• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    High Drug Loading Amorphous Solid Dispersions

    Parenteral Drug Delivery Trends

    Selecting the Right Outsourcing Model for Emerging Biotech

    Inhaled Drug Delivery Technology

    The Future of Biologics: Accelerating Production, Reducing Costs
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Spark Therapeutics Appoints CTO

    Cryoport Launches ESG Program

    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail

    Thermo Fisher Scientific Completes Mesa Biotech Acquisition

    Ashfield Engage, Popit Form Digital Monitoring Collaboration
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Solid Dose Market Trends

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    C2 Pharma Completes Multiple Regulatory Filings

    Bormioli Opens New Glass Research Center
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing

    PwC Joins Medicines Manufacturing Innovation Centre
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Ashfield Engage, Popit Form Digital Monitoring Collaboration

    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    CrownBio & JSR Life Sciences Partner with Cambridge Quantum Computing
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    PCI Pharma Services

    test company saurabh

    Reed-Lane

    Almac Group

    Syngene
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Emergent BioSolutions

    Aphena Pharma Solutions

    Reed-Lane

    test company saurabh

    Alcami
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    Diamond Pharma Services Supports GenSight Biologics

    Provides EU regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ.

    Diamond Pharma Services Supports GenSight Biologics
    Related CONTENT
    • Solid Dose Market Trends
    • AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    • Vetter continues its successful performance at the 2021 CMO Leadership Awards
    • FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site
    • Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine
    Contract Pharma Staff10.05.20
    Diamond Pharma Services, a technical services and regulatory affairs consulting group, provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight Biologics, including the preparation, authoring support, agency communication and submission of GenSight’s first Marketing Authorization Application to the European Medicines Agency (EMA), for its novel ocular gene therapy LUMEVOQ. The EMA decision is expected in the second half of 2021.
     
    LUMEVOQ (Lenadogene nolparvovec) is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary Optic Neuropathy (LHON) caused by mutation in the ND4 mitochondrial gene. LHON mainly affects young males, and the ND4 mutation results in the worst visual outcomes, with most patients becoming legally blind. There is a high unmet medical need for LHON patients, of which there are 800-1200 in the EU and the U.S. annually.
     
    Headquartered in Paris, France, GenSight is a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. Diamond has provided GenSight with regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ leading up to the MAA assessment. 
     
    “We are pleased GenSight Biologics chose to work with our team of experts at Diamond to provide European Regulatory, Pharmacovigilance, Quality and Compliance support for LUMEVOQ, its first MAA submission, and the first for a gene therapy treating a mitochondrial disease. It has been a personal ambition of mine to have the opportunity to work on a gene therapy within the ophthalmic arena, and GenSight has allowed Diamond that opportunity and that privilege,” said Maureen Graham, managing director, regulatory, Diamond Pharma Services. "This submission adds to Diamond’s broad experience in providing support to companies developing advanced therapy medicinal products (ATMPs), which includes over 50 programs at various stages of development, and two MAA approvals - Glybera and Yescarta.”
    Related Searches
    • Drug Development
    Suggested For You
    Solid Dose Market Trends Solid Dose Market Trends
    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    Vetter continues its successful performance at the 2021 CMO Leadership Awards Vetter continues its successful performance at the 2021 CMO Leadership Awards
    FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site
    Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine
    FDA Approves BMS CAR-T Cell Therapy FDA Approves BMS CAR-T Cell Therapy
    Anova Enterprises Acquires Corlexia Clinical Services Anova Enterprises Acquires Corlexia Clinical Services
    Thermo Fisher, JW Therapeutics Form CAR-T Partnership in China Thermo Fisher, JW Therapeutics Form CAR-T Partnership in China
    Catalent, Trizell Enter Cell Therapy Deal Catalent, Trizell Enter Cell Therapy Deal
    Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement
    UK Secures 40M Doses of Valneva COVID-19 Vax UK Secures 40M Doses of Valneva COVID-19 Vax
    Recipharm, Medspray Launch Resyca JV Recipharm, Medspray Launch Resyca JV
    Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership
    Delivering Custom Client Solutions Delivering Custom Client Solutions
    20th Annual Contracting & Outsourcing Conference & Exhibition 20th Annual Contracting & Outsourcing Conference & Exhibition

    Related Breaking News

    • Breaking News | Collaborations & Alliances | Drug Development | Industry News | Solid Dosage/Creams/Ointments
      Pfizer Partners with Medicines Manufacturing Innovation Center

      Pfizer Partners with Medicines Manufacturing Innovation Center

      To transform the formulation of oral solid dosage medicines.
      Tim Wright, Editor, Contract Pharma 02.25.21

    • Breaking News | Drug Development | Industry News
      Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement

      Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement

      Sentynl acquires CUTX-101 Copper Histidinate for the treatment of Menkes disease for $20 million in upfront and regulatory milestones.
      Kristin Brooks 02.24.21

    • Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News | Information Technology
      Pfizer Selects Seven Bridges to Support RNA Sequencing Data

