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Genentech Thinks Pertuzumab Will Escape Avastin Problem, Despite Similarities

 
• By Emily Hayes

Genentech is confident about a Dec. 6 BLA filing for the monoclonal antibody pertuzumab in HER2 positive metastatic breast cancer with FDA, even though the application is based on a PFS benefit in a single trial.

Genentech Inc.is once again looking for FDA approval for a metastatic breast cancer therapy based on impressive progression-free survival data from a single trial. But the company maintains that the pertuzumab application will not run into the same difficulties as Avastin.

For one thing, the BLA submission is for full approval, not going through the accelerated approval program that led to the agency’s subsequent withdrawal of the breast cancer indication for Avastin (bevacizumab) Also see "Avastin

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

 
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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.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
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FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.