. The program developed by the CMC Working Group of the DIA Regulatory Affairs Special Interest Community (SIAC) and presented in collaboration with the American Association of Pharmaceutical Scientists (AAPS).Februa
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2008.12.03 00:00
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The use of technology to create, manage, and submit vital information to regulatory authorities is critical to the success of pharmaceutical and biotechnology companies in the drug development process. Keeping up to date in this field is challenging due to constant changes in technical standards, technical developments and global regulatory requirements. The DIA Conference provides a platform for
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2008.12.03 00:00
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This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail.January 26-27, Grand Hyatt, San Francisco, CA
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2008.12.02 00:00
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This comprehensive four-day program will address the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use of medical products. Jan 11-15, 2009, The Renaissance Washington, DC Hotel, USA
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2008.12.02 00:00
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Indonesia recently ruled that foreign drug manufacturers will only be allowed to sell their products if they are produced within the country borders. At the moment 13 companies, including giants such as Eli Lilly, Merck, Sanofi-Aventis, and AstraZeneca, sell their drugs in Indonesia, but don"t have production facilities there.
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2008.12.02 00:00
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Researchers from the University of Illinois, Stanford University and others will discuss in the journal of Pharmacotherapy next month the practice of prescribing medications for other purposes than those approved for by the FDA, the so called “off-label use”, which is sometimes encouraged by manufacturers. The researchers have identified 14 such medications, most of them psychiatric drugs, and cal
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2008.12.02 00:00
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Shares of drug company Basilea fell dramatically after the FDA refused to approve ceftobiprole, a treatment for MRSA (Methicillin Resistant Staphyloccus Aureus) and other serious infections. Reviewers were concerned about the credibility of three sites involved in the study, which could delay US authorization up to eighteen months.
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2008.12.02 00:00
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FDA reviewers demanded more data on Motavizumab, used to prevent respiratory syncytial virus (RSV) infections, before allowing it on the market. RSV is the major cause of lower respiratory tract infection during infancy and childhood. AstraZeneca PLC intended to launch Motavizumab in the second half of next year.
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2008.12.02 00:00
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Eli Lilly & Co. has withdrawn its application for FDA approval of Cymbalta (duloxetine) for use as chronic-pain medicine, after FDA reviewers questioned the effectiveness of the drug as a painkiller because of a lack of statistical methodology. The drug company intends to reapply in six months.
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2008.12.02 00:00