      Pfizer Selects Seven Bridges to Support RNA Sequencing Data

      Seven Bridges will centralize and manage terabytes scRNASeq data, which provides detailed analysis of gene expression in individual cells.
      Kristin Brooks 02.24.21


    • Breaking News | Drug Development | Promotions & Moves
      Aevitas Therapeutics Appoints President and CEO

      Aevitas Therapeutics Appoints President and CEO

      Dr. Markus Peters offers a 25-year track record of developing and commercializing orphan and specialty pharmaceuticals.
      Charles Sternberg, Assistant Editor 02.22.21

    • Breaking News | Collaborations & Alliances | Drug Development
      Lilly, Rigel Enter Exclusive CNS Development Collaboration

      Lilly, Rigel Enter Exclusive CNS Development Collaboration

      Lilly will pay $125 million upfront and up to $835 million in potential milestones for Rigel's lead RIPK1 inhibitor, R552.
      Kristin Brooks 02.18.21

    • Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
      Biomunex, Onward Ink Strategic Antibody Development Pact

      Biomunex, Onward Ink Strategic Antibody Development Pact

      Exclusive worldwide license and development agreement will leverage Biomunex' next gen bi- and multi-specific antibody platform in hematological malignancies.
      Kristin Brooks 02.16.21


    • APIs | Breaking News | Drug Development | Formulation Development | Industry News | Solid Dosage/Creams/Ointments
      Lonza Expands Solid Small Molecule Services

      Lonza Expands Solid Small Molecule Services

      To encompass all aspects of solid form screening and characterization of small molecule APIs.
      Kristin Brooks 02.16.21

    • Biologics, Proteins, Vaccines | Collaborations & Alliances | Drug Development
      Molecular Templates, BMS Enter Strategic Research Pact

      Molecular Templates, BMS Enter Strategic Research Pact

      Aims to discover and develop multiple therapies for specific oncology targets utilizing MTEM’s next-gen engineered toxin body (ETB) platform.
      Kristin Brooks 02.11.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Industry News
      AbbVie, Caribou Ink CAR-T Collaboration

      AbbVie, Caribou Ink CAR-T Collaboration

      Leverages Caribou's next-generation CRISPR genome editing technology platform and AbbVie's antigen-specific binders.
      Tim Wright, Editor, Contract Pharma 02.10.21


    • Breaking News | Drug Development | Industry News | Laboratory Testing
      Quotient Sciences Acquires Arcinova

      Quotient Sciences Acquires Arcinova

      Acquisition expands Quotient’s services with drug substance, drug product and clinical testing capabilities.
      Kristin Brooks 02.09.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
      Paragon Biosciences Expands Cell and Gene Therapy Platform

      Paragon Biosciences Expands Cell and Gene Therapy Platform

      Launches CiRC Biosciences with an initial focus on developing eye disease treatments.
      Tim Wright, Editor, Contract Pharma 02.08.21

    • Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
      J&J Submits EUA for Single-Shot Janssen COVID Vax Candidate

      J&J Submits EUA for Single-Shot Janssen COVID Vax Candidate

      Plans to distribute vaccine to U.S. government immediately following authorization, and expects to supply 100 million doses in 1H21.
      Kristin Brooks 02.05.21


    • Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
      Vaxart Oral COVID-19 Vax Tablet Shows Promise

      Vaxart Oral COVID-19 Vax Tablet Shows Promise

      Phase I study reached primary and secondary endpoints of safety and immunogenicity.
      Kristin Brooks 02.03.21

    • Breaking News | Clinical Trials | Drug Development | Industry News
      Affimed, Roche Explore AFM24, Tecentriq Combo

      Affimed, Roche Explore AFM24, Tecentriq Combo

      To investigate the combination for the treatment of advanced solid epidermal growth factor receptor (EGFR) expressing malignancies.
      Kristin Brooks 02.03.21

    • Breaking News | Collaborations & Alliances | Drug Development
      Imcyse, Pfizer Enter Autoimmune Research Alliance

      Imcyse, Pfizer Enter Autoimmune Research Alliance

      Will develop Imotope candidates to potentially treat Rheumatoid Arthritis.
      Charles Sternberg, Assistant Editor 02.03.21

    Trending
    • Catalent Acquires Delphi Genetics
    • Inside A Vaccine Trial
    • Pfizer Selects Seven Bridges To Support RNA Sequencing Data
    • Pfizer Partners With Medicines Manufacturing Innovation Center
    • ICON Acquires Medpass
    Breaking News
    • Spark Therapeutics Appoints CTO
    • Cryoport Launches ESG Program
    • U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    • Thermo Fisher Scientific Completes Mesa Biotech Acquisition
    • Ashfield Engage, Popit Form Digital Monitoring Collaboration
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • High Drug Loading Amorphous Solid Dispersions
    • Parenteral Drug Delivery Trends
    • Selecting the Right Outsourcing Model for Emerging Biotech
    • Inhaled Drug Delivery Technology
    • The Future of Biologics: Accelerating Production, Reducing Costs
    • Business Intelligence For (and From) the Lab
    • Communicating Your Contracting Priorities to Your Drug Company Customers
    • COVID-19 Impact Report
    • The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    ACI Urges Senate to Approve Regan as EPA Administrator