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Clovis Withdraws Rubraca’s Original Ovarian Cancer Indication Shows FDA Emphasis On Survival Data

 
• By Bridget Silverman

Clovis’ argument that an overall survival advantage seen for the chemotherapy control arm in the ARIEL4 trial is an artifact of the crossover design does not keep third-line and later ovarian cancer use on label; sNDA for first-line maintenance delayed.

'Withdrawal' hand written note laying on pile of folders and documents

Clovis Oncology highlighted the US FDA’s “increasing emphasis on overall survival (OS) in oncology trials” as a driving force behind the company’s voluntary withdrawal of one of the indications for the PARP inhibitor Rubraca (rucaparib) effective 10 June 2022.

The withdrawn claim, for treatment of ovarian and related cancers with deleterious BRCA mutations after two or more lines of...

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Generic Drug Office’s Policy Staff Returning To US FDA

 
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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

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

 
• By Eliza Slawther

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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.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

More from Pathways & Standards

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

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.