Drug and biotech companies will face an emerging trend of outside interference on pending drug reviews at FDA. The events surrounding the final outcome of FDA's review of Bristol-Myers Squibb and Merck's diabetes drug muraglitazar (Pargluva) signal that outside medical centers and prominent researchers will voluntarily play a larger role in drug safety oversight in the future.
By Ramsey Baghdadi
It was so close. FDA had finished its review of Bristol-Myers Squibb Co. /Merck & Co. Inc. ’s type 2...
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The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
