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스마젠(대표 김동준)은 에이즈백신 후보물질 SAV001의 본격적인 인체 대상 임상 시험을 위해 29일 미국 FDA에 IND 신청을 했다고 밝혔다.스마젠의 에이즈 백신 후보 ‘SAV001’은 캐나다 Western Ontario 대학 강칠용 박사팀이 사백신을 활용해 개발한 것으로 2005년 원숭이 실험 성공에 이어 2008년 cGMP 대량생산 성공, 2009년 전임상 시험 등이 완료된 상태이다.회사는 "미국 FDA IND 신청은 인체를 대상으로 하는 임상시험 허가를 받기 위한 것으로서 이제 스마젠의 에이즈백신 후보 SAV001이 본격적인 임상시험에 돌입하게 되었음을 의미한다"고 전하고 "미국 FDA가 IND 신청을 승인하는 데로 임상 1상 시험을 착수할 예정"이라고 했다.또 "임상 1상 시험은 미국 내 임상시험
제약바이오
하장수
2009.06.30 00:00
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Research published in the journal Nature show that rapamycin seemed to boost the number of "memory" T cells that remember the infections they have encountered before. The study, involving tests on mice and monkeys, also suggests that the protein, mTOR plays a key role in regulating the generation of memory T cells and according to Professor Adrian Hill, director of the Jenner Institute, could be
제약단신
메디칼라이터팀
2009.06.30 00:00
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The Obama administration supports legislation that generic drugs should be protected from competition for 7 years. The industry has said it wants 12-14 years but according to the the Federal Trade Commission delay innovation and patients" access to cheaper drugs. This compomise is of interest to Debra Barrett, vice-president for government affairs at Teva Pharmaceuticals (TEVA). The company has
제약단신
메디칼라이터팀
2009.06.30 00:00
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Roche has stopped selling its acne drug Accutane [isotretinoin]as sales have fallen since its patent expired in 2002. Roche maintains that the decision was made for economic reasons as generic versions are now on the market although the drug has also been the subject of several lawsuits. The company has been faced with high costs from personal injury. Juries awarded $33 million in damages to users
제약단신
메디칼라이터팀
2009.06.30 00:00
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환자 따라 혈당조절 속도·강도 달리해야 최근의 미국당뇨병학회(ADA) 연례 학술대회에서 발표된 "ACCORD"·"VADT" 연구 재분석 결과가 관심을 끌고 있다. 두 연구는 제2형당뇨병 환자에서 A1C 목표치 7%보다 낮게 정상범위로까지 혈당조절 시 심혈관사건 예방효과를 검증한 대표적 사례다. 결과가 예상에서 크게 벗어나면서 혈당조절 전략을 둘러싼 열띤 논쟁을 야기한 장본인이기도 하다. A1C 6% 대로 혈당을 조절한 그룹이 기존 수치를 목표한 대조군 대비 심혈관사건 예방에 차이가 없거나 사망위험을 증가시키는 결과가 파생된 것. "ACCORD" 연구가 중단되면서 과도한 사망위험을 설명하기 위한 추가분석들이 신속하게 진행됐다. 하지만 임상현장의 혼선을 단번에 풀어줄 시원한 해답은 제시되지 못했다
순환기/뇌혈관
이상돈 기자
2009.06.29 00:00
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The European Medicines Agency has recommended gradually withdrawing dextropropoxyphene-containing painkillers, from the market, such as Darvon and Darvocet, as they have been linked to fatal overdose. The EMEA has not clarified how many people have died either accidentally or intentionally. In the US the drug is known by the generic name propoxyphene. Advisers to the FDA suggested removing it fro
제약단신
메디칼라이터팀
2009.06.27 00:00
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The Food and Drug Administration says Tylenol [acetaminophen] is safe if taken at recommended levels. Federal regulators and medical experts will debate how to limit liver injury in patients who take the medicines next week. Consumers are unaware that the same ingredients are prevalent in pain relievers, fever reducers, and cough medicines. If they are taking a variety it can lead to accidental ov
제약단신
메디칼라이터팀
2009.06.27 00:00
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Results of a study of 169 patients suffering from pancreatic islet cell tumors were presented at the World Congress on Gastrointestinal Cancer. Participants were randomized and either received 37.5mg/day of Sutent [sunitinib] or placebo. All participants had progressed over the previous 12 months and were receiving the best care. According to results patients treated with Pfizer"s drug, Sutent,
제약단신
메디칼라이터팀
2009.06.27 00:00
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The ActHIB and Pentacel Hib vaccines by Sanofi Pasteur are now available so the FDA recommend children be given their Haemophilus influenzae type B (Hib) booster doses which have been delayed due product suspension of Merck"s PedvaxHIB and Comvax. The company had received warnings that it breached manufacturing rules between November 2007 and January 2008 at its West Point, PA plant. All infants
제약단신
메디칼라이터팀
2009.06.27 00:00
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The Advisory Committee on Immunization Practices (ACIP) has examined guidelines post rabies exposure after hearing that out of 20-40 thousand Americans exposed around 1,000 get three-four doses of the vaccine instead of the usual five doses. The panel recommended four doses of the vaccine be given as none of the estimated 1,000 patients developed rabies, also, until earlier this year there have be
제약단신
메디칼라이터팀
