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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Sanofi to Announce Q4 Earnings on January 29
- Earnings Announcement Date: Sanofi is set to release its Q4 2023 earnings report on January 29 before market open, with analysts expecting a normalized EPS of €1.47 and revenue of €11.12 billion, indicating stability in the company's financial performance.
- Market Expectation Analysis: The analysts' expectations reflect Sanofi's competitiveness in the pharmaceutical industry, particularly against the backdrop of new product launches and growing market demand, which is likely to positively impact the company's stock price.
- Clinical Progress Focus: In its year-end late-stage pipeline review, Sanofi highlighted clinical and regulatory developments, notably the approval of Dupixent for children with asthma in Japan in collaboration with Regeneron, further solidifying its market position in respiratory diseases.
- Investor Conference Participation: Sanofi will present at the 44th Annual J.P. Morgan Healthcare Conference, which is expected to attract investor attention and bolster market confidence in its future growth potential.

Sanofi's Q4 Sales Miss Expectations Despite Growth
- Sales Growth: Sanofi reported Q4 sales of $13.159 billion (11.3 billion euros), a 7% year-over-year increase, yet fell short of the consensus estimate of $13.41 billion, indicating intensified market competition pressures.
- Strong Dupixent Performance: Dupixent sales surged by 32.2% to 4.2 billion euros, driving overall performance, although the company anticipates future sales challenges due to impending patent expirations.
- Vaccine Sales Decline: Vaccine sales decreased by 2.5% to 2 billion euros, primarily due to lower sales of Beyfortus and PPH vaccines, reflecting changing market demand and declining birth rates.
- Future Outlook: Sanofi expects sales to grow at a high single-digit percentage in 2026 and plans to execute a 1 billion euro share buyback program to enhance shareholder returns and market confidence.









