Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Addressing clinical trials challenges in biopharma ecosystem
- 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.
FDA announces proposal to remove oral phenylephrine from market
- 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 lays out hopes for his successor
- 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.
Inflation Reduction Act matches BIOSECURE in driving CDMO sector in India
- 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 praise revision of European medical device regulations
- 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.