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Pivotal Trials Are Cheaper For Unmet Needs And Orphan Drugs, JAMA Study Finds

 
• By Bridget Silverman

Analysis of clinical trial costs for CDER’s 2015-2016 novel therapeutic approvals finds pivotal studies are most expensive when a new agent has a similar benefit to already marketed products with well-established clinical profiles. 

Money Wave

The first systemic evaluation of the cost of pivotal clinical trials illustrates the economic logic focusing new drug development on rare diseases and unmet medical needs.

The study, published in JAMA Internal Medicine on Sept. 24, “provides a different perspective to the widely held assumption that...

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More from Clinical Trials

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

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.

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.

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.

More from R&D

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.

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.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.