Tags : Expanded Use

Regulatory

Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use

Shots: The EC approval is based on P-III UNIFI program [induction study (8wks. IV) & maintenance study (44wks., SC, q8w & q12w)] assessing Stelara vs PBO in patients with mod. to sev. active UC with inadequate response to conventional (corticosteroids, immunomodulators) or biologic (one or more TNF-alpha antagonists/vedolizumab) therapies Induction study results: Clinical response achievement […]Read More

Pharma Regulatory

Janssen’s Imbruvica (ibrutinib) Receives CHMP Positive Recommendation for its Expanded

Shots: The CHMP’s positive opinion for CLL is based on P-III iLLUMINATE (PCYC1130) study assessing Imbruvica + obinutuzumab vs chlorambucil + obinutuzumab in patients with newly diagnosed CLL, resulted in longer m-PFS The CHMP’s positive opinion for WM is based on P-III iNNOVATE (PCYC-1127) study evaluating the ibrutinib & rituximab vs rituximab + PBO in […]Read More