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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

FDA Law Blog: Drug Discovery

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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Obesity care gets personalised: tailoring therapies with Phenomix

Drug Target Review

Advancing drug development The implications of precision medicine in obesity care extend beyond selecting the right treatment for individual patients; it is also reshaping the development of next-generation obesity drugs. GenturaDxs technology is the basis of Luminexs acclaimed Aries platform.

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Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits

NIH Director's Blog: Drug Development

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. 2012 Jul 6;337(6090):100-104. [4] 5] Clinical development success rates for investigational drugs.

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The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

Conversations in Drug Development Trends

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. The CRISPR technique was first published in 2012, outlining a method to harness the previously underappreciated bacterial immune system. In June 2023, the U.S.

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FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States. This marks another important milestone, after Toripalimab was granted the ODD and the BTD by the FDA.

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Biogen Files New Drug Application for Aducanumab in Japan

The Pharma Data

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. have collaborated on the development and commercialization of aducanumab globally. million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012).

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Athersys Announces Three Appointments to Board of Directors

The Pharma Data

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. drug development initiative from 2012 to February 2019.