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Janssen Exec On Speeding Earlier Myeloma Interventions To Market With Key Biomarker

 
• By Eleanor Malone

Having scored a commercial hit with Darzalex in myeloma, Janssen is looking to speed label expansions to the drug to enable it to intercept earlier in the disease. Janssen R&D executive Craig Tendler explained the importance of addressing smoldering myeloma and of recognizing minimal residual disease as a valid surrogate marker in trials.

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Janssen hopes regulators will help speed its plow with new myeloma surrogate endpoint

Since winning FDA approval in fourth-line use to treat multiple myeloma in November 2015, Darzalex (daratumumab) has won approval in the EU and elsewhere, and seen a series of label expansions establishing it as an important single-agent therapy as well as in combination with other treatments. In 2017, worldwide sales totalled $1.24bn.

Janssen Biotech Inc., which licensed the anti-CD38 antibody from Genmab AS of Denmark in 2012, continues to gather evidence aimed at expanding the drug's use still further. In...

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Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.