Shots: The EU approval is based on results of P-III PROSPER trial assessing Xtandi+ ADT vs. PBO + ADT in patients with nmCRPC and PSA level The P-III PROSPER trial […]readmore
Tags : receives
Shots: The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs. P-II/III EXPRESS study results: @2 wks. change in […]readmore
Shots: The approval is based on 1EP analysis of 87 subjects involved in IDE study enrolling 37.9% female & 71.3% patients with systemic diseases, testing its safety and efficacy in […]readmore
Shots: The label update includes dosing flexibility of Cosentyx up to 300 mg based on clinical response & SC structural data of 24 wks., showing inhibition in progression of joint […]readmore
Shots: The approval is based on P-III CAPSTONE-1 study assessing Xofluza vs PBO or oseltamivir 75 mg (bid for 5days) in the US & Japan (N=1436) and P-II study in […]readmore
Shots: The ODD is based on Omeros’ P-III program assessing OMS721 in patients with HSCT-TMA. Additionally, OMS721 is being evaluated in ongoing P-III program for IgA nephropathy, and aHUS respectively […]readmore
Regulatory
Compass Pathways’ Psilocybin Therapy Receives FDA’s Breakthrough Therapy Designation for
Shots: The FDA’s BT designation follows clinical study assessing Psilocybin in 19 patients with treatment resistant depression, conducted at Imperial College London in 2015 FDA’s BT designation is granted to […]readmore
Shots: The US approval is based on MOMENTUM 3 trial results enrolling 1000 patients with NYHA Class IIIB or IV heart failure for a short-term endpoint of six months and […]readmore
Biosimilars
Regulatory
Mylan & Biocon Receive CHMP Recommendation to Ogivri (trastuzumab, biosimilar)
Shots: The CHMP recommendation will be reviewed by EU with expected closure in H2’18. In 2017, FDA approved Ogivri a novel biosimilar to Herceptin with additional regulatory approval in 35 […]readmore
Regulatory
Catalyst’s Firdapse (amifampridine) Receives FDA’s Approval for Lambert-Eaton Myasthenic Syndrome
Shots: The approval is based on two clinical trial results assessing Firdapse vs PBO in 64 patients with Lambert-Eaton Myasthenic Syndrome The study measured Quantitative Myasthenia Gravis score (assessing muscle […]readmore