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Roche Third-Quarter Pipeline Adjustments Include Advancements, Delays

 
• By Shirley Haley

Roche adjusted regulatory expectations for its pipeline during a third-quarter earnings call Oct. 16, moving up filing plans for onartuzumab (MetMAb) in metastatic non-small cell lung cancer to 2014 and pushing back an ocrelizumab filing in multiple sclerosis to 2015, both based on trial enrollment rates.

Roche is accelerating plans to file its novel one-armed antibody onartuzumab (MetMAb/RG3638) in an initial indication of metastatic non-small cell lung cancer by a year thanks to speedy recruitment in the Phase III pivotal trial, Pharmaceuticals Chief Operating Officer Daniel O’Day said Oct. 16 during the firm’s quarterly earnings report, but the Swiss drug giant is also facing delays on other programs.

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EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

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Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
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Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.

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India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

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• By Bridget Silverman

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

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• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.