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Incheon, South Korea: Researchers review single-vesicle tools for earlier cancer diagnosis and personalized medicine
- Researchers at Incheon National University and the University of Pennsylvania reviewed technologies for analyzing extracellular vesicles individually to overcome limitations of bulk testing methods.
- The study highlights potential for detecting rare disease-linked vesicles with high precision for earlier diagnosis of pancreatic cancer, cholangiocarcinoma, and lung adenocarcinoma.
- Advanced methods combining microfluidics, sequencing, and signal amplification could enable routine liquid biopsies for monitoring cardiovascular and neurodegenerative disorders.
- Future developments may integrate artificial intelligence to interpret vast datasets from platforms analyzing up to one million vesicles per test.
- The review suggests single-EV profiling could move from specialized laboratories into mainstream healthcare within the next decade for personalized treatment decisions.
Sanofi secures EU recommendation for tolebrutinib in multiple sclerosis
Sanofi received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for tolebrutinib, a treatment for secondary progressive multiple sclerosis. The drug showed a 31 per cent reduction in disability progression and a 38 per cent decrease in new brain lesions compared with placebo. This decision follows a rejection by US regulators in December due to safety and efficacy concerns. If approved, the drug will be marketed in Europe as Cenrifki.
Insilico Medicine receives IND clearance for rentosertib inhalation study
Insilico Medicine announced that the inhalation formulation of Rentosertib (ISM001-055) has received investigational new drug clearance from China's Center for Drug Evaluation. This approval enables a direct-to-lung Phase 1 clinical study involving healthy volunteers and patients with idiopathic pulmonary fibrosis. The trial aims to evaluate the TNIK inhibitor's safety and efficacy via inhalation, targeting faster onset and higher local bioavailability. This marks the 13th program from Insilico's AI-driven pipeline to receive clearance.
Palo Alto, California: Sonire Therapeutics initiates first U.S. clinical trial for HIFU therapy targeting pancreatic cancer
- Sonire Therapeutics launched the SUNRISE-II feasibility trial to evaluate its ultrasound-guided High-Intensity Focused Ultrasound (HIFU) system for pancreatic cancer treatment in the United States.
- The trial, led by principal investigator Pejman Ghanouni at Stanford Medicine, assesses the safety and feasibility of a minimally invasive, anesthesia-free ablation approach.
- This development follows the first patient treatment in March 2026 and aims to generate clinical evidence to support future regulatory submissions and global commercialization.
- The therapy targets pancreatic cancer, which has a five-year survival rate of approximately 13 percent, offering a potential alternative to current limited treatment options.
- The study is registered on ClinicalTrials.gov under identifier NCT07033689.
Eli Lilly reports Q1 2026 revenue of $19.8 billion and raises full-year guidance
Eli Lilly reported Q1 2026 revenue of $19.8 billion, a 56% increase, beating analyst estimates. Non-GAAP EPS reached $8.26, a 170% year-over-year rise. The company raised its full-year 2026 revenue guidance to $82-85 billion and EPS to $35.50-$37.00. Eli Lilly now holds over 60% of the US GLP-1 prescription market. The firm also announced the launch of Foundayo, an oral GLP-1 candidate, and continues investing in manufacturing and pipeline development including retatrutide.
Africa CDC warns of cross-border spread of mpox and cholera
The Africa Centres for Disease Control and Prevention (Africa CDC) has raised alarms regarding the cross-border transmission of mpox and cholera across the continent. Dr Wazih N. Cho, an intelligence analyst at Africa CDC, noted that mpox hotspots are shifting, with Madagascar remaining the primary hotspot while cases appear in Mauritius. Although overall cholera cases have declined, the case fatality rate remains at 2.2 per cent, driven largely by the Democratic Republic of Congo and Mozambique. The agency attributes these challenges to weak cross-border monitoring and poor water, sanitation, and hygiene conditions, calling for strengthened regional coordination and infrastructure investment.
