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Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Rethinking Clinical Trials

Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others. It was held virtually on April 28-29, 2021. Learn more.

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New Rare Disease Drugs and Research Advancements

XTalks

Skyclarys (omobaloxone) was approved in 2023 for the treatment of adults and pediatric patients 16 years of age and older with Friedreich’s ataxia, a rare, neurological disease​​. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

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What challenges does the advanced therapies sector face? 

Drug Discovery World

To achieve this, we need greater collaboration between academia, therapy developers and manufacturing equipment developers.” Stella Vnook , CEO, Likarda , notes that a s more regenerative therapy options come to the market, patients will demand access to the treatments, often using the court system. She

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Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

The historic and highly anticipated approval created a flurry of excitement in the Alzheimer’s disease space for patients, healthcare practitioners, advocacy groups and Biogen shareholders alike, as shares of the company jumped more than 50 percent after the announcement. Aducanumab Controversy and Price Tag.

Drugs 98
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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. Both trials are expected to be completed in the second half of 2022.

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Prescription drug prices are out of cotrol

World of DTC Marketing

The pharma industry has been riding a wave of public approval since they developed a vaccine to fight COVID-19, but that goodwill is going to be short lived thanks, in part, to the $56,000 price tag of Biogen’s new drug and insulin that too many people still can’t afford. Even people who are insured have issues.

Drugs 180