Pharmaceutical News
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Boehringer Launches Three Phase 3 Trials in Hard-to-Treat Cancers
Boehringer Ingelheim has launched three Phase 3 trials focusing on precision oncology for aggressive cancers with high unmet needs, evaluating the investigational therapies obrixtamig and zongertinib. These studies target small cell lung cancer, extrapulmonary neuroendocrine carcinoma, and HER2-mutant non-small cell lung cancer, aiming to enhance treatment strategies and patient outcomes. Read more
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FDA Grants Priority Review to Alexion’s Ultomiris for Immunoglobulin A Nephropathy
The FDA has granted Priority Review to Alexion’s Ultomiris for treating adults with immunoglobulin A nephropathy. Supported by promising results from the I CAN trial, Ultomiris significantly reduced proteinuria, showing a 46.6% decrease compared to 5.6% for placebo. A decision on approval is expected in Q4 2026. Read more
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Merck Appoints Miguel Fernández Alcalde as Global Strategy Head, Monia Vial as EMD Serono President
Merck has appointed Miguel Fernández Alcalde as Head of Global Commercial Strategy and Monia Vial as President of EMD Serono and Head of North America. These changes aim to enhance Merck’s commercial leadership and support its healthcare transformation and global growth strategy, focusing on portfolio expansion and pipeline impact. Read more
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FDA Approves Ionis’ Tryngolza to Reduce Acute Pancreatitis Risk
The FDA has approved Ionis Pharmaceuticals’ Tryngolza (olezarsen), the first treatment to reduce acute pancreatitis risk in adults with severe hypertriglyceridemia. This once-monthly therapy significantly lowers triglyceride levels and demonstrates a lower pancreatitis rate, addressing a critical medical need. Adverse reactions include injection-site issues and liver enzyme elevation. Read more
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EU Approves Sanofi’s Cenrifki, First Disability-Targeting MS Therapy
The European Commission has approved Sanofi’s Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis without recent relapses, marking it as the first EU medicine aimed at disability progression. Supported by Phase 3 trial results, it addresses a significant need, although liver monitoring is crucial due to safety risks. Read more
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Japan Approves Sanofi’s Wayrilz for Difficult-to-Treat ITP
Japan’s Ministry of Health has approved Sanofi’s Wayrilz (rilzabrutinib) for chronic immune thrombocytopenia (ITP) in patients unresponsive to current treatments. The oral BTK inhibitor shows significant improvements in platelet responses and patient quality of life, as demonstrated in the Phase 3 LUNA 3 trial, offering a new treatment option for ITP patients. Read more
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FDA Expands Dexcom’s Stelo Continuous Glucose Monitor to Kids
The FDA has authorized Dexcom’s Stelo Glucose Biosensor System for over-the-counter use in children aged 2 and older who do not use insulin. This marks the first OTC continuous glucose monitor approved for pediatric use, enhancing access to glucose monitoring for managing diabetes and understanding glucose patterns related to lifestyle. Read more
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Lilly’s Jaypirca Cuts CLL Progression Risk 45% in Phase 3 Trial
Eli Lilly announced that Jaypirca significantly enhances progression-free survival when combined with venetoclax and rituximab in previously treated CLL/SLL patients. The Phase 3 BRUIN CLL-322 study showed a 45% reduced risk of disease progression or death. Safety profiles were comparable, and results will be submitted for regulatory review. Read more
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Japan Approves Sanofi’s Sarclisa SC, Cuts Infusion Reactions 94%
Sanofi’s Sarclisa (isatuximab) receives approval in Japan for subcutaneous treatment of multiple myeloma, following EU authorization. This approval allows its use with standard therapies and may lead to Japan’s first oncology drug given by an on-body injector. The Phase 3 IRAKLIA study shows similar efficacy to intravenous Sarclisa with fewer reactions. Read more
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Sanofi Appoints Xaira’s Paulo Fontoura to Lead Global R&D
Sanofi has appointed Paulo Fontoura as Executive Vice President and Global Head of Research & Development Pharma, effective September 1, 2026. He succeeds Dr. Houman Ashrafian and will oversee the company’s R&D organization, focusing on innovation and pipeline development. Fontoura brings over 25 years of experience, including his roles at Xaira Therapeutics and Roche. Read more
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Roche’s Lunsumio–Polivy Cuts LBCL Progression Risk 59%; FDA Accepts sBLA
Roche announced that the FDA has accepted its sBLA for Lunsumio VELO (mosunetuzumab) combined with Polivy (polatuzumab vedotin) for adults with relapsed or refractory large B-cell lymphoma after prior therapy. The regimen showed significant improvements in progression-free survival and could provide an outpatient chemotherapy-free treatment option, pending approval by February 9, 2027. Read more
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Takeda’s Oveporexton Improves Cognition, Sleep in Phase 3 NT1 Studies
Takeda presented Phase 3 data for oveporexton (TAK-861) at SLEEP 2026, showing significant enhancements in daily functioning, cognitive performance, and nighttime sleep for narcolepsy type 1 patients. The investigational drug aims to address orexin deficiency, with substantial results supporting its potential as a first-in-class therapy, pending FDA approval. Read more