-
"급성심정지 위험 불구 필요 환자 인정" 미국식품의약국(FDA) 자문위원회는 급성심장사 부작용으로 FDA의 검토를 받은 정신분열증 치료제 세르틴돌(sertindole, Serdolect)의 승인을 추천하기로 결정했다. 하지만 안전성 문제에 있어서는 "적합하지 않다"라는 투표 결과가 나와 "일부 환자"들에게만 적용되는 것으로 결정했다. FDA는 세르틴돌이 정신분열증에는 효과가 있지만 현재 사용되고 있는 리스페리돈(risperidone, Rispedal)과의 비교연구에서 급성 심장사가 각각 13명, 4명으로 나타나 위험도가 약 5배가량 높다고 검토결과를 발표했다. FDA 자문위원회도 투표에서 12대 1로 일반적인 정신분열증 환자가 사용하기에 안전하지 않다는 의견에 동의했다. 이와 함께 화두에 오른 것은
제약단신
김수미 기자
2009.04.13 00:00
-
[International Journal of Clinical Practice, 2009;63-547-559]= "백지장도 맞들면 낫다." 콜레스테롤 관리도 여기서 예외는 아니었다. 이제티마이브(ezetimibe)와 심바스타틴(simvastatin) 병용요법이 로수바스타틴(rosuvastatin) 단독요법보다 LDL 콜레스테롤과 총콜레스테롤 수치 등의 감소에 추가적인 부작용 없이 더 효과적인 것으로 나타났다. 프랑스 포인트 의대(Point Medical) 파르니에(Michel Farnier) 교수팀은 심혈관질환 고위험군에 해당하는 고지혈증 환자 618명을 대상으로 이제티마이브 10㎎과 심바스타틴 20㎎ 병용요법군(314명)과 로수바스타틴 10㎎ 단독요법군(304명)으로 나눠 6주 동안 총콜레스테롤 수치
제약단신
김수미 기자
2009.04.13 00:00
-
Sanofi-Aventis announced on April 9 it plans to buy Medley, the third largest pharmaceutical company and number 1 generic company in Brazil, for €500 million ($662.8 million). The acquisition is expected to close in the second quarter and will make Sanofi-Aventis into Latin America"s top generics manufacturer.
제약단신
메디칼라이터팀
2009.04.13 00:00
-
In 2007 and 2008, two conferences for Asian new drug development were held in Tokyo. For this third conference, active colleagues from other Asian countries (China, Chinese Taipei and Republic of Korea) joined in the program committee and selected locally based issues. Main topics will be “Epidemiological Research and Market Needs in Asian countries” “Asian Clinical Trials” and “Ask the Asian Regu
제약단신
메디칼라이터팀
2009.04.10 00:00
-
An FDA panel unanimously voted on April 8 against making AstraZeneca’s schizophrenia medication Seroquel (quetiapine) drug of choice to treat depression, because of its worrisome side effects such as diabetes, tardive dyskinesia, metabolic and heart risks. The panel said however in a 6-3 vote that the medication could be useful as a supplemental therapy for patients who are not cured with other an
제약단신
메디칼라이터팀
2009.04.10 00:00
-
A study conducted at 19 participating medical centers, published in the April 9 issue of the New England Journal of Medicine, investigated the effects of acid reflux medication in asthma patients and found that among 412 patients with poorly controlled asthma, the group given Nexium (esomeprazole) twice a day for half a year, fared no better in symptom control than patients getting placebo. Till n
제약단신
메디칼라이터팀
2009.04.10 00:00
-
Genentech Inc., unit of Roche Holding AG, said on April 8 to voluntarily withdraw its psoriasis drug Raptiva (efalizumab) from the market after it was linked with progressive multifocal leukoencephalopathy (PML), a rare but fatal brain disorder. The company said it made this decision together with the FDA, which approved Raptiva for patients with chronic moderate to severe plaque psoriasis in 2003
제약단신
메디칼라이터팀
2009.04.10 00:00
-
Infinity Pharmaceuticals Inc. is developing a number of cancer treatments and has a schedule that includes selling its first drug by 2012, as well as having three other treatments in trials by that time. The Wall Street Journal remarks that even though many small drug companies seek to survive the current financial crisis, Infinity has cash to last it through 2012 and has every intention of sellin
제약단신
메디칼라이터팀
2009.04.09 00:00
-
Britain"s NICE, the regulatory agency that advises the UK government in healthcare issues, decided last year that Sutent (sunitinib) was too expensive to be offered, because the drug doesn’t cure, only prolongs survival. The decision drew sharp criticism from cancer patients and as a result, the government gave in to public pressure. Life prolonging drugs can now be allowed if they extend life by
제약단신
메디칼라이터팀
2009.04.09 00:00
-
A trial that included 18 patients with ovarian cancer, at the Centre for Experimental Cancer Medicine at the London School of Medicine and Dentistry, investigated a drug named CNTO328 and found that the drug slowed down the cancer progress. During the course of the trial the tumors in 8 women remained the same or shrank and 7 of those women are still alive. The drug is known that its action is sim
제약단신
메디칼라이터팀
2009.04.09 00:00
-
Cephalon Inc. said on April 6 to get ready to apply for US regulatory approval for Nuvigil (armodafinil) as a treatment for jet lag by the third quarter. The company said the drug proved successful in preventing jet lag during a late-stage study. Currently Nuvigil has been approved to treat several sleep disorders and is an updated version of Provigil (modafinil).
