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Threshold Presses On In Two Phase III Cancer Trials As Competitors Wilt

 
• By Michael Goodman

Threshold and partner Merck Serono are benefiting from recent high-profile failures in sarcoma and pancreatic cancer. Armed with $100 million in payments since signing with Merck in February 2012, Threshold needs to rise above stiff odds and what some view as equivocal Phase II pancreatic cancer results.

Founded in 2001 as an early specialist in the field of tumor hypoxia, Threshold Pharmaceuticals Inc. finds itself nearing the finish line in two unforgiving indications, soft tissue sarcoma (STS) and pancreatic cancer. With the recent Phase III failure of Ziopharm Oncology Inc.’s palifosfamide in STS, the coast is clear for TH-302 to emerge as a relatively safe front-line alternative to established chemo regimens doxorubicin or ifosfamide.

But the larger pancreatic cancer indication is driving investor interest. Partner Merck Serono SA,the drug division of Darmstadt-based

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Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

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Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By Sue Sutter

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 
• By Anabel Costa-Ferreira

Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.