tag accelerated-launch 
Pharmaceutical Technology
SEPTEMBER 30, 2022
Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September. Spark Therapeutics’ Luxturna, indicated for inherited retinal disease (IRD), was the first gene therapy to be approved, in 2017, with a price tag of $850,000 for each eye.
Rethinking Clinical Trials
JULY 22, 2022
ACTIV was stood up in about a month, launching on April 17, 2020, to develop a coordinated research response to speed COVID-19 treatment and vaccine options. The post Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J.
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Rethinking Clinical Trials
MAY 10, 2023
Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. We are looking forward to supporting more.
XTalks
JUNE 28, 2023
Elevidys was granted FDA accelerated approval for the treatment of pediatric patients four to five years of age with DMD who have a confirmed mutation in the DMD gene. million price tag of Elevidys, a one-time gene therapy. Ingram expects the launch to take a few months to pick up due to logistical and policy issues.
pharmaphorum
DECEMBER 17, 2021
Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one. Only a few patients have been getting treated with Aduhelm since launch, with Biogen reporting sales of $1.6
World of DTC Marketing
DECEMBER 13, 2021
As cancer survival rates rise, so do the price tags of life-saving treatments. Few cancer drugs approved via the accelerated FDA approval pathway were judged to have verified benefits based on improvement in survival reported in confirmatory trials. OPENING: American cancer patients spent more than $21 billion on their care in 2019.
pharmaphorum
JANUARY 21, 2022
Medical science is accelerating at a tremendous rate, leading to profound changes in the treatment landscape for many diseases over the last decade. “It This evolution is leading to additional health benefits and health gains, but they are accompanied by major concerns, as very high price tags raise questions about their affordability.”.
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