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Third-Generation EGFR Inhibitors’ Safety Profiles Under Scrutiny At ASCO

 
• By Emily Hayes and Mary Jo Laffler

In stark contrast with the first generation of EGFR inhibitors, Clovis’ CO-1386 has rash rates that are on par with placebo. But the drug must contend with high rates of excess blood sugar as well as QTc prolongation. AstraZeneca’s AZD9291 has its own safety issues, but coming efficacy results should carry the class.

CHICAGO – The early data on the next generation of epidermal growth factor receptor inhibitors, including drugs from Clovis Oncology Inc., AstraZeneca PLC and Hanmi Pharmaceutical Co. Ltd., suggest significant advances in safety and efficacy over their predecessors in lung cancer, but individual side effect profiles could help differentiate the newcomers.

Results from studies of early stage studies in relapsed/refractory EGFR+ non-small cell lung cancer patients of Clovis’ CO-1686, AstraZeneca’s AZD...

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Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
• By Vibha Sharma

The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 
• By Michael McCaughan

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.