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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 7:50 PM EDT | UPDATED JUN 26, 2023 12:41 PM EDT Note: This calendar also include some activities scheduled to take the last week of June, after this piece is published. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

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Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

There’s no science to back any of the allegations up – as demonstrated by the masterful (and even longer) take down of nearly identical substantive allegations in the Zantac ( 2022+4 ) MDL. Takeda Pharmaceutical Co. , Luitpold Pharmaceuticals, Inc. The FDA, for one, advised patients to keep using these drugs. Crockett v.