Prasugrel receives CHMP nod
This article was originally published in Scrip
The EU's CHMPhas granted a positive opinion recommending approval of LillyandDaiichi Sankyo's novel antiplatelet therapy prasugrel (Efient, 5mg and 10mg film-coated tablets), giving a boost to the product which has twice seen delays in its US approval process. In Tokyo, shares in Daiichi Sankyo surged by nearly 6% on the news on December 19th, regaining some of the ground lost since September when the FDA failed to complete its review by the PDUFA user fee deadline.
You may also be interested in...
The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.
Executives On The Move: BioXcel Therapeutics Picks A Development Officer, A Finance Hire At RenovaCare And CANbridge Taps Takeda Talent
Immuno-oncology and neuroscience firm BioXcel Therapeutics picks a chief development officer, and stem-cell therapy company RenovaCare hires a CFO. Plus, CANbridge Life Sciences, developer of specialty health products, adds Takeda Pharma rare disease lead as global head, business development.
Topline Phase II data for the antibody-drug conjugate tisotumab vedotin put it on a swift path towards approval in cervical cancer.