Month: August 2018

MedImmune (AZ) reports results of TULIP 1 P-III for anifrolumab

Shots: TULIP 1 P-III trial with didn’t meet SRI4@12mos in moderate-to-severe SLE patients TULIP study includes two P-III trials TULIP 1 (N=460) in ratio (1:2:2) for 52 wks. administering of 150,300mg anifrolumab IV or PBO q4w; TULIP 2(N=373) in ratio (1:1) 300mg anifrolumab IV or PBO q4w, evaluating safety and efficacy Anifrolumab is also being […]Read More

FDA Reports Newly Added Guidelines for Drug and Device Makers

Shots: Opioid Abuse – Giving special priority to medication-assisted treatment(MAT) for patients to develop novel medicines for treatment of opioid use disorder encouraging drug sponsors to adapt new processes for evaluating effect and clinical benefit of MAT Depression– Plans to examine the onset of action of MDD for long-term or short- term usage; including those […]Read More

Vertex and Genomics plc forms a three-year collaboration extendable up

Shots: This collaboration plans to use human genetics and machine learning to address unmet needs by developing precision medicines Vertex will make £25M series B funding in Genomics (£10.5M equity investment) in addition to milestone and royalty payments from clinical developments to Genomics Genomics with its largest unique analysis engine having 100B data points linking […]Read More

BMS’s Sprycel (dasatinib) sBLA Receives Positive Response from the US

Shots:  This sBLA involves (Sprycel + CT) for the treatment of pediatric patients (≤17yrs) newly diagnosed with Philadelphia chromosome +ve ALL The application is based on the ongoing P-II CA180-372 (NCT01460160) trial evaluating (Sprycel + CT) modeled on a Berlin-Frankfurt-Munster high-risk backbone in patients with Ph+ ALL  Expected Action date by FDA is Dec 29, […]Read More

Roche’s Hemlibra P-III Positive results for Haemophilia A without factor

Shots: The data contains HAVEN 3 (N=152) study evaluating Hemlibra (emicizumab) prophylaxis vs no prophylaxis with patients aged ≥12 yrs HAVEN 3 results: (reduction in treated bleeds 96%/qw, 97%/q2w); (zero treated bleeds 55.6%/qw, 60%q2w); (three or fewer treated bleeds 91.7%qw, 94.3%q2w); (reduction in treated target-joint bleeds 95%) The US granted Hemlibra BT&PR designations for people […]Read More