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Pharmasset Inc. said April 20 the development of its most advanced drug candidate, clevudine, will be halted because of concerns over severe muscle weakness. Hepatitis B patients enrolled in the late-stage QUASH studies in South Korea, trying the experimental drug, showed an alarming rate of myopathy cases. The firm will continue collecting safety data and monitoring patients after the study is d
제약단신
메디칼라이터팀
2009.04.22 00:00
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Sepracor Inc. said on April 17 that it discovered the drug Pristiq (desvenlafaxine), an antidepressant marketed by Wyeth, first and filed an application for a patent in April 1999, almost two years before Wyeth made its first filing in February 2001. The Board of Patent Appeals and Interferences of the US Patent and Trademark Office is expected to rule on who invented the drug first and who will h
제약단신
메디칼라이터팀
2009.04.21 00:00
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다중 심혈관계 위험인자 한알로 조절…맞춤 치료는 어려워2009 미국심장학회서 "TIPS" 연구로 주목 "One-size-fits-most", "Magic Bullet" 등의 애칭을 달고 "기적의 신약"으로 불리던 다중약물복합제 폴리필(Polypill)에 대한 임상데이터가 처음으로 보고됐다. 지난달 미국심장학회(ACC) 연례학술대회에서 발표된 "TIPS" 연구가 그 주인공. 단기간의 치료·관찰이 진행된 2상임상이었지만, 실체를 드러내지 않았던 폴리필의 심혈관위험인자 조절효과와 안전성 및 내약성에 대해 전반적으로 긍정적인 평가가 내려졌다. 폴리필은 동일한 질환의 예방·치료를 위해 여러 위험인자들을 타깃으로 하는 다양한 기전의 약물들을 하나의 정제에 섞은 복합알약 개념이다. 여러 약물을 별
순환기/뇌혈관
김수미 기자
2009.04.13 00:00
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CVD 치료전략 선택 하나 더 는 것TIPS 연구로 주목받는폴리필 폴리필 개발에는 고려해야 할 점들이 많다. 약물 간 상호작용, 부작용 위험과 정제 크기의 부담, 약물 방출시간 조절 등 기술적 요인들의 해결을 전제로 하고 있다. 여러 약물 주성분을 하나의 알약으로 만들어 안전하고 편하게 사용하는 것이 가능하겠냐는 의문들이 제기돼 왔던 것도 바로 이 때문.폴리필 개발 배경 서울대병원 심장내과 김효수 교수(대한심장학회 학술이사)는 폴리필 개발을 CVD 예방·치료동향 변화에 따른 당연한 귀결로 해석했다. 현재의 CVD 가이드라인은 과거와 비교해 크게 강화된 성격을 띠고 있다. 고혈압의 경우 과거 수축기혈압 150mmHg는 큰 문제가 아니었다. 140mmHg 역시 적절한 운동정도가 처방되는 수준이었다. 현재는
순환기/뇌혈관
이상돈 기자
2009.04.13 00:00
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The FDA reviewed Onglyza (saxagliptin), a new diabetes drug being developed by Bristol-Myers Squibb Co. and AstraZeneca PLC, for cardiovascular safety and analyzed 6 studies submitted by the companies. The reviewers found an overall low rate of cardiovascular events and in higher-risk patients, the rates appeared to be similar between patients taking saxagliptin and those getting a placebo or, in
제약단신
메디칼라이터팀
2009.04.01 00:00
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Arena Pharmaceuticals Inc. said March 30 that its experimental obesity treatment lorcaserin succeeded in reducing weight in a late-stage study, even though the results didn’t meet the FDA guidelines yet. Arena"s phase 3 clinical trial found that at 12 months 47.5% of patients taking lorcaserin lost at least 5% of their body weight, compared with 20% on placebo, but the weight-loss difference betw
제약단신
메디칼라이터팀
2009.04.01 00:00
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Ventracor Ltd, an Australian maker of heart pumps, went into voluntary administration last week, which, like bankruptcy protection in the US, can buy a company time to trade out of its financial difficulties. According to insiders in the market, almost half of Australia’s 130 publicly traded pharmaceutical and medical devices companies risk insolvency in the next year. Ventracor is the third and b
제약단신
메디칼라이터팀
2009.03.26 00:00
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The Novartis institute for tropical diseases, a non-profit joint venture between Novartis AG and the Singapore government, is looking to develop treatments for dengue, malaria and tuberculosis since its inception in 2002. Its aim is to have a drug against dengue fever ready for clinical trials on humans by 2011, after the initial plan of having 2 drugs in clinical trials by 2008 and a new drug on
제약단신
메디칼라이터팀
2009.03.24 00:00
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Cadence Pharmaceuticals Inc. announced on March 12 that the development of its catheter-related infection treatment Omigard (omiganan pentahydrochloride 1% aqueous gel) will be discontinued after it failed in a late-stage study. In a study involving almost two thousand patients, Omigard failed to prove superior to standard povidone-iodine treatment in the prevention of catheter-related infections.
