Shots: Pfizer plans to hike in drug with 5% for 36 of its drug, 3% for three and 9% for one, will be implemented in Jan 2019 Additionally, the current […]readmore
Tags : US
Shots: Ferring to receive the US commercialization rights for INVOcell Technology and Invo will take care of its manufacturing and supplying activities for Ferring Invo has rights to establish INVO […]readmore
Shots: The global P-III HARMONIZE involves assessing of Lokelma (5/10mg) vs PBO in 267 patients with hyperkalaemia in Japan, Korea, Taiwan and Russia across 47 locations P-III HARMONIZE Results: @48 […]readmore
Biosimilars
Biotech
Regulatory
Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Accepted for Review
Shots: The BLA (Biologics License Application) has been accepted under the 351(k) pathway for SB5, which was filed by Samsung Bioepis in Jul 2018. Samsung Bioepis’ SB5 is already approved […]readmore
Shots: TGA approval is based on P-III reSURFACE data (N=1862) i.e. (reSURFACE 1 and reSURFACE 2) assessing Ilumya 100mg vs PBO or etanercept, showing PASI 75 reduction in psoriasis severity […]readmore
Shots: Results of P-III ODYSSEY OUTCOMES assessing PRALUENT(alirocumab) IV (N= 18,924), having an acute coronary syndrome (ACS), such as a heart attack, b/w 1-12 mos before being enrolled The US […]readmore
Shots: Principia files IPO with $86mn having ticker PRNB Principia’s lead product PRN1008 (BTKi) with Ph III & II for pemphigus and immune thrombocytopenic purpura respectively In 2017, Principia collaborated with […]readmore