Boehringer Ingelheim Reports Promising Results for SIRP Inhibitors in Cancer Immunotherapy Trials
• Boehringer Ingelheim's SIRP inhibitor BI 765063, when combined with PD-1 inhibitor ezabenlimab and cetuximab, showed manageable safety and promising antitumor activity in patients with recurrent/metastatic head and neck cancer.
• The company's next-generation SIRP inhibitor, BI 770371, demonstrated good tolerability both alone and in combination with ezabenlimab in patients with advanced solid tumors, with no dose-limiting toxicities observed.
• Both antibodies work by blocking the "don't eat me" signal cancer cells use to evade immune detection, potentially enabling immune cells like macrophages to better recognize and destroy tumor cells.
FTC Issues New Warnings to Teva and Novartis Over Improper Orange Book Patent Listings
• The Federal Trade Commission has renewed challenges against Novartis, Teva, and other pharmaceutical companies for allegedly improper patent listings in the FDA's Orange Book.
• The disputed listings involve more than 200 patents across 17 brand-name products, primarily for asthma, diabetes, epinephrine autoinjectors, and COPD medications.
• According to the FTC, these improper device patent listings may delay generic competition, artificially inflate drug prices, and restrict patient access to affordable medications.
BioMed X and Boehringer Ingelheim Launch Initiative to Revolutionize Retinal Drug Delivery
• BioMed X and Boehringer Ingelheim have announced a global call for proposals to develop next-generation intraocular biologics, marking their second research initiative at the XSeed Labs incubator in Ridgefield, Connecticut.
• The collaboration aims to address a critical challenge in retinal disease treatment by creating biologics with extended intraocular half-life and improved retinal penetration, potentially reducing the burden of frequent injections for patients.
• Selected researchers will develop a novel screening platform for biologics, explore innovative design principles, and validate promising technologies to significantly improve patient adherence and treatment outcomes.
Brainomix's e-Lung AI Technology Validated for Progressive Pulmonary Fibrosis Detection in Boehringer Ingelheim Collaboration
• New studies presented at the American Thoracic Society Conference validate Brainomix's FDA-cleared e-Lung technology as a reliable tool for identifying progressive pulmonary fibrosis with greater sensitivity than conventional methods.
• The validation studies utilized data from Boehringer Ingelheim's landmark INBUILD clinical trial, demonstrating e-Lung's ability to predict disease progression and patient outcomes independent of traditional CT imaging markers.
• Brainomix's AI-powered imaging solution enables earlier treatment decisions and better patient prioritization, potentially addressing the critical diagnostic delay that affects pulmonary fibrosis patients who often wait up to two years for diagnosis.
Datavant Acquires Aetion to Create End-to-End Real-World Evidence Platform
• Datavant has signed an agreement to acquire Aetion, combining two industry leaders to create a comprehensive real-world evidence platform that will accelerate healthcare decision-making across the clinical and commercial lifecycle.
• The strategic acquisition will unite Datavant's health data connectivity platform with Aetion's advanced analytics capabilities, serving an expanded ecosystem of over 300 data partners and enabling scientifically validated evidence accepted by global regulators.
• The combined company will enhance data discovery, linkage, privacy, and analysis capabilities, allowing life sciences companies to more efficiently answer critical research questions about therapeutic impacts both during development and post-market.
AbbVie and ADARx Form $335 Million Collaboration to Develop Next-Generation siRNA Therapies
• AbbVie has invested $335 million upfront in a strategic collaboration with ADARx Pharmaceuticals to develop small interfering RNA therapeutics across neuroscience, immunology, and oncology.
• The partnership combines ADARx's proprietary RNA technology for precise mRNA silencing with AbbVie's expertise in antibody engineering, ADCs, and tissue delivery approaches to overcome siRNA targeting challenges.
• Beyond the initial payment, ADARx is eligible to receive billions in additional contingent payments including milestone payments and tiered royalties as the collaboration advances.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.
• The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success.
