Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Shots:The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in ChinaOpinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…

ByDipanshu DixitOctober 22, 2025

VIEWPOINTS

Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots

Shots: At ASH 2024, Regeneron shared data from the P-III exploratory cohort investigating the pozelimab and cemdisiran combination (poze-cemdi) in patients with paroxysmal nocturnal hemoglobinuria The novel combination (poze-cemdi) achieved meaningful control of intravascular hemolysis compared to ravulizumab PharmaShots welcomes Lorah Perlee, Vice President, Global Program Head, Hematology and Translational Sciences at Regeneron, for an…

BySaurabh ChaubeyJune 23, 2025

NEWS

Incyte’s Monjuvi Regimen Receives the US FDA Approval for R/R Follicular Lymphoma

Shots:The US FDA has approved Monjuvi (tafasitamab-cxix) + rituximab & lenalidomide for the treatment of adult pts with r/r follicular lymphoma (FL)Approval was based on the P-III (inMIND) trial assessing Monjuvi regimen vs PBO + rituximab & lenalidomide in adults (n=654) with r/r Grade 1 to 3a FL or r/r nodal, splenic or…

ByRidhi RastogiJune 19, 2025

NEWS

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

Shots:The EC has approved Calquence (acalabrutinib) + venetoclax ± Gazyva for the treatment of adults with 1L CLL; regulatory review is ongoing in other regionsApproval was based on the P-III (AMPLIFY) trial assessing Calquence regimen with or without Gazyva vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL pts without del(17p) or TP53 mutationTrial showed…

ByRidhi RastogiJune 6, 2025

NEWS

CRISPR Therapeutics Enters a Multi-Target Collaboration with Sirius Therapeutics to Develop Novel siRNA Therapies

Shots:CRISPR & Sirius have partnered to co-develop & co-market SRSD107, with CRISPR having the option to nominate ~2 siRNA targets, fund related research, & retain opt-in rights for clinical development & marketingAs per the deal, Sirius will receive $25M cash & $70M in equity upfront, with both companies jointly developing SRSD107 under a…

ByRidhi RastogiMay 20, 2025

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots

Incyte’s Monjuvi Regimen Receives the US FDA Approval for R/R Follicular Lymphoma

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

CRISPR Therapeutics Enters a Multi-Target Collaboration with Sirius Therapeutics to Develop Novel siRNA Therapies

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