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news.EU to review Ark’s MAA for brain cancer drug
Cerepro was originally filed for marketing approval under exceptional circumstances in late 2005 and was reviewed by the European Medicines Regulatory Agency (EMEA) with reliance on Phase II
Cerepro was originally filed for marketing approval under exceptional circumstances in late 2005 and was reviewed by the European Medicines Regulatory Agency (EMEA) with reliance on Phase II
The collaboration which has been renewed several times and initiated in December 2002 focuses on the identification, development and commercialization of drugs for the treatment of neurodegenerative diseases,
An Independent Data Monitoring Committee (IDMC) has evaluated the interim results and concluded that the benefit-risk profile of zalutumumab is acceptable. The IDMC recommended that the trial should
The two Phase II, randomized, double-blind, placebo-controlled, dose-ranging studies enrolled a total of 157 patients and were conducted across 10 centers in the UK, Canada, and Australia. Multiple
The proposed indication in the marketing authorization application (MAA) is for the prevention of seasonal influenza. The MAA submission for live attenuated influenza vaccine (LAIV) is based on
Approved by the FDA under an investigational device exemption (IDE), the superficial femoral artery (SFA) study is a prospective, multicenter, single-arm trial planned to enroll 178 subjects at
The console powers Medtronic’s Midas Rex Legend EHS and Legend EHS Stylus drills, used primarily in spinal and cranial applications, and the Straightshot M4 Microdebrider, Visao, and Skeeter
Under the terms of the agreement, MicroDose will fund the development of prototypes based upon MicroDose’s inhaler platform and incorporating Nexus6’s SmartinhalerLive technology. MicroDose will receive an option
Under the terms of the agreement, S*BIO is eligible to receive up to $550 million in combined equity purchase, option and license fees, and development and sales milestone
Seppro depletion products enable scientists to measure more precisely the expression of protein biomarkers from a range of mammalian and plant biological samples. This acquisition covers current inventory,