• This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
Appeals Court Rejects AstraZeneca's Challenge to Medicare Drug Price Negotiation Program
• The 3rd U.S. Circuit Court of Appeals dismissed AstraZeneca's lawsuit against Medicare's drug price negotiation program, ruling the company failed to demonstrate specific injury or due process violations.
• The Medicare negotiation program, established under the Inflation Reduction Act, affects AstraZeneca's diabetes drug Farxiga, with negotiated prices set to take effect next year for 66 million Medicare beneficiaries.
• While AstraZeneca's challenge was rejected, a separate lawsuit by PhRMA and other pharmaceutical companies was revived by the 5th Circuit Court in September, creating conflicting judicial responses to industry challenges.
Boehringer Ingelheim Launches Phase II Trial of First-in-Class Oral Treatment for Geographic Atrophy
• Boehringer Ingelheim has initiated the JADE Phase II clinical study to evaluate BI 1584862, a potential first-in-class oral treatment for geographic atrophy, a severe form of age-related macular degeneration.
• Geographic atrophy affects over 5 million people worldwide with more than 40% considered legally blind, creating a significant unmet need for treatments that can slow disease progression and preserve vision.
• The company is simultaneously advancing a second compound, BI 771716, an antibody fragment designed to penetrate retinal layers, demonstrating Boehringer's dual-pathway approach to addressing this debilitating eye condition.
Tempus AI, AstraZeneca, and Pathos AI Form $200M Collaboration to Build Oncology Foundation Model
• Tempus AI has announced strategic collaborations with AstraZeneca and Pathos AI to develop a multimodal foundation model in oncology, with agreements totaling $200 million in data licensing and model development fees.
• The partnership will leverage Tempus' de-identified oncology data repository to build an AI model that can gather biological insights, discover novel drug targets, and develop therapeutics to improve cancer patient care globally.
• This collaboration expands on the existing 2021 partnership between Tempus and AstraZeneca, aiming to accelerate oncology R&D and increase the probability of clinical success across AstraZeneca's pipeline.
Roche and Zealand Pharma Forge $5.3 Billion Partnership to Develop Novel Obesity Treatments
• Roche has entered into a $5.3 billion collaboration with Zealand Pharma to co-develop petrelintide, a promising amylin analog for obesity treatment, both as monotherapy and in combination with Roche's incretin asset CT-388.
• The partnership includes upfront payments of $1.65 billion to Zealand Pharma, with profits and losses to be shared 50/50 in the US and Europe, while Roche gains exclusive commercialization rights for the rest of the world.
• Clinical data suggests petrelintide could deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability, potentially addressing unmet needs in the obesity market that is projected to affect 4 billion people globally by 2035.
Four New Humira Biosimilars Launch in US Market with Steep Discounts up to 85%
• Multiple pharmaceutical companies including Organon, Samsung Bioepis, Sandoz, and Boehringer Ingelheim launched Humira biosimilars in July 2023, offering significant price reductions compared to the original drug.
• Boehringer Ingelheim's Cyltezo becomes the first FDA-approved interchangeable biosimilar to Humira, allowing direct substitution without requiring prescription changes.
• The biosimilar launches come as AbbVie's Humira faces declining sales, with international revenues dropping 25% in Q1 2023 following the drug's $200 billion lifetime sales.
Tempus AI Reports Strong Growth and Strategic Acquisition of Ambry Genetics in Q4 2024
• Tempus AI completed the acquisition of Ambry Genetics on February 3, 2025, positioning the company for significant expansion in precision medicine and AI-driven healthcare solutions.
• The company launched its FDA-approved NGS-based diagnostic device, xT CDx, which received Advanced Diagnostic Laboratory Test status with a reimbursement rate of $4,500 per test.
• Tempus projects approximately $1.24 billion in revenue for 2025, representing 79% annual growth, and expects to achieve $5 million in Adjusted EBITDA, a $110 million improvement over 2024.
