TrueLab Inks ~$985M Deal with Bionyra to Advance Two Immune-Mediated Inflammatory Disease Therapies

Shots: TrueLab has granted Bionyra exclusive worldwide rights, excl. Greater China, to research, develop, manufacture, & commercialize TL-001, an anti-TL1A monoclonal antibody, & TL-003, a TL1A × IL-23p19 bispecific antibody As per the deal, TrueLab will receive ~$985M in total consideration, incl. an upfront payment as well as development, regulatory, & commercial milestone payments, with tiered…

ByRidhi RastogiJune 23, 2026

NEWS

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

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…

ByRidhi RastogiJune 19, 2026

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Takeda Partners with Boltz to Advance AI-Driven Drug Discovery

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…

ByRidhi RastogiJune 19, 2026

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Voro Therapeutics and Alloy Therapeutics Partner on Next-Generation T-Cell Engagers

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…

ByRidhi RastogiJune 19, 2026

NEWS

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

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…

ByRidhi RastogiJune 19, 2026

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The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

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…

ByRidhi RastogiJune 19, 2026

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Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

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;…

ByRidhi RastogiJune 19, 2026

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Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

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…

ByRidhi RastogiJune 18, 2026

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Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada

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…

ByRidhi RastogiJune 18, 2026

NEWS

F2G and Shionogi Report Topline P-III (OASIS) Trial Results on Olorofim in Invasive Aspergillosis

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,…

ByRidhi RastogiJune 18, 2026

Ridhi Rastogi

TrueLab Inks ~$985M Deal with Bionyra to Advance Two Immune-Mediated Inflammatory Disease Therapies

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Takeda Partners with Boltz to Advance AI-Driven Drug Discovery

Voro Therapeutics and Alloy Therapeutics Partner on Next-Generation T-Cell Engagers

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada

F2G and Shionogi Report Topline P-III (OASIS) Trial Results on Olorofim in Invasive Aspergillosis

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