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Fitch Ratings, an international ratings agency, reported on Dec. 10 that new drug applications face longer review periods at both US and EU regulatory agencies during the third quarter, creating a massive accumulation of potential approvals. This results from a more cautious approach in reviewing new drug applications, especially in the US, where the FDA has suffered recently a flood of safety is
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2008.12.12 00:00
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Pfizer Inc. and Sigma-Tau Industrie, an Italian drug company, announced Dec. 9 they will jointly market Eurartesim, a potential malaria treatment in Africa after the drug passes regulatory approval. Eurartesim (dihydroartemisinin-piperaquine) is a treatment for uncomplicated malaria in adults and children that reduces the potential for re-infection. The partners expect to file for EMA and FDA regi
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2008.12.12 00:00
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A study involving more than three thousand patients, presented at the annual meeting of the American Society of Hematology, found that J&J and Bayer"s rivaroxaban (Xarelto) was more effective than warfarin, in preventing deep vein thrombosis, in patients after knee-replacement surgery. Rivaroxaban, works by blocking the enzyme factor Xa, which the body uses to stop bleeding. An blood-thinning pro
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2008.12.12 00:00
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FDA advisers said Dec.10 that the side-effects of a new imaging drug, Imagify, made by Acusphere, outweigh any advantages it has over older products. Imagify (perflubutane polymer microspheres) can help identify blood-flow problems in patients with stable chest pain. The side effects reported were acute inflammation, abnormally low blood pressure and fainting spells.
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2008.12.12 00:00
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An FDA panel of medical experts is weighing if the currently approved asthma drugs Advair (fluticasone and salmeterol), Symbicort (budesonide and formoterol), Serevent (salmeterol), and Foradil (formoterol), which contain a kind of long-acting medication known as a LABA (long-acting beta agonists), should be abandoned for the treatment of asthma in children and adults. LABA relaxes tight muscles a
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2008.12.12 00:00
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Research by the Massachusetts General Hospital presented at the annual meeting of the American Society of Hematology provides evidence that the recently FDA approved drug romiplostim (Nplate) for idiopathic thrombocytopenic purpura (ITP) continues to be beneficial up to four years of treatment. Platelet counts were maintained at levels seen early in treatment among 215 ITP patients who continued i
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2008.12.11 00:00
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The application of Targanta Therapeutics Corp. for oritavancin, a treatment against antibiotic-resistant staphylococcal infections, has been rejected by the FDA because of safety concerns. The agency is also worried that the drug doesn"t work against the most dangerous germs and called for an additional study.
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2008.12.11 00:00
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Merck & Co. has announced that it will create a unit to make copies of lucrative biotech drugs, a potentially profitable market. Merck will invest $1.5 billion in its new BioVentures division that will make both new and generic, biotech drugs. Generic biologic drugs are attractive because they will be far more expensive than traditional generic drugs but will still be cheaper to develop than bra
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2008.12.11 00:00
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Findings presented at the annual meeting of the American Society of Hematology, by the Oregon Health & Science University"s Knight Cancer Institute, report of an experimental drug called CYT387 that is able to block an enzyme that causes myeloproliferative disorders (MPDs), or bone marrow cancers. In animal tests CYT387 could inhibit an enzyme mutation called JAK2-V617F, which causes the developm
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2008.12.11 00:00
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According to a study published online in the Canadian Medical Association Journal long-term use of Avandia (rosiglitgizone, GlaxoSmithKline) and Actos (pioglitazone, Eli Lilly), type 2 diabetes drugs of the thiazolidinediones group, may double the risk of bone fractures in women. Researchers analyzed the results of ten previous trials, and discovered that for every twenty women in their 70s with t
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2008.12.11 00:00
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According to the results of two clinical trials reported at the annual meeting of the American Society of Hematology Dec. 7, Genentech Inc. and Roche Holding AG"s drug Rituxan (rituximab) helped patients with chronic lymphocytic leukemia (CLL), keeping the blood cancer from progressing. Of the1369 patients, who participated in the 2 studies together, those given Rituxan combined with chemotherapy
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2008.12.10 00:00
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AstraZeneca PLC and Targacept Inc.said their experimental schizophrenia drug, AZD3480, failed to meet the goals of a clinical study and the companies won"t pursue further development for schizophrenia. In September, the companies announced that the drug proved ineffective for Alzheimer’s patients as well.
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2008.12.10 00:00
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According to research presented at the annual meeting of the American Society of Hematology Dec. 8, is the addition of rituximab (Rituxan) to standard therapy for idiopathic thrombocytopenic purpura (ITP) safe and effective. The sustained response rate, defined as a platelet count of at least 50x109 per liter, among patients that were assigned to dexamethasone with rituximab, was 63%, compared w
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2008.12.10 00:00
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AstraZeneca PLC and Bristol-Myers Squibb Co. plan to extend their international deal to co-develop dapagliflozin, a new diabetes drug, to include Japan. The medication is a SGLT-2 inhibitor, which may regulate the reabsorption of glucose in the kidney, and is in phase III clinical trials in several countries, as a once-daily treatment for Type 2 diabetes.
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2008.12.10 00:00
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GlaxoSmithKline PLC announced Dec. 8 it has received FDA approval of its vaccine Boostrix (tetanus toxoid, reduced diphtheria toxoid and absorbed acellular pertussis vaccine) for the use in adults, based on results of two clinical trials enrolling 3,000 patients. The vaccine received FDA approval before for the use in patients ages 10 to18 as a booster vaccine against tetanus, diptheria, and pertu
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2008.12.10 00:00
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Attorneys have filed a multi-million dollar lawsuit against drug giant Bayer Inc. because its drug Trasylol (aprotinin), which was given to patients to inhibit bleeding during cardiac surgery, has been linked to a higher risk of death. The class-action lawsuit claims that Bayer failed to adequately warn physicians and patients about the risks of the drug.
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2008.12.09 00:00
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In an article, published in the December issue of Pediatrics, researchers from Boston University report about the worrying common use of pseudoephedrine, found in many cough, cold, and allergy medicines, among children in the US. Particularly in the age group younger than two, with the highest risk for toxicity, the use should be according to safe dosing recommendations.
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2008.12.09 00:00
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An analysis by the University of Illinois-Chicago, published in the online edition of The Lancet, Dec. 5, of hundred fifty studies including more than 21,000 patients, rated the traditional division between first- and second-generation antipsychotic drugs not valid, because there are no advantages of the latter. Doctors should prescribe drugs on a patient-by-patient basis.
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2008.12.09 00:00
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During a hearing of the trial, set to begin in the District Court of Tampa, Florida Feb. 2, in which plaintiff claims she developed diabetes after using the antipsychotic Seroquel (quetiapine), company documents revealed that the drug maker knew of the risks as far back as 2000. AstraZeneca PLC faces more than 15,000 claims filed by consumers. From 2003 the FDA has required manufacturers to warn t
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2008.12.09 00:00
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Pfizer Inc., the largest pharmaceutical company in the world, is expected to announce a new round of layoffs in sales and marketing next month, as it works to cut costs before generic copies of its top-selling drug Lipitor (atorvastatin) will become available. The drug maker will probably announce its plans in January along with its 2009 earnings forecast.
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2008.12.09 00:00