Friday, November 22, 2019

CAR T-Cell Therapies: Current Limitations & Future Opportunities

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CAR-T therapies have been a hot area right now. Pharmaceutical companies and biotechnology companies are all trying to jump into the CAR-T ...
Sunday, November 17, 2019

Dilemma in Withdrawing a Drug Approved Through Accelerated Approval Pathway

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Last week, NPR reported that premature birth medication Makena did not work and debate was on whether the Makena should be pulled from the m...
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Monday, November 11, 2019

Breakthrough or Political Pressure: GV-971 and aducanumab for treatment of Alzheimer's Disease

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Recently, we saw the breakthroughs in drug development for Alzheimer disease. The Chinese regulatory authority (NMPA) approved GV-971 (Oli...
1 comment:
Monday, October 14, 2019

A clinical trial with sample size = 1?

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In the October issue of New England Journal of Medicine, Kim and Hu et al from Boston Children's Hospital published a paper " Patie...
Sunday, October 13, 2019

Real-World Evidence for Regulatory Decision Making - Some Updates

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This year, real-world data and real-world evidence is the theme in every conference in the clinical trial and drug development area. Just a ...
1 comment:
Sunday, September 08, 2019

Cox proportional hazards regression model: univariate, multivariate, adjusted, stratified

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Cox proportional hazards regression model has been called different names (Cox model, Cox regression model , Proportional hazards model, ......
2 comments: