1. Pink Sheet

Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption

 
• By Bridget Silverman

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.

"Uncertainty Ahead” sign on a background of blue sky with clouds

The US FDA’s Center for Drug Evaluation and Research is coming off what in many lights could be the best year ever for new drugs – a record number of novel agents, reviewed in record low times, reflecting high levels of innovation and addressing many previously unmet needs – but the early weeks of 2019 suggest the beginning of different story, marked by resurgent safety concerns and the disruption of the regulatory system posed by the recent partial government shutdown.

Despite these headwinds, however, the pipeline of novel candidates for approval looks strong in the new year. The Pink Sheet’s...

More from Product Reviews

More from Pink Sheet

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.