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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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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.

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.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

More from R&D

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.