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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…
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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)…
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BI & Re-Vana Therapeutics have entered into a strategic collaboration & license agreement to develop extended-release therapies for eye diseases
As per the deal, BI will obtain target exclusivity, while Re-Vana will receive over $1B in total potential deal value for the initial 3 targets, incl. upfront, development, regulatory, & commercial milestones, plus royalties…
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LEO Pharma has entered into an exclusive global license & transfer agreement with BI to commercialize & advance the development of Spevigo (spesolimab)
As per the deal, LEO Pharma will handle commercialization & further development of Spevigo in exchange for $105.18M (€90M) upfront, along with milestones & tiered royalties; closing expected in H2’25, subject…
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ViVerita Therapeutics & BI have entered into a strategic research collaboration to accelerate discovery & validation of novel cancer targets. Although financial terms of the deal were not disclosed
As per the deal, ViVerita will utilize its in vivo CRISPR discovery platform to study selected potential targets from BI, evaluating their functions in physiologically relevant…
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BI & Cue Biopharma have entered into a multi-year strategic research & license agreement to develop & commercialize CUE-501 for autoimmune diseases, with the potential to expand into other B cell-targeting bispecifics using Cue’s Immuno-STAT platform
As per the deal, Cue Biopharma will receive a $12M upfront & ~$345M in research, development, & commercial…
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BI has launched Vaxxitek HVT+IBD+H5, a trivalent poultry vaccine against marek’s disease, infectious bursal disease & H5 avian influenza; commercially available in Egypt by Feb 2025
Trivalent vaccine uses BI's COBRA tech to create unique antigen for protection against prevalent H5 clades & is administered at the hatchery for early chick protection to avoid…

