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P-III trial of survodutide (3.6 or 6mg, QW) in 755 pts, met both co-1EP using treatment-regimen & efficacy estimands. At Wk. 76, weight loss reached up to an average of 13.1% vs 3.1% with PBO, while up to 79.3% vs 32.7% pts achieved ≥5% weight loss (efficacy estimand)
In 2EPs, trial showed reduced HbA1c…
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Variant Bio has expanded its multi-year research collaboration & license agreement with BI to discover and validate novel cardiovascular disease targets using its Inference platform, building on their existing kidney disease collaboration
As per the terms of the expanded agreement, Variant Bio will receive an additional upfront payment & over $250M in potential license…
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Envisagenics has entered a multi-year research collaboration & option agreement with BI to validate tumor-specific targets for developing first-in-class precision therapies for solid tumors, using Envisagenics’ AI-powered SpliceCore platform
Collaboration builds on targets identified through SpliceCore to validate their potential across ADCs, TCEs & multispecific Abs, with BI having an option to exclusively license…
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The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.
EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
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Merck & Co., Roche, and Johnson & Johnson emerged as the leading pharmaceutical companies by R&D expenditure in 2025, investing $15.78B, $15.49B, and $14.66B, respectively. Continued investments in late-stage clinical programs, pipeline expansion, advanced technologies, and strategic business development reinforced their commitment to driving pharmaceutical innovation
Global biopharmaceutical R&D investment continues to accelerate as…
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The EC has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) & adults with progressive pulmonary fibrosis (PPF)
Approval was based on the P-III (FIBRONEER) program, comprising the FIBRONEER-IPF & FIBRONEER-ILD trials. Both met their 1EP, demonstrating that Jascayd slowed lung function decline, measured by the change in FVC…
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BI has entered into a strategic research collaboration with Combotope to leverage its SMART-Phage platform to produce highly tumor-selective antibodies for next-generation cancer therapies
Combotope will discover tumor-selective, high-affinity antibodies against multiple BI oncology targets, while BI will hold global development & commercialization rights, and lead further R&D, manufacturing, & commercialization activities
As per…
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The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.
CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
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The NMPA has granted conditional approval to Hernexeos (zongertinib) for initial treatment of adults with unresectable, locally advanced, or metastatic NSCLC harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations
Approval was based on the data from a treatment-naïve cohort (N=74) of P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75.7% (10.8%…
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The CHMP has recommended Jascayd (nerandomilast) for the treatment of adults with IPF and PPF
Opinion was supported by the P-III (FIBRONEER-IPF and FIBRONEER-ILD) trials; both trials met their 1EPs, showing nerandomilast slowed lung function decline vs PBO through Wk-52. Nerandomilast also demonstrated a favorable safety/tolerability profile, with no liver monitoring requirement and PBO-like discontinuation rates as monotx.
Jascayd (PO, BID) is a PDE4B inhibitor with antifibrotic and…