제약단신
메디칼라이터팀
2009.04.08 00:00
-
The FDA requested on April 6 more information from AstraZeneca PLC in order to establish the appropriate dosage of the drug for the requested age group. The company applied for approval in February to sell the drug for children aged 6 to 11. Symbicort is already approved in the US for the treatment of asthma in children of 12 and older.
제약단신
메디칼라이터팀
2009.04.08 00:00
-
In the process of applying for FDA approval for exenatide LAR (long-acting release) in the coming months, Amylin Pharmaceuticals is trying to support the safety image of its diabetes drug Byetta (exenatide), saying no risks of cancerous tumors have been noted with its use. Wall Street analysts however cautioned investors that exenatide LAR approval may be delayed by additional thyroid studies requ
제약단신
메디칼라이터팀
2009.04.08 00:00
-
According to an FDA review, the antipsychotic drug candidate Serdolect (sertindole) is effective at treating schizophrenia, but it may lead to sudden cardiac death, because of its potential to prolong the heart"s QT interval. The same cardiac risk has been seen in other antipsychotic drugs. The Psychopharmacologic Drugs Advisory Committee will meet on April 7 to discuss if the drug"s risks form
제약단신
메디칼라이터팀
2009.04.08 00:00
-
Bristol-Myers Squibb Co. is extending its deal to share revenue and split costs with Japan"s Otsuka Pharmaceutical Co. regarding the psychiatric drug Abilify (aripiprazole), that Otsuka discovered. Under the agreement Bristol-Myers will receive a 30-month extension on Abilify till 2015 in return for a payment of $400 million. In addition, the companies agreed to share revenue and marketing for 2
제약단신
메디칼라이터팀
2009.04.08 00:00
-
The FDA said on April 3 it is concerned about allowing expanded use of AstraZeneca PLC"s Seroquel (quetiapine) because of possible increased risks of heart problems. The drug is currently approved to treat bipolar disorder and schizophrenia. AstraZeneca applied for approval to sell an extended-release version of Seroquel to treat generalized anxiety disorder and major depression.
제약단신
메디칼라이터팀
2009.04.07 00:00
-
Teva Pharmaceutical Industries Ltd. said April 2 it started selling copies of Shire PLC"s attention deficit/hyperactivity disorder drug Adderall XR (amphetamine, dextroamphetamine mixed salts) in the US. Shire made a deal with Barr Pharmaceuticals, which is now owned by Teva, in 2006 that allows to start selling generic versions of the drug before the patent expired.
제약단신
메디칼라이터팀
2009.04.07 00:00
-
Dendreon Corp. said it will wait until new data is received on its experimental prostate cancer drug Provenge (sipuleucel-T), before giving a commitment to present at the American Urological Association on April 28 in Chicago. The late-stage study, called IMPACT, includes the final data that Dendreon needs to apply for FDA approval of the drug, which was delayed in 2007.
제약단신
메디칼라이터팀
2009.04.07 00:00
-
Apotex Inc., a Canadian generic drugmaker, seems to have received US regulatory approval to sell copies of AstraZeneca Plc"s asthma drug Pulmicort (budesonide), according to information on the FDA’s website. The FDA approval comes as a surprise for AstraZeneca’s investors, after the company’s settlement with Teva Pharmaceutical Industries last year over the same issue . AstraZeneca filed a patent
제약단신
메디칼라이터팀
2009.04.07 00:00
-
In a first action against internet promotion, the FDA sent out official warnings to Roche Holding AG, Merck & Co., Bayer AG, Johnson & Johnson, Forest Laboratories Inc., Eli Lilly & Co., Boehringer Ingelheim GmbH, Genentech Inc., GlaxoSmithKline PLC and Novartis AG about internet ads that usually pop up when people use search engines to check health problems and type in a disease or product name.
제약단신
메디칼라이터팀
2009.04.07 00:00