Shots:
The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review
Approval was based on the P-III (IRAKLIA) study in R/R…
NEWS
Shots:
Boltz has partnered with Takeda to deploy its biomolecular AI platform across Takeda’s research organization, providing discovery teams access to proprietary foundation models, incl. BoltzMol-1 & BoltzProt-1, to accelerate AI-driven drug discovery
The platform is designed to support in-silico molecular design, enabling structure prediction, affinity estimation, and generative design to enhance AI-driven drug discovery…
Shots:
Voro Therapeutics & Alloy Therapeutics have entered into a strategic research collaboration to discover and develop next-generation masked T-cell engager (TCE) therapies
Partnership will combine Voro’s PrimeBody platform with Alloy’s optimized CD3 antibodies & multispecific engineering capabilities to develop novel immunotherapies designed to selectively activate immune responses within tumors
PrimeBody is designed to unlock difficult-to-target…
Shots:
The MHLW has approved Minjuvi (tafasitamab) + Lenalidomide for the treatment of adult pts. with r/r diffuse large B-cell lymphoma (DLBCL)
Approval was based on the international P-II (L-MIND) trial, & a Japanese P-Ib/II (J-MIND) trial (Group 6) assessing Minjuvi + lenalidomide in pts with r/r DLBCL who are not eligible for autologous stem…
Shots:
The US FDA has expanded the indication for Capvaxive to incl. pts aged 2–17yrs. with certain chronic medical conditions who have completed a primary pediatric pneumococcal vaccination series & remain at increased risk of pneumococcal disease
Approval was supported by P-III (STRIDE-13) trial data, which compared Capvaxive with PPSV23 in the above-mentioned pts
Capvaxive…
Shots:
The US FDA has received an NDA for ecopipam, a selective dopamine D1 receptor antagonist, for the treatment of pediatric Tourette syndrome
NDA was supported by the P-III trial data showing that ecopipam significantly delayed time to relapse vs PBO in pediatric Tourette syndrome pts who responded to treatment during the open-label treatment period;…
Shots:
The US FDA has accepted sBLA for Genentech's Lunsumio VELO (mosunetuzumab-axgb; SC) + Polivy (polatuzumab vedotin-piiq) for treating adults with r/r LBCL, incl. diffuse large B-cell lymphoma (DLBCL), after ≥1L of systemic therapy (PDUFA: Feb 9, 2027)
sBLA was backed by the P-III (SUNMO) study assessing Lunsumio VELO + Polivy (IV) vs R-GemOx in the above…
Shots:
Samsung Bioepis & Organon have expanded their development & commercialization agreement for Pyzchiva, a biosimilar version of Stelara (ustekinumab), with launch expected in 2026
As per the deal, Organon will gain exclusive commercialization rights to Pyzchiva in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, & regulatory activities.
The addition of Pyzchiva expands the…
Shots:
F2G & Shionogi have reported the topline P-III (OASIS) trial data assessing olorofim (PO) vs AmBisome followed by SoC in 225 pts with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy
Trial met its 1EP of non-inferiority, with a rate of all-cause mortality of 23.8% vs 24.3% at Day 42,…
Shots:
LabGenius has entered into a multi-year research collaboration, option & licensing agreement with LG Chem to identify next-generation multispecific antibodies for difficult-to-treat cancers, leveraging LabGenius’ AI/ML-driven antibody discovery platform, EVA
As per the licensing deal, LabGenius will lead preclinical research, incl. in vitro efficacy studies, after which LG Chem will conduct further preclinical development, incl.…

