FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations
The company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
The licensed intellectual property covers methods and designs for CAR constructs engineered to function in myeloid cell populations
Strong performances in its Life Science, Healthcare and Electronics divisions — particularly Process Solutions, Cardiovascular treatments and Semiconductor Materials — powered the company’s results
The trial met its primary endpoint, showing statistically significant improvements in Myasthenia Impairment Index (MGII) Patient-Reported Outcome (PRO) ocular scores at Week 4
It is also approved for?AIDS-related Kaposi sarcoma?after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma
The funding will be spread over four years, with BXLS also eligible for regulatory and commercial milestones, plus royalties on worldwide sales
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