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FDA claims trial ‘manipulation’ tainted approval of ChemoCentryx drug

FDA claims trial ‘manipulation’ tainted approval of ChemoCentryx drug

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The FDA accused ChemoCentryx of manipulating the results of a pivotal clinical trial used to approve the drug Tavneos, escalating the agency’s effort to pull the treatment from the market.

“New information shows that the …​ ​Read More

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STAT+: Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field

ROME — When Tim Hunt, who leads an organization for cell and gene therapy makers, reached for some reasons for optimism for the jittery field at a conference here last week, he highlighted the recent approvals of rare disease treatments from the likes of Rocket Pharmaceuticals and Regeneron Pharmaceuticals.

There was one other headline he touted as potentially promising: “FDA vaccine chief to leave the agency again.”

The allusion to Vinay Prasad — the Food and Drug Administration’s top regulator of gene and cell therapies as well as vaccines until his departure from the agency last week — was an indication that even at this event, designed to emphasize the opportunities and roadblocks the sector faces in Europe, it couldn’t escape the decisions that are coming from 4,500 miles away.

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ROME — When Tim Hunt, who leads an organization for cell and gene therapy makers, reached for some reasons for optimism for the jittery field at a conference here last week, he highlighted the recent approvals of rare disease treatments from the likes of Rocket Pharmaceuticals and Regeneron Pharmaceuticals.

There was one other headline he touted as potentially promising: “FDA vaccine chief to leave the agency again.”

The allusion to Vinay Prasad — the Food and Drug Administration’s top regulator of gene and cell therapies as well as vaccines until his departure from the agency last week — was an indication that even at this event, designed to emphasize the opportunities and roadblocks the sector faces in Europe, it couldn’t escape the decisions that are coming from 4,500 miles away.

Continue to STAT+ to read the full story…

Read More

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Founders face pressure from all sides as biotech crawls toward recovery

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In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.

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J&J’s Ottava surgical robot meets primary endpoints in gastric bypass study

Johnson & Johnson MedTech is touting positive results from the first clinical study of its Ottava soft-tissue surgical robot, showing the system can safely perform gastric bypass surgery.​Read More

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Johnson & Johnson MedTech is touting positive results from the first clinical study of its Ottava soft-tissue surgical robot, showing the system can safely perform gastric bypass surgery.​Read More

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