Richard Pazdur Named Director of CDER by FDA
Appointment Announcement: Richard Pazdur, M.D., has been appointed as the director of the Center for Drug Evaluation and Research by the U.S. Department of Health and Human Services and the FDA.
Experience and Innovations: Dr. Pazdur, a 26-year FDA veteran and founding director of the Oncology Center of Excellence, is recognized for his innovative regulatory approaches that have expedited the development and approval of cancer therapies through various initiatives.
Key Initiatives: He has led projects such as Project Orbis for international oncology product reviews, Project Facilitate for expanded access requests, and Project Renewal for updating prescribing information of older oncology drugs.
Industry Context: The announcement comes amidst ongoing developments in the pharmaceutical industry, with notable companies involved in drug manufacturing and gene therapies listed, including AstraZeneca, Pfizer, and several gene therapy firms.
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- Vaccine Efficacy: A study published in The Lancet Infectious Diseases indicates that infants immunized with Beyfortus experienced an 85.9% reduction in RSV-related lower respiratory tract infection hospitalizations in the first season and a 55.3% reduction in the second season, demonstrating the vaccine's effectiveness and potential for long-term protection.
- Large Study Cohort: Conducted in Galicia, Spain, the study included 11,796 immunized infants with a coverage rate of 94.4%, providing robust data supporting the vaccine's universal applicability and enhancing the effectiveness of public health policies.
- Sustained Impact: The findings reveal that Beyfortus significantly reduced RSV-related hospitalizations and outpatient illness burden during the first season, with a persistent reduction in hospitalizations observed in the second season, underscoring the vaccine's importance in long-term immunity.
- Enhanced Public Health Value: Approved for the prevention of RSV lower respiratory tract disease in infants, Beyfortus is expected to present further data at the RSVVW '26 conference, reinforcing its critical role in global public health and promoting the implementation of universal immunization programs.
- Star-Studded Guest Lineup: The new season of the Impact Podcast features sustainability leaders from renowned brands like Mars, EY, and Prologis, showcasing their daily contributions to making the world a better place, which is expected to draw significant audience interest.
- Innovative Format: The podcast's newly designed user-friendly homepage enhances user experience, allowing listeners easier access to content and further amplifying the show's impact across digital platforms.
- Diverse Topics: Upcoming episodes will include a multi-part conversation with cancer survivor Dr. Dawn Mussallem, sharing her extraordinary journey, aimed at inspiring listeners to reflect on health and the meaning of life.
- Wide Listening Channels: The podcast is available on multiple platforms, including Spotify, Apple Podcasts, and YouTube Music, ensuring a broader audience can access these important sustainability stories.
- Breakthrough Therapy Designation: The FDA has granted Breakthrough Therapy Designation for Rybrevant (amivantamab and hyaluronidase-lpuj) as a monotherapy for adults with advanced head and neck squamous cell carcinoma, applicable to patients with recurrent or metastatic disease after progression on platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, indicating strong recognition and market potential for the new therapy.
- Contract Extension: The collaboration agreement signed by Johnson & Johnson in January 2025 has been extended to mid-2026 under the same economic terms, including a fixed monthly management fee, driven by strong engagement and satisfaction metrics, reflecting ongoing confidence in the program's performance.
- Market Model Development: Trellus Health CEO Marla Dubinsky stated that the company is establishing a scalable go-to-market model for pharmaceuticals, focusing on disciplined execution, recurring revenue growth, and expansion in immunology and inflammation, showcasing a positive outlook for future developments.
- Financial Outlook: Trellus Health expects fiscal 2025 revenue to be approximately $545,000 and has reduced its monthly cash burn to around $400,000, demonstrating improved financial management and confidence in future growth prospects.
- Clinical Trial Results: Ocular Therapeutix reported that 74.1% of patients maintained vision at Week 36 in the SOL-1 Phase 3 trial for Axpaxli, compared to 65.9% in the Eylea group, with a risk difference of 17.5% (p=0.0006); however, the durability advantage fell short of expectations, potentially impacting its commercial outlook.
- Next Steps: The company intends to submit a New Drug Application (NDA) based on the SOL-1 data, and if approved, Axpaxli could become the first tyrosine kinase inhibitor (TKI) commercialized for wet AMD, potentially being the only therapy with a superiority label, which holds significant strategic implications.
- Market Reaction: Ocular Therapeutix shares fell 26.46% in premarket trading, currently priced at $6.62, reflecting market disappointment over the Axpaxli data, despite a 23.33% increase over the past 12 months, indicating a generally positive long-term trend.
- Analyst Ratings: The stock maintains a Buy rating with an average price target of $21.00, with Chardan Capital and Needham keeping their targets unchanged, while HC Wainwright raised its target to $21.00, reflecting analysts' optimistic outlook for the future.
- Leadership Change: Sanofi has announced the appointment of Manuela Buxo as the new Head of Specialty Care, effective March 1, 2026, succeeding Brian Foard, who is leaving the company on February 28, 2026, after successfully launching key medicines like Dupixent globally.
- Experienced Successor: Manuela, currently leading the Global Immunology Alliance Franchise, brings over 20 years of international healthcare experience, particularly in Specialty Care in Europe, and her leadership is expected to further drive the dynamic development of Sanofi's Specialty Care business.
- Commitment to Business Continuity: Sanofi reaffirms its commitment to Specialty Care priorities during this transition, ensuring continuity of execution and maintaining competitive advantages in the market despite leadership changes.
- Positive Executive Remarks: Interim CEO Olivier Charmeil expressed gratitude for Brian's contributions and confidence in Manuela's extensive experience and long-standing commitment to Sanofi, believing she will ensure strong continuity and rapid progress for the business.
- Leadership Transition: Sanofi has announced the appointment of Manuela Buxo as the new Head of Specialty Care, effective March 1, 2026, succeeding Brian Foard, who is leaving after nearly nine years, during which he led the global launch of key medicines like Dupixent.
- Experienced Successor: Manuela, currently leading the Global Immunology Alliance, has driven the global expansion of Dupixent and brings over 20 years of international healthcare experience, particularly in Specialty Care in Europe, which is expected to further enhance the dynamic development of the Specialty Care business.
- Strategic Continuity: Interim CEO Olivier Charmeil emphasized that Manuela's extensive experience and long-standing commitment to Sanofi will ensure business continuity while maintaining growth momentum in Specialty Care, reflecting the company's confidence in future developments.
- Specialty Care Priorities: Sanofi reaffirms its commitment to advancing its Specialty Care priorities and ensuring continuity of execution during this leadership transition to meet market demands and enhance patient care quality.









