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Pfizer COVID Vaccine Trial Proved Remote Monitoring, Other Innovations Work, ICON CEO Says

 
• By Derrick Gingery

Steve Cutler, head of the CRO that conducted Pfizer’s study, tells the Pink Sheet that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.

electronically connected globe (shutterstock)
Remote monitoring allowed staff in Japan to check site compliance with enrollment and other protocols in the US and Europe. • Source: Shutterstock

The forced social distancing mandated by the coronavirus may have provided the use case for technology-enabled advancement of clinical trial monitoring and other practices that could see widespread adoption after the pandemic – perhaps best exemplified by the study for the first vaccine authorized in the US.

Like many contract research organizations, ICON PLC was forced to adapt to the realities of the pandemic and remain...

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• By Anabel Costa-Ferreira

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The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

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• By Sue Sutter

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US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

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Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 
• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 
• By Michael McCaughan

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 
• By Neena Brizmohun

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.