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Extavia [interferon beta-1b] Novartis AG"s multiple sclerosis treatment, a copy of Bayer AG"s Betaseron [interferon beta-1b] has been approved by the FDA. The drug allows the company to establish itself within the multiple sclerosis field prior to launching its FTY720 MS pill.
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2009.08.18 00:00
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Saphris [asenapine], Schering-Plough Corp."s new drug for schizophrenia and bipolar disorder, has been approved by the FDA and it is the first mind-altering treatment to be approved simultaneously for both conditions. The medication is taken twice daily and dissolves under the tongue. FDA approval was based on data from more than 3,000 patients. Both conditions showed statistically significant im
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2009.08.18 00:00
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According to a report published in the journal Cell, the drug salinomycin, cut the number of stem cells at least 100 times more than did Bristol-Myers Squibb Co."s, Taxol [paclitaxel]. Some researchers believe that cancerous stem cells are responsible for tumor growth and that these cells are highly resistant to chemotherapy. Standard chemotherapy treatments kill 99 percent of cells in a tumor le
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2009.08.17 00:00
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An FDA advisory committee voted 15 to 0 that denosumab, Amgen"s new bone drug, should be approved to treat postmenopausal women with osteoporosis, at the same time it voted 12 to 3 that denosumab should not be approved to prevent osteoporosis in women with moderately low bone mineral density. The panel voted against three of the four possible uses of the drug for breast and prostate cancer patien
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2009.08.17 00:00
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Following reports that Mylan was conducting an internal investigation at its West Virginia plant into whether its employees were bypassing computer generated warnings, the FDA"s has closed its inspection satisfied that the audit trails were intact for each instance where the software was overridden by the operator, and it has closed its report. The FDA seems satisfied that the company is providi
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2009.08.17 00:00
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King Pharmaceuticals Inc. has been granted FDA approval for its drug, Embeda, a morphine painkilling drug, which may not easily be crushed to get the full dose at once as there is a chemical present in the capsule that counteracts the effect of the morphine. According to an FDA spokeswoman, "the prescribing information and medication guide will include data about two studies that show no evidence
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2009.08.17 00:00
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Dr. John A. Baron, a professor of medicine at Dartmouth Medical School, along with other medical experts, advises patients to consult a physician before starting a daily regimen of aspirin due to the risks of gastrointestinal bleeding, hemorrhagic strokes, or bleeding in the brain following reports suggesting that aspirin may increase survival chances for colorectal cancer patients. According to D
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2009.08.14 00:00
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An experimental treatment reported in a paper online in Nature Medicine, called GIFT15, was shown to put multiple sclerosis into remission by suppressing the immune response that attacks the central nervous system in mice. The animals with the mouse model MS, an experimental autoimmune encephalomyelitis, experienced no adverse effects. The drug is composed of two proteins that are fused in the lab
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2009.08.14 00:00
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A Washington court dismissed Astellas" challenge of the FDA"s denial of the company"s petition on Prograf (tacrolimus). The company petitioned for tests proving the safety and efficacy of such drugs and for the requirement that doctors are notified whenever a substitute oral medicine is about to be provided to a transplant patient.
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2009.08.14 00:00
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The World Health Organization stressed that the antiviral drug Tamiflu should be used in severe and progressive cases of swine flu but that it should not be given to those showing mild flu-like symptoms despite a study which warned against use by children.
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2009.08.14 00:00
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In new rules that were posted on the FDA"s website drugmakers will be ale to give or sell experimental medicines to patients who have no other options. The regulations clarifies existing programs as well as expanding the access to such drugs to additional groups of patients. One of the rules enables companies to charge patients for the experimental drugs although in doing so they must prove that
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2009.08.14 00:00
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Data from two ongoing studies of 1,300 patients with colorectal cancer, the Nurses" Health Study and the Health Professionals Follow-up Study, was analyzed by Harvard scientists with researchers at Massachusetts General Hospital and the Dana-Farber Cancer Institute. After 12 years, the study"s end, 193 (35 percent) deaths and 81 (15 percent) colorectal-cancer-associated deaths were recorded amon
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2009.08.13 00:00
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The FDA extended the review period for Prevnar 13 by 90 days to Dec. 30 after Wyeth sent the agency additional information about analysis of and specifications on the physical and chemical properties of the drug. According to Wyeth, the FDA has not asked for further studies but the agency needs more time to review data that demonstrates that production will be consistent over time. The vaccine pro
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2009.08.13 00:00
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Hospira Inc. has FDA approval for a generic version of Eloxatin [oxaliplatin] while Teva Pharmaceutical Industries Ltd. has commenced selling the generic. The drug is approved to treat advanced colon cancer and stage III colon cancer following surgery. Meanwhile Sun Pharmaceutical Industries Ltd. has received FDA approval to manufacture and sell it and shares 180 days of marketing exclusivity for
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2009.08.13 00:00
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The FDA has expressed concern regarding denosumab"s effect on the immune system. The Amgen Inc. drug is designed to inhibit a protein that is involved with bone destruction known as RANK Ligand, it also plays a role in the body"s immune system. According to the FDA clinical trials of the drug showed higher rates of serious infections including skin infections that required hospitalization and ce
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2009.08.13 00:00
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In two studies research has indicated that Amgen Inc."s genetically engineered osteoporosis drug, denosumab, could reduce the risk of bone fractures more effectively than alternative medications that are available today including the brand-name Fosamax [alendronate] pill and estrogen . The drug is given twice a year as an injection under the skin. A study of 7,800 women 60-90 years old with oste
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2009.08.13 00:00
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Cardiome Pharma Corp. and Astellas Pharma Inc. will enroll patients with recent-onset atrial fibrillation who don"t have a history of heart failure in a study for their drug Kynapid (vernakalant). The late-stage trial is scheduled to be completed in the first half of 2011. The study comes after the drug has been delayed by the FDA twice last year.
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2009.08.12 00:00
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Genzyme Corp."s decision to discard 80 percent of the material it had on hand to produce the enzyme disorder drug, Cerezyme [imiglucerase], will cause longer delays in production but the company has issued guidelines which will preserve full doses for patients under 18 and those suffering from the most severe versions of Gaucher disease. According to the company the Boston facility which was clos
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2009.08.12 00:00
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Astellas Pharma Inc.plans to challenge an FDA decision which the company says lowers the bar for generic makers to begin developing their own versions of tacrolimus [Prograf], and file a complaint at the US District Court. The company requested the FDA to take steps to change the labels on oral immune system drugs, known as immunosuppressants, or ensure that companies developing such drugs conduct
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2009.08.12 00:00
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In a review of research published in the British Medical Journal the antivirals, Tamiflu [oseltamivir] or Relenza [zanamivir], should not be given to children under the age of 12 to treat suspected swine flu. According to Dr. Matthew Thomson, one of the authors, the drugs only shorten the length of illness by a few days and that there is a need for a greater understanding of how the drugs work in
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2009.08.12 00:00