Orthofix Medical, a global medical device company focused on musculoskeletal healing products, announced it has received the US Food and Drug Administration (FDA) 510(k) clearance and European CE Mark approval for the JuniOrtho Plating System. Created specifically for pediatric patients, this innovative fixation system is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.
Enforcement Report - Week of November 6, 2019
Mylan`s Prasugrel Receives Approval In Europe
Mylan Pharm’s Generic Prasugrel (Prasugrel Hydrochloride) Receives Approval In US
The Big Pharma had staffed up in anticipation of a solanezumab approval, planning to hit the streets with information on the potential blockbuster as soon as it could be launched. The drug had been a hotly anticipated new treatment for Alzheimer’s, a disease that is growing rapidly in the U.S. as the population ages.
Daiichi Sankyo Company, Limited, announced the results of phase 3 clinical trials in Japan of the antiplatelet agent prasugrel hydrochloride (prasugrel) for ischemic cerebrovascular disease patients.nThe PRASTRO-I study was conducted in 3,747 ischemic cerebrovascular disease patients, excluding cardiogenic cerebral embolisms, aged 75 years and under and weighing more than 50 kg to verify non-inferiority in efficacy of prasugrel administered once daily in a 3.75 mg dose compared to the once daily administration of a 75 mg dose of clopidogrel. In this study, the primary endpoint of reduction of cerebro-cardiovascular events (ischemic stroke, myocardial infarction or other vascular death) was not achieved. Additionally, no new concerns for the safety of prasugrel were observed.
The cardio sector continues to roll out new treatments to keep our blood pumping smoothly, cholesterol at bay and CV risk at a minimum. And as it does, marketers are striving to find a balance between brands already nestled in the market and the highly anticipated wave of cardio products ready to ink invitations to their launch parties.
FDA reviewer backs approval of TMC`s cangrelor