2009.06.26 00:00
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Following its approval by the FDA in November, the Drug Administration and Drug Enforcement Agency (DEA) has ruled Johnson & Johnson"s drug, Nucynta [tapentadol], a schedule II drug, saying users may become psychologically or physically dependent. The DEA has accepted its medical use in treating moderate to severe acute pain in patients 18 and older. The prescription drug is available in 50 mg,
제약단신
메디칼라이터팀
2009.06.25 00:00
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According to the Federal Trade Commission, legislation preventing branded drug companies paying settlements to delay entry of the generic form into the market, could save American consumers $35 billion dollars, of which $12 billion would go to the government. A bill to prevent these settlements has been referred to the Senate. Pharmaceutical Research and Manufacturers Association has said that if
제약단신
메디칼라이터팀
2009.06.25 00:00
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According to a study, men taking nonsteroidal anti-inflammatory drugs (NSAIDs) daily show a reduction of around 50 percent in enlargement of the prostate gland whilst another study shows a 10 percent reduction in the PSA level. Both attribute results to NSAIDs anti-inflammatory properties but patients should be warned that kidney problems and liver toxicity could occur if NSAIDs are taken in exce
제약단신
메디칼라이터팀
2009.06.23 00:00
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Ilaris has been approved for sale by the Food and Drug Administration. The drug, developed by Novartis, treats cryopyrin-associated periodic syndrome (CAPS) which is a rare genetic disorder caused by a mutation in a single gene resulting in an oversupply of interleukin-1. which leads to inflammation and tissue damage, chronic rash, fever and joint pain. Novartis AG conducted trials in CAPS patient
제약단신
메디칼라이터팀
2009.06.21 00:00
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Matrixx Initiatives Inc. stopped selling Zicam nasal spray and swabs on June 16 after The Food and Drug Administration found 800 consumer complaints during a routine inspection. The company did not report the consumer concerns, according to the company"s president, as they were given legal advice in 2007 that they were not required to do so. The products did not require FDA approval when they we
제약단신
메디칼라이터팀
2009.06.21 00:00
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Sanofi CEO Chris Viehbache has offered 10 percent of its pandemic flu vaccine production and discount further orders to developing countries. The World Health Organization has asked manufacturers to assist those on low incomes and contribute to a "stockpile". Novartis AG has said that it would not contribute whilst GlaxoSmithKline will donate 50 million doses. WHO has said that 76 countries have
제약단신
메디칼라이터팀
2009.06.19 00:00
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An FDA panel has recommended that Krystexxa should get approval although the drug has been associated with higher rates of heart problems compared with placebo. Its intended use is for 50,000 Americans with severe gout and who cannot be treated with other drugs according to the drug"s maker, Savient. The FDA will rule on Krystexxa by July end and if approved is expected to recommend further safet
제약단신
메디칼라이터팀
2009.06.18 00:00
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The Food and Drug Aministration has told Matrixx to cease the sale of its zinc nasal gels and swabs due to reports of anosmia. William Hemelt, Matrixx"s acting president and chief operating officer said that this is not a new issue and that the company has studied it for years. There have been 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, according to
제약단신
메디칼라이터팀
2009.06.18 00:00
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Caldolor (produced by Cumberland Pharmaceuticals) has been approved by the US Food and Drug Administration to treat pain and fever. It will be available for use in hospitals only, in 400 milligram to 800 milligram doses. This is the first injectable form of ibuprofen and according to the FDA is useful in patients who are unable to take ibuprofen orally. In the phase III trials it was shown that pa
제약단신
메디칼라이터팀
2009.06.16 00:00
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New labels have been called for on popular asthma drugs like Merck"s Singulair [montelukast]. This follows the review of data by the FDA on clinical trials submitted by the manufacturers of Singulair, Accolate [zafirlukastand] and Zyflo [zileuton]. The trials did not indicate any changes in behavior but they were not designed to examine mood changes or suicidal behavior. By April 2009 further inv
제약단신
메디칼라이터팀
2009.06.16 00:00