FDA Grants Priority Review to Boehringer's Zongertinib for HER2-Mutant Advanced Lung Cancer
• Boehringer Ingelheim's zongertinib could become the first oral targeted therapy for previously treated HER2-mutant advanced non-small cell lung cancer, with FDA decision expected in Q3 2025.
• Phase Ib trial demonstrated impressive 71% objective response rate in 75 previously treated NSCLC patients, with favorable safety profile and low treatment discontinuation rate.
• The drug addresses a significant unmet need in HER2-mutant NSCLC patients, who currently face poor prognosis with limited treatment options and less than 30% five-year survival rate.
Novel Oral Psoriasis Therapies Show Promise: TYK2 Inhibitors Lead Breakthrough Advances
• Deucravacitinib demonstrates superior efficacy over apremilast in psoriasis treatment, with over 53% of patients achieving significant skin clearance at week 16.
• Apremilast maintains its position as a key therapy for mild-to-moderate psoriasis, with 21% of bio-naïve patients achieving treatment goals in the ADVANCE trial.
• Next-generation oral therapies, including JNJ-77242114 and zasocitinib, show promising results in clinical trials, potentially expanding treatment options for psoriasis patients.
Japan Approves Groundbreaking Viral Therapy Teserpaturev for Glioblastoma Treatment
• Japan's health ministry committee has approved Teserpaturev, the country's first virotherapy drug developed by Daiichi Sankyo, marking a significant breakthrough in cancer treatment.
• The novel therapy, which uses modified herpesvirus to selectively target and destroy brain cancer cells, demonstrated a remarkable 92.3% one-year survival rate in clinical trials.
• The treatment, designed for malignant glioma patients with recurring tumors, showed a median survival period of 20 months, substantially exceeding traditional treatment outcomes.
Boehringer Ingelheim's Iclepertin Fails to Meet Endpoints in Phase III Schizophrenia Trials
• Boehringer Ingelheim's iclepertin, a GlyT1 inhibitor, failed to demonstrate statistically significant benefits in improving cognitive function in schizophrenia patients.
• The Phase III CONNEX program, involving over 1,800 patients across 41 countries, did not meet primary or key secondary endpoints at six months.
• As a result of the disappointing outcomes, Boehringer Ingelheim has discontinued the CONNEX-X long-term extension trial.
• The company remains committed to developing solutions for serious mental illnesses, with over 20 investigative therapies in its pipeline.
Akero's Efruxifermin Shows Promise in Reversing Cirrhosis Due to MASH in Phase 2b Trial
• Akero Therapeutics' Efruxifermin (EFX) demonstrated statistically significant cirrhosis reversal in patients with MASH in a Phase 2b trial.
• In patients with baseline and week 96 biopsies, 39% treated with 50mg EFX showed cirrhosis reversal without worsening MASH, compared to 15% with placebo.
• The SYMMETRY study underscores the benefit of longer EFX treatment, showing a doubling of effect size from weeks 36 to 96 in the 50mg group.
• Akero is continuing to evaluate 50mg EFX in the Phase 3 SYNCHRONY Outcomes study for patients with compensated cirrhosis due to MASH.
FDA Approves Bayer/Merck & Co Heart Failure Drug Verquvo
The FDA has approved Bayer and Merck & Co's heart failure drug, Verquvo (vericiguat), for reducing the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45%. This approval introduces a new option in a competitive market, following the results of the pivotal phase 3 VICTORIA trial.
FDA Approves Farxiga for Heart Failure with Reduced Ejection Fraction, Regardless of Diabetes Status
• The FDA has approved AstraZeneca's Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with reduced ejection fraction.
• This approval makes Farxiga the first SGLT2 inhibitor approved to treat heart failure with reduced ejection fraction (HFrEF) in patients both with and without type 2 diabetes.
• The decision was based on the DAPA-HF trial, which demonstrated a statistically significant 26% reduction in the composite outcome of cardiovascular death or worsening heart failure.
• For every 21 patients treated with Farxiga, one cardiovascular death, heart failure hospitalization, or urgent heart failure visit was avoided during the trial.
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