Pharmaceutical News
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Lilly’s Taltz-Zepbound combination delivers psoriasis and psoriatic arthritis benefits one year
Eli Lilly’s TOGETHER-PsO and TOGETHER-PsA trials evaluated Taltz with Zepbound for adults with psoriatic disease and obesity. Results showed significant improvements in disease activity and metabolic outcomes at Week 52, with a notable safety profile. The combination treatment effectively addressed psoriatic disease and obesity concurrently. Read more
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GSK advances mRNA seasonal flu vaccine to Phase III after positive Phase II data
GSK is moving its investigational mRNA influenza vaccine candidate to Phase III after promising Phase II results, which indicated better immune responses than existing vaccines. The vaccine targets both haemagglutinin and neuraminidase, aiming to enhance protection. The Phase III trial is set to begin in September 2026, pending regulatory approval. Read more
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Simcere Zaiming licenses SIM0660 to Roche in $1.53B deal for global development
Simcere Zaiming has signed an exclusive global licensing deal with Roche for the development of SIM0660, a tri-specific antibody targeting CD79a, CD19, and CD3, aimed at B-cell-mediated diseases. The deal is worth up to $1.530 billion. Roche will handle development and commercialization, enhancing the therapy’s clinical potential. Read more
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Enhertu plus pertuzumab gains EU approval, cuts progression risk 44% breast cancer
AstraZeneca and Daiichi Sankyo’s Enhertu, combined with pertuzumab, has been approved in the EU for first-line treatment of unresectable or metastatic HER2-positive breast cancer. Based on the DESTINY-Breast09 trial, the combination showed a 44% reduction in disease progression risk, with median progression-free survival of 40.7 months, marking a significant advancement in treatment options. Read more
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AstraZeneca completes Zegfrovy deal as FDA breakthrough advances lung cancer treatment globally
AstraZeneca has finalized a global license agreement with Dizal Pharmaceuticals for Zegfrovy, an EGFR inhibitor for lung cancer. Already approved in the US and China for second-line treatment, AstraZeneca plans to seek first-line approval following positive trial results. The deal involves $600 million upfront and potential future payments of $900 million. Read more
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AstraZeneca’s Tagrisso–Orpathys Scores Major Phase III Win in EGFR-Mutated Lung Cancer
AstraZeneca’s Tagrisso combined with Orpathys showed significant improvement in progression-free survival for untreated patients with advanced EGFR-mutated non-small cell lung cancer exhibiting MET overexpression, as per the Phase III SANOVO trial results. The combination targets both EGFR and MET pathways, potentially enhancing treatment efficacy compared to Tagrisso alone. Read more
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Novartis’ Remibrutinib Scores Phase III Win With Significant Relapse Reduction in Multiple Sclerosis
Novartis has reported positive results from Phase III trials REMODEL-1 and REMODEL-2, demonstrating that remibrutinib significantly reduces the annualized relapse rate in adults with relapsing multiple sclerosis compared to teriflunomide. Remibrutinib also showed superiority in all key secondary endpoints and maintained a favorable safety profile. Regulatory approval is planned. Read more
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Turkish Competition Authority Launches Investigation Into Teva Over Generic Competition
The Turkish Competition Authority has initiated an investigation into Teva Pharmaceuticals to evaluate potential anti-competitive practices that may hinder the entry of generic medicines. The focus is on divisional patent applications and related withdrawal practices, assessing compliance with Article 6 of Act No. 4054 on competition protection. Read more
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FDA Authorizes Abbott’s First Wearable Device to Continuously Monitor Ketone Levels and Blood Sugar
The FDA has authorized Abbott Diabetes Care’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged 2 and older with diabetes. This device is the first in the U.S. to monitor ketones and glucose continuously, providing real-time data to help prevent diabetic ketoacidosis. Read more
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Insmed’s BRINSUPRI Approved in Japan for Non-Cystic Fibrosis Bronchiectasis
Insmed’s BRINSUPRI (brensocatib) has received approval from Japan’s Ministry of Health for treating non-cystic fibrosis bronchiectasis in patients aged 12 and older. This marks it as the first approved treatment in Japan. The approval follows positive Phase 3 ASPEN study results, showcasing efficacy in reducing exacerbations and lung function decline. Read more
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Lilly Expands Access to Obesity Medicines Through Medicare GLP-1 Bridge Program
Eli Lilly is launching the Medicare GLP-1 Bridge program, allowing eligible Medicare Part D beneficiaries to access obesity medications for $50 monthly. This initiative aims to enhance treatment affordability and access while positioning obesity as a chronic health issue. Eligibility requires prior authorization, and access is not guaranteed. Read more
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Fosun Pharma’s FXR0906 Enters Phase 1 Clinical Trial in China for Hypertriglyceridemia
Fosun Pharma’s FXR0906, a liver-targeted siRNA therapy for hypertriglyceridemia, has begun clinical development in China with the first participant dosed in a Phase 1 trial. This therapy aims to lower serum triglyceride levels by silencing APOC3 mRNA, representing a potential new treatment option for the approximately 10 million patients suffering from severe hypertriglyceridemia in China. Read more