Pharma companies prepare IP strategies for anticipated M&A surge amid patent cliff
As major pharmaceutical drugs like Keytruda and Eliquis approach patent expiration between 2026 and 2028, industry leaders including Merck, Pfizer, and Johnson & Johnson are expected to increase M&A activity to restock pipelines. Experts from Withers & Rogers advise biotech firms to ensure intellectual property readiness, including organised portfolios and lifecycle management, to attract investors and facilitate potential acquisitions or joint ventures in the coming years.
AstraZeneca resumes large-scale UK investment following policy shift
AstraZeneca announced a £300 million investment to resume large-scale activity in the UK, expanding sites in Cambridge and Macclesfield. This decision follows a previous withdrawal and aligns with a £150 million investment by Boehringer Ingelheim. The move is attributed to the UK-US pharmaceutical arrangement announced in December, which increased the NICE baseline cost-effectiveness threshold. Richard Torbett of the ABPI stated this signals the restoration of the UK as a global destination for life sciences investment, with 13 commitments totaling £1.575 billion since December.
Henlius and Organon secure European Commission approval for pertuzumab biosimilar
Henlius and Organon have obtained European Commission approval for a pertuzumab biosimilar, expanding access to HER2-targeted therapies for breast cancer patients across Europe. The approval is expected to improve affordability and accessibility while maintaining comparable safety and efficacy to the reference biologic. Additionally, Pfizer reported positive Phase 3 data for its multiple myeloma treatment Elrexfio, showing improved progression-free survival. Genexine also shared promising preclinical data on GX-BP1, a novel candidate targeting the SOX2 transcription factor.
Oruka Therapeutics long-acting psoriasis candidate shows early promise
Mid-stage data from Oruka Therapeutics suggest its investigational candidate ORKA-001 may achieve high skin clearance rates in plaque psoriasis patients, with potential for once-yearly dosing. While 63% of patients in the study reported complete clearance, the findings are considered preliminary due to limited study details, undefined safety profiles, and lack of long-term follow-up data. The article highlights the need for further disclosure and late-stage trials to confirm efficacy and safety before comparing the candidate to existing biologics.
Genexine unveils preclinical data for GX-BP1 targeting SOX2
Genexine, Inc. presented preclinical data for GX-BP1, a novel bioPROTAC designed to degrade the transcription factor SOX2, at the American Association for Cancer Research Annual Meeting 2026. The compound demonstrated approximately 70% tumor growth inhibition as a monotherapy and achieved 87%–96% inhibition in combination with chemotherapy agents. GX-BP1 successfully reversed resistance mechanisms in osimertinib-resistant models and eliminated cancer stem cell populations. The company plans to proceed with investigational new drug-enabling studies and is seeking global licensing partnerships.
Boehringer Ingelheim survodutide meets primary endpoints in phase III obesity trial
Boehringer Ingelheim's investigational dual glucagon/GLP-1 receptor agonist survodutide met primary endpoints in the Phase III SYNCHRONIZE-1 study. Adults with obesity or overweight without type 2 diabetes achieved up to 16.6% average body weight reduction after 76 weeks, compared with 3.2% in the placebo group. Additionally, 85.1% of treated participants lost at least 5% of body weight versus 38.8% in the placebo arm. The therapy demonstrated significant reductions in fat mass and waist circumference. Safety was consistent with GLP-1 class profiles, with gastrointestinal adverse events being the most common. Full results are expected at the American Diabetes Association's 2026 Scientific Sessions.
Zealand Pharma and Roche advance petrelintide to Phase 3 for chronic weight management
Zealand Pharma and Roche announced plans to advance petrelintide, a long-acting amylin analog, into Phase 3 clinical trials for chronic weight management, with initiation expected in the second half of 2026. The decision follows internal program endorsement based on encouraging Phase 2 data from the ZUPREME-1 trial, which showed up to 10.7% mean weight loss at 42 weeks. The collaboration, entered into in March 2025, includes an upfront payment of $1.65 billion and potential milestones up to $5.3 billion. The Phase 3 program will evaluate efficacy, safety, and tolerability of once-weekly subcutaneous dosing in patients with overweight or obesity.
