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Pfizer’s Velsipity (etrasimod) Receives the European Commission’s Approval for the Treatment of Severely Active Ulcerative Colitis 
Shots:   The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma   Patients in the trial have previously received 1-3 prior lines of therapy,…
Mabwell Highlights Results from the P-III Study of MW032 (biosimilar, denosumab) for Solid Tumors in JAMA Oncology 
Shots:  The results from the P-III trial comparing MW032’s (SC, Q4W, until wk. 49) safety, efficacy & PK vs reference drug (denosumab) to treat patients (n=708), randomized 1:1, with solid tumors having bone metastasis are published in JAMA Oncology  The 1EP includes percentage change in natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr) from baseline to…
Biocon Biologics Enters into a Collaboration Agreement with Sandoz for the Commercialization of Ogivri (biosimilar, trastuzumab) and Abevmy (biosimilar, bevacizumab) to Treat Cancer 
Shots:   Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications   Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia…
Rani Therapeutics Reports the Results for RT-111 Capsules Containing CT-P43 (biosimilar, ustekinumab) in P-I Trial for the Treatment of Various Indications
Shots:   The P-I clinical trial evaluates the safety & efficacy of RT-111 in delivering CT-P43 (biosimilar, ustekinumab) in patients with moderate to severe plaque psoriasis, active psoriatic arthritis & IBD  As per the results, RT-111 delivered CT-P43 in a dose proportional manner with high bioavailability & depicted a higher Cmax & shorter Tmax vs ustekinumab…
Astellas
Astellas Receives the EMA’s Validation on Type II Variation Application for Padcev (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) to Treat Advance Bladder Cancer
Shots The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety The results depicted that the study met its…