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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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수석문화재단은 12일 동아제약 본사에서 2009학년도 장학증서 수여식을 가졌다. 강신호 이사장(동아제약 회장)과 민건식 이사(한국피해자학회 명예회장), 최종고 이사(서울대학교 법과대학 교수), 백광현 감사(변호사), 이재술 감사(딜로이트 안진회계법인 대표이사) 등이 참석해 올해 선발된 장학생 29명(대학생 20명, 고등학생 9명)에게 장학증서를 수여했다.수석문화재단은 1987년 출범 이후 총 1432명에 장학금을 지원해 왔으며 장학사업 외에 학술분야 지원 및 문화사업을 지원하고 있다.한편 수석문화재단은 1987년 5월 13일 동아제약 강신호 회장이 회갑을 맞이 타인을 위해 일할 줄 아는 책임 있는 인재를 육성하기 위해 설립한 수석장학회를 동아제약 창립 60주년이 되는 1992년에 발전적으로 개편한 재단법인이
제약바이오
하장수
2009.08.12 00:00
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녹십자는 세계보건기구와 신종 인플루엔자 바이러스에 의한 전세계적 팬데믹 상황에 적극 대응하기 위해 팬데믹 인플루엔자 백신 개발을 위한 공동연구 계약을 체결했다고 12일 밝혔다.이에 따라 녹십자와 WHO는 향후 5년간 팬데믹 인플루엔자 백신에 대한 연구 및 개발을 위해 상호 협력하게 된다. WHO는 백신 연구 및 임상시험을 위한 협력과 재정적 지원을 하고 녹십자는 백신 생산을 위한 연구 및 공정 개발을 담당하게 된다.이병건 부사장은 "이번 계약 체결로 WHO와의 협력관계가 더욱 긴밀해 지는 동시에 녹십자의 글로벌 백신 연구개발에 초석이 될 것"이라고 밝히고 "국내의 팬데믹 인플루엔자에 대한 방어뿐만 아니라 아시아 팬데믹 인플루엔자 방어에도 기여하게 될 것"이라고 했다.마리-폴 키니 WHO 팬데믹 백신 프로그램
제약바이오
하장수
2009.08.12 00:00
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한국얀센은 12일 "프릴리지의 허가를 위해 식약청에 제출한 한국인 대상 임상시험 결과 조루 진단 기준에 포함되는 문제들을 모두 개선시키는 것으로 나타났다"고 밝혓다.한국얀센은 "임상 참여 전 평균 1.2분이었던 사정시간이 프릴리지 복용 후 30mg군은 4분으로 3.4배, 60mg군은 4.5분으로 3.8배 증가했다"고 설명하고 "첫 복용부터 통계적으로 유의한 사정지연 효과와 용량 의존적으로 효과가 증가하는 결과를 보였다"고 했다.또 "사정조절능력의 경우 10%를 넘지 못하던 매우 좋다와 좋다라고 답한 비율이 임상 종료시점에는 70%에 육박했으며 스트레스, 배우자와의 관계, 성관계 만족도 등 조루가 미치는 부정적 영향도 임상초기(4주)부터 통계적으로 유의한 개선 효과를 나타냈다"고 소개했다.특히 "조루가 미치는
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2009.08.12 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
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한국신약개발연구조합은 다음달 7일, 14일, 15일 3일간의 일정으로 서울대학교 호암교수회관 컨벤션센터 무궁화홀에서 회원사 및 제약업계, 바이오테크기업, 대학, 연구기관 관계자를 대상으로 제 2기 제약산업, 바이오기술분야의 라이센싱 및 오픈이노베이션 기술마케팅 전문가 양성 고급과정을 개설한다. 이번 고급과정은 국내 제약 기업이 글로벌 초우량기업으로 성장하기 위해서 필수적으로 요구되는 파이프라인 강화 및 연구 성과의 효과적인 사업화를 추진할 글로벌 비즈니스 전문가의 지속적인 양성을 위해 연구조합이 글로벌 컨설팅사인 영국 SDS Group과 함께 개설한 것이다. 5개 모듈 11개 프로그램으로 구성되며 교육 참가자에게는 교재와는 별도로 국내 미 공개된 각종 학습자료 및 실전에 활용할 수 있는 Case Materi
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하장수
2009.08.11 00:00
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Researchers are working on at least three experimental vaccines to prevent ear infections in children under five which is the leading reason for prescribing antibiotics in the US. The eustachian tube of a child"s middle ear is short, floppy, and prone to collecting fluid that can foster bacteria and some children undergo surgery implanting ear tubes that often fall out. Although there are more th
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2009.08.11 00:00
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The shareholders of both companies have both overwhelmingly backed Merck & Co."s acquisition of Schering-Plough Corp., a deal that allows Merck, the world"s eighth-biggest drugmaker by prescription medicine sales, to jump to second just behind Pfizer. Merck has its asthma and allergy treatment Singulair [montelukast] and cervical cancer vaccine Gardasil while Schering-Plough can contribute its a
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2009.08.11 00:00
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General Electric seeks FDA approval of Datscan, its drug that assists in the detection of the neuron deterioration in the brain, which is linked to diseases like Parkinson"s, dementia, and related problems but according to the FDA submitted data from studies does not clearly support its use in patients undergoing brain scans to detect these nervous system disorders. The drug binds to brain protei
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2009.08.11 00:00