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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)

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Collaboration between AbbVie, Biogen and Pfizer creates world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease

The Pharma Data

Managed by the Broad Institute of MIT and Harvard, the browser gives access to results from analyses of whole exome sequencing data from 300,000 UK Biobank research participants. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

Disease 52
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WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

The Pharma Data

Managed by the Broad Institute of MIT and Harvard, the browser gives access to results from analyses of whole exome sequencing data from 300,000 UK Biobank research participants. (Nasdaq: BIIB) and Pfizer (NYSE: PFE). These genetic data have been paired with detailed health information to create this browsable resource. About Biogen.

Disease 52
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Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

executive vice president of Research and Development at Amgen. In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. It’s a commitment that extends beyond introducing novel therapies. Reese , M.D.,

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

Agency IQ

A big legislative question about PAHPA Reauthorization : The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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