|Basilea's partner Astellas receives notification from US FDA of acceptance of ...|
Mucormycosis (also known as zygomycosis) is an often lethal fungal infection caused by certain emerging molds. Mucormycosis is associated with high morbidity and mortality rates in immunocompromised patients such as patients undergoing chemotherapy ...
PharmiWeb.com (press release) - Sat, 06 Sep 2014 06:07
|Astellas' Antifungal Under FDA Review, Response by Mar 2015 - Analyst Blog|
Astellas Pharma, Inc. ( ALPMY ) and partner Basilea Pharmaceutica announced that the FDA has accepted their new drug application (NDA) for isavuconazole. The companies are looking to get isavuconazole approved for the treatment of invasive ...
NASDAQ - Mon, 08 Sep 2014 14:11
|US FDA accepts Astellas' NDA filing for Isavuconazole to treat invasive ...|
pharmabiz.com - Tue, 09 Sep 2014 01:26
|New antifungal drug effective against invasive mold disease in cancer patients ...|
A newly developed antifungal, isavuconazole, is as effective as an existing drug, voriconazole, against invasive mold disease in cancer patients with less adverse effects, according to phase 3 clinical data presented at the 54th Interscience Conference ...
News-Medical.net - Mon, 08 Sep 2014 02:00
|Astellas to Showcase Isavuconazole Data at ICAAC|
Astellas has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are life-threatening fungal ...
MarketWatch - Fri, 05 Sep 2014 09:03
|Extensive data presented on Basilea's anti-infectives isavuconazole ...|
NASDAQ - Thu, 04 Sep 2014 22:15
|Basilea To Receive Milestone Payment From Astellas - Quick Facts|
The NDA seeks approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis, also known as zygomycosis, in adults. In accordance with the FDA Prescription Drug User Fee Act, the FDA designated the date of March 8, ...
NASDAQ - Sat, 06 Sep 2014 05:33
|Astellas Receives Notification from FDA of Acceptance of Filing of ...|
NEWS.GNOM.ES - Sat, 06 Sep 2014 05:11
|European Medicines Agency accepts Basilea's isavuconazole Marketing ...|
... European Medicines Agency (EMA) has accepted its isavuconazole Marketing Authorization Application (MAA) for review. Basilea's MAA seeks approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
MarketWatch - Wed, 20 Aug 2014 22:22
|Astellas-Basilea's Isavuconazole Accepted for EU Review - Analyst Blog|
Astellas Pharma, Inc. ( ALPMY ) and partner Basilea Pharmaceutica's isavuconazole has been accepted for review in the EU. The companies are looking to get isavuconazole approved in the EU for the treatment of invasive aspergillosis and mucormycosis ...
NASDAQ - Thu, 21 Aug 2014 14:00
|EMA agrees to review Basilea's isavuconazole marketing authorization application|
Pharmaceutical Business Review - Fri, 22 Aug 2014 08:11
|Industry Trend Analysis - Astellas Outperforms In Q114 - OCT 2014|
The FDA designated Astellas' isavuconazole as a qualified infectious disease product (QIDP) for the treatment of invasive candidiasis. Previously, isavuconazole received QIDP designation for invasive aspergillosis and invasive mucormycosis (zygomycosis).
Pharmaceuticals & Healthcare Insight (registration) - Fri, 05 Sep 2014 22:37