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February 21, 2008
Eurand's NDA for Zentase was accepted and has been granted priority review by FDA. Gearoid Faherty, chief executive officer of Eurand, commented, "We are extremely pleased with the FDA decision to grant Zentase priority review. We understand tha…
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February 19, 2008
Abbott received approval from the FDA for Simcor, the first fixed-dose combination of cholesterol therapies, Niaspan (Abbott's niacin extended-release) and simvastatin. Simcor is approved for use along with diet to lower levels of elevated total chol…
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February 14, 2008
Biogen Idec and Cardiokine, Inc. initiated a Phase III study of lixivaptan for congestive heart failure patients who suffer from hyponatremia, which is an electrolyte disturbance marked by low sodium levels in the blood. The trial will compare treatm…
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February 1, 2008
Somaxon Pharmaceuticals, Inc. has submitted a NDA to the FDA for Silenor for the treatment of insomnia.The FDA is expected to make a decision within 60 days. If the NDA is accepted, the FDA will complete its review and provide an action letter within…
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January 30, 2008
Millennium’s Velcade was granted priority review from the FDA for patients with newly diagnosed multiple myeloma (MM). The sNDA for this indication included data from the Phase III VISTA study, a large, international trial, comparing a Velcade…
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January 29, 2008
Pfizer Japan, Inc. received manufacturing and marketing authorization for Champix Tablet 0.5 mg/1mg (varenicline tartrate), a smoking cessation aid for nicotine-dependent smokers.
Champix, Japan’s first oral smoking…
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January 16, 2008
Pfizer has submitted a NDA to the FDA for Fablyn (lasofoxifene tartrate) Tablets (formerly, Oporia), a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in postmenopausal women. Pfizer included three-year interim data fro…
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January 14, 2008
Merck and Schering-Plough's ENHANCE comparator trial for Vytorin did not meet its primary endpoint. The trial examined Vytorin—which combines the companies' drug Zetia (ezetimibe) with Merck's Zocor (simvastatin)—against Zocor alone in de…
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January 4, 2008
Daiichi Sankyo and Eli Lilly have submitted a NDA to the FDA for prasugrel, an oral antiplatelet agent initially in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (…
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January 3, 2008
Schering-Plough's NDA for sugammadex has been assigned priority review status by the FDA. Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the U.S. as Zemuron and vecuronium bromide, which are used a…
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January 2, 2008
AstraZeneca submitted two sNDAs to the FDA for once-daily Seroquel XR Extended-Release Tablets in the following indications: treatment of manic episodes associated with bipolar disorder and treatment of depressive episodes associated with bipolar dis…
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December 21, 2007
Abbott has received marketing authorization from the European Commission for the use of Humira as a treatment for moderate-to-severe plaque psoriasis. In one clinical trial, more than 80% of patients taking Humira achieved skin clearance of 75%…
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December 7, 2007
Janssen-Cilag has submitted an MAA for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The MAA was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State, and Austria, Fin…
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December 7, 2007
Seattle Genetics has begun a Phase IIb trial of SGN-40 in combination with Rituxan plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company's collaboration agreement with Genente…
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December 4, 2007
Two Johnson & Johnson subsidiaries, Centocor, Inc. and Janssen-Cilag International NV, have submitted marketing approval applications for ustekinumab (CNTO 1275) in the U.S. and Europe for the treatment of adult patients with chronic moderate to…
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