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Teva Stumbles, Actelion Rises In MS: Clinical Protocols Lost And Gained

 
• By Bridget Silverman

FDA casts a vote of confidence in Actelion's Phase III trial design for its oral multiple sclerosis candidate ponesimod, while Teva loses its special protocol assessment for laquinimod after dosing changes. Plus more regulatory clinical trial news in brief.

Recent announcements by Actelion Pharmaceuticals Ltd., Athersys Inc., and Tracon Pharmaceuticals Inc. – and a cautionary example from Teva Pharmaceutical Industries Ltd. and Active Biotech AB – highlight the influential role regulators play in the design of clinical trials.

An FDA clinical hold placed on Alcobra Ltd.'s lead product also spotlights the power of the agency's safety oversight...

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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.

More from R&D

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.