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Pressure Mounts For Roche On PD-L1 Strategy

 
• By Jessica Merrill

Roche spent much of its first quarter conference call answering questions about its PD-L1 antibody strategy, particularly if the drug might be ready for regulatory filing in 2015, earlier than expected, and how it will compete effectively following on the heels of two competitors.

Investors are increasingly anxious about how Roche’s PD-L1 antibody MPDL3280A will compete effectively as the third in the class of immune checkpoint inhibitors to reach the market, as Bristol-Myers Squibb Co.’s Opdivo (nivolumab) and Merck & Co. Inc.’s Keytruda (pembrolizumab) gain momentum in the melanoma market and progress into lung cancer.

Not surprisingly, management spent most of Roche’s first quarter sales and earnings call April 22 responding to questions from analysts...

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Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
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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

 
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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order.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.

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