Shots:
Boehringer Ingelheim and CDR-Life signed a global licensing deal to develop CDR111, a trispecific M-gager T-cell engager targeting and depleting B cells to help reset the immune system in autoimmune diseases
As per the deal, CDR-Life could receive up to CHF 456M (~$570M), including CHF 38M (~$ 48M) upfront and near-term payments, plus tiered…
Shots:
BI has licensed a pre-clinical small molecule program from Kyowa Kirin to develop it as a potential treatment for autoimmune diseases
As per the deal, BI will receive exclusive rights to develop the small molecule program globally, expanding BI’s inflammatory pipeline
In contrast, Kyowa Kirin will receive up to €640M (~$744.4M), incl. an upfront payment, development,…
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The NMPA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in Japan & the EU, with further filings planned
Approval was based on P-III (FIBRONEER-IPF) assessing Jascayd (18 or 9mg, PO, BID) vs PBO in IPF pts, which met its 1EP of reduced FVC decline at…
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BI has entered into a global collaboration & licensing agreement with AimedBio to develop a novel ADC for a broad range of cancers, expanding NBE Therapeutics’ portfolio (BI subsidiary)
As per the deal, AimedBio will receive ~$991M, incl. an upfront, development & regulatory milestones, plus commercial milestones, as well as net sales-based royalties
AimedBio’s…
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The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia
Trial met its 1EP with 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., achieving a Cohen’s D of -0.36; most…
Shots:
The US FDA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in China, Japan, & the EU, with further filings planned
Approval was based on P-III (FIBRONEER-IPF) & P-II (Trial 2) trials, where FIBRONEER-IPF assessed Jascayd (18 or 9mg, PO, BID) vs PBO in…
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China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy
Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS…
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Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being
The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
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BI has entered into a global research collaboration and licensing agreement with Palatin Technologies to develop novel melanocortin receptor agonist for retinal diseases
As per the deal, Palatin is eligible for ~$327.6M (€280M) in upfront, development, regulatory, & commercial milestone payments, along with tiered royalties on net sales
Collaboration strengthens Boehringer’s retinal pipeline by…
Shots:
The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy
Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