제약단신
메디칼라이터팀
2009.03.16 00:00
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According to a study at the Children"s Hospital of Philadelphia, published in Pediatrics, many doctors don"t prescribe emergency contraception pills to adolescents because of misinformation. Investigators surveyed 291 members of the American Academy of Pediatrics Section of Emergency Medicine and found that more than 80% of the doctors had prescribed the pill less than 5 times a year and 43% of
제약단신
메디칼라이터팀
2009.03.11 00:00
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A study report of the gynecological Cancer Research Unit at University College London, published in the online edition of The Lancet Oncology, March 10, discusses the effectiveness of a combination of a blood test and an ultrasound scan in detecting ovarian cancer in its early and more curable stages. The study randomly assigned almost 203,000 postmenopausal women to either no ovarian cancer scree
제약단신
메디칼라이터팀
2009.03.11 00:00
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Until recently, there has been no known treatment for the, mostly fatal, ailments caused by the fruit bat viruses Nipah and Hendra, which were discovered in the nineties, when they jumped from animals to humans. In the last month however 2 scientist teams have separately discovered that the old malaria drug chloroquine may be effective against the deadly viruses.
제약단신
메디칼라이터팀
2009.03.11 00:00
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A study, published in the Canadian Medical Association Journal, reviewing data on 5,000 Quebec hospital patients, found that a pneumonia vaccine reduces the risk of heart attacks by almost 50%. Compared to patients who didn"t have heart attacks, those who did were much less likely to have received a pneumonia vaccine at least 2 years before they were hospitalized. Apparently the vaccine has certa
제약단신
메디칼라이터팀
2009.02.20 00:00
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A review of the US clinical trial registry by Duke University researchers, published in the New England Journal of Medicine, found that 157out of 509 Phase III trials, usually the largest and most significant trial in the development of a drug, were being conducted outside the US. Results of clinical trials can usually be obtained cheaper and faster in developing countries, because patients are wi
제약단신
메디칼라이터팀
2009.02.20 00:00
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A phase III study at the Centre Hospitalier Universitaire in Lille, France, published online in the Feb. 6 issue of Gut, finds adalimumab therapy, a human monoclonal antibody to tumor necrosis factor (TNF), more effective than placebo for inducing fistula healing in patients with active Crohn"s disease. Complete fistula healing was sustained for up to 2 years by most patients.
제약단신
메디칼라이터팀
2009.02.19 00:00
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Amgen Inc. and Takeda Pharmaceuticals, partners in the development of the cancer drug motesanib, announced that an independent monitoring committee recommended resuming clinical trials of motesanib almost 3 months after the trials were halted in November because of higher deaths among patients. The late-stage trials, which were evaluating motesanib for patients with non-squamous, non-small cell l
제약단신
메디칼라이터팀
2009.02.13 00:00
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The FDA warns that weight-loss capsules called StarCaps, promoted as natural dietary supplements using papaya, could be hazardous. One of the capsules ingredients was found to be a potent pharmaceutical drug called bumetanide which can have serious side effects. In a continuing investigation, the FDA has determined that dozens of weight-loss supplements, most of them imported from China contain hi
제약단신
메디칼라이터팀
2009.02.11 00:00
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The FDA ordered a change of label for 2 classes of depression treatment - selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). The labels of those drugs must from now on inform patients that malignant neuroleptic syndrome, a rare but dangerous and potentially fatal condition, may result from their use. This side effect is seen most often during
제약단신
메디칼라이터팀
2009.02.09 00:00
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A study by Allan Jensen and colleagues at the Danish Cancer Society, published online in the British Medical Journal, investigated the effects of the most widely used fertility drugs in 54,362 women referred to Danish fertility clinics between 1963 and 1998 and found no overall increased risk for ovarian cancer related to the use of any of the fertility drugs. The study is ongoing in order to see
제약단신
메디칼라이터팀
2009.02.08 00:00
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Researchers at the Institute of Child Health in London have found that two in thousand children is carrying a gene variation that turns them prone to hearing loss when using a common hospital antibiotic like aminoglycosides. Even normal doses of this antibiotic, widely used on children, can permanently harm hearing. Researchers recommend to genetically screen out groups of patients who will almost
제약단신
메디칼라이터팀
2009.02.06 00:00