Week of November 11, 2024

Each week we highlight five things affecting the life sciences industry. Here’s the latest.

• Experts at the Outsourcing in Clinical Trials Conference in New England discussed strategies for navigating the challenging biopharma ecosystem, per Clinical Trials Arena.
• Innovative approaches such as artificial intelligence in trial recruitment and partnerships with patient advocacy groups for rare disease research were highlighted as key methods to stabilize operations.

• The U.S. Food and Drug Administration has raised concerns about the effectiveness of phenylephrine, a common ingredient in many over-the-counter decongestants, citing recent studies that question its efficacy.
• CNN reports that this move could lead to significant changes in the availability of popular cold and allergy medications that contain phenylephrine.

• FDA Commissioner Robert Califf emphasized the importance of respecting evidence and expertise in his remarks about the qualities he hopes his successor will have, per Fierce Pharma.
• Califf highlighted the need for an executive who can listen to diverse viewpoints and understand the critical role of high-quality evidence in decision-making.

• The Inflation Reduction Act and BIOSECURE Act are significantly influencing the contract development and manufacturing organization sector in India, per BioProcess International.
• These legislative measures are expected to boost investment and innovation in India’s biomanufacturing capabilities, positioning the country as a competitive player in the global market.

• Experts have welcomed the urgent revision of European medical device regulations, describing it as a positive and timely step to ensure patient safety and device efficacy, reports Med-Tech News.
• The revised regulations aim to address current challenges in the medical device sector, including compliance and market access issues.

For more insights in life sciences, check out RSM’s industry outlook.