FDA grants priority review to tislelizumab and zanidatamab combination for HER2-positive GEA
The US Food and Drug Administration has granted priority review to a supplemental biologics license application from BeOne Medicines for tislelizumab (Tevimbra) combined with zanidatamab (Ziihera) and chemotherapy. The regimen targets first-line treatment for HER2-positive gastroesophageal adenocarcinoma. Phase 3 data from the HERIZON-GEA-01 trial indicate a median overall survival of 26.4 months for the combination arm versus 19.2 months for the control group. The application includes breakthrough therapy designation and plans to utilise Project Orbis for global regulatory review.
Zealand Pharma and Roche advance petrelintide to phase 3 trials; FDA grants priority review for HER2 treatment; Novartis expands US manufacturing
Zealand Pharma and Roche are advancing petrelintide, an amylin analog, into phase 3 trials for chronic weight management, with studies expected to begin in the second half of 2026. The FDA granted priority review to a HER2-targeted treatment strategy for gastroesophageal adenocarcinoma, supported by phase 3 data showing improved survival outcomes. Novartis finalized the addition of a seventh US manufacturing facility as part of a broader investment strategy to increase domestic production capacity. These developments highlight industry progress in metabolic disease, oncology, and manufacturing infrastructure.
Biomanufacturing evolves with smarter single-use tech and resilient supply chains
INTERPHEX 2026 panel discussions highlighted the evolution of biomanufacturing, focusing on smarter single-use technologies and supply chain resilience. Experts from Thermo Fisher Scientific and Sartorius noted challenges in scaling single-use systems for long-duration commercial manufacturing. Meanwhile, industry leaders are adopting distributed manufacturing and on-demand production to address supply chain weaknesses exposed by the pandemic, aiming to reduce risk and cost while maintaining quality standards.
Pfizer Elrexfio improves progression-free survival in phase 3 myeloma trial
Pfizer announced positive topline results from the Phase 3 MagnetisMM-5 trial evaluating elranatamab (Elrexfio) in patients with relapsed or refractory multiple myeloma. The study met its primary endpoint at interim analysis, demonstrating a statistically significant improvement in progression-free survival compared with standard-of-care therapy. The findings suggest Elrexfio may offer a competitive option in earlier lines of therapy. The trial is ongoing with overall survival as a key secondary endpoint.
Amgen reports 4% product sales growth in Q1 2026 amid patent challenges
Amgen Inc reported a 4% increase in product sales for the first quarter of 2026, driven by a 24% year-over-year growth in its six key drivers including Repatha, Evenity, and Tezspire, which generated $5.6 billion. The company highlighted progress in its R&D pipeline and AI integration. However, the report noted anticipated sales erosion for Prolia and Xgeva due to biosimilar competition and ongoing tax litigation with the IRS. Additionally, enrollment in a Blinatumomab trial was paused due to inflammatory reactions. CEO Robert Bradway confirmed continued activity in business development and M&A.
Pacira BioSciences reports strong Q1 2026 results driven by product growth
Pacira BioSciences Inc reported strong first-quarter 2026 results, with its 5x30 strategy delivering intended business outcomes. Flagship product EXPAREL showed renewed growth, while ZILRETTA and iovera sales increased by 15% and 21% year-over-year respectively. Despite temporary impacts from winter storms on shipping and surgery schedules, the company highlighted advancements in its clinical pipeline and strong partnerships with Johnson & Johnson MedTech and LG Chem. Non-GAAP gross margin decreased slightly to 80%, and R&D expenses rose due to Phase 2 study advancements.
Syndax Pharmaceuticals reports record Q1 2026 revenue growth driven by Revuforj and Niktimvo sales
Syndax Pharmaceuticals Inc reported combined net revenue exceeding $100 million for Revuforj and Niktimvo in Q1 2026. Revuforj saw double-digit growth due to new NPM-1 patients and adoption, while Niktimvo generated $55 million. The company holds $352.1 million in cash. Challenges include patient attrition due to transplant procedures and competition in the menin inhibitor market. Management expects maintenance therapy restarts to drive future growth.