BC Week In Review | Aug 3, 2015
Clinical News

Cresemba isavuconazonium: Phase III data

The double-blind, international Phase III ACTIVE trial in 440 patients with candidemia and other invasive Candida infections showed that IV isavuconazole missed the primary endpoint of non-inferiority to IV Cancidas caspofungin in overall treatment response...
BC Extra | Mar 7, 2015
Company News

FDA approves antifungal Cresemba

FDA approved an NDA from Astellas Pharma Inc. (Tokyo:4503) for oral and IV Cresemba isavuconazonium sulfate to treat adults with invasive aspergillosis and mucormycosis. The broad-spectrum water-soluble azole antifungal was under Priority Review, and has...
BC Week In Review | Jan 26, 2015
Clinical News

Cresemba isavuconazonium regulatory update

FDA’s Anti-Infective Drugs Advisory Committee backed approval of Cresemba isavuconazonium from Astellas to treat invasive aspergillosis and mucormycosis in adults. The committee voted 11-0 that Astellas provided substantial evidence of Cresemba’s safety and efficacy for...
BC Extra | Jan 23, 2015
Company News

FDA panel backs Astellas-Basilea antifungal

FDA's Anti-Infective Drugs Advisory Committee on Thursday backed approval of Cresemba isavuconazonium ( BAL8557 ) from Astellas Pharma Inc. (Tokyo:4503) to treat invasive aspergillosis and mucormycosis in adults. The committee voted 11-0 that Astellas provided substantial evidence...
BC Extra | Jan 21, 2015
Company News

FDA briefing docs benign for Astellas, Basilea antifungal

FDA reviewers offered little commentary on Cresemba isavuconazonium ( BAL8557 ) from Astellas Pharma Inc. (Tokyo:4503) in voriconazole . In the 516-patient double-blind Phase III SECURE trial for aspergillosis, isavuconazole met the primary endpoint of non-inferiority to voriconazole...
BC Week In Review | Oct 27, 2014
Clinical News

Isavuconazole: Phase III ongoing

Basilea said it will amend the double-blind, international Phase III ACTIVE trial of isavuconazole to reduce enrollment to 438 patients from 526. The company said a recent blinded assessment of interim data showed a higher...
BC Week In Review | Oct 7, 2013
Clinical News

Isavuconazole: Phase III data

Top-line data from the double-blind, international Phase III SECURE trial in 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi showed that once-daily isavuconazole met the primary endpoint of non-inferiority...
BC Extra | Oct 1, 2013
Top Story

Basilea's isavuconazole meets in Phase III

Basilea Pharmaceutica AG (SIX:BSLN) and partner Astellas Pharma Inc. (Tokyo:4503) said once-daily isavuconazole met the primary endpoint of non-inferiority to twice-daily voriconazole in reducing all-cause mortality from baseline to day 42 (18.6% vs. 20.2%) in...
BC Innovations | Sep 12, 2013
Cover Story

TLR4 signaling in allergic asthma

Baylor College of Medicine researchers have uncovered a pathway in allergic asthma that opens up the potential for developing therapeutics that target the causes of the disease rather than just its symptoms. 1 The team...
BC Week In Review | Jul 22, 2013
Clinical News

Isavuconazole: Phase III amended

Basilea said the time point to assess the primary endpoint of overall response was amended in the double-blind, international Phase III ACTIVE trial of IV and oral isavuconazole to the end of IV treatment from...
Items per page:
1 - 10 of 46