FDA Scrutinized Over AstraZeneca Trials: Data Gaps Raise Approval Questions
Summary:
Fresh investigation reveals concerning data irregularities in ticagrelor’s pivotal platelet studies, with missing readings and inaccurate reporting raising questions about the multibillion-pound drug’s approval process and clinical foundation.
Biotech Startups Face Funding Freeze as Public Support Wanes
Summary:
Market volatility and regulatory upheaval continue to dampen biotech investment appetite, with IPO activity grinding to near-standstill as companies struggle with valuation alignment and prolonged capital scarcity affecting both public and private sectors.
Exelixis Scores Major Win Over Bayer in Colorectal Cancer Breakthrough
Summary:
Exelixis’ zanzalintinib combination therapy outperforms existing colorectal cancer treatments in Phase III trials, positioning the company’s third-generation inhibitor as a strategic successor to its current blockbuster franchise.
Rare Disease Experts Question FDA’s Conditional Pathway, Support Overall Direction
Summary:
Leading rare disease experts challenge FDA Commissioner’s proposed conditional approval mechanism, arguing existing regulatory frameworks already provide sufficient flexibility for ultrarare conditions whilst acknowledging creative solutions remain essential.
Open Science vs. IP: How Researchers Can Share and Safeguard Their Work
Summary:
NIH’s forthcoming open access mandate promises accelerated research dissemination but raises concerns about content misuse and author preparedness, as licensing complexities create uncertainty around intellectual property protection and commercial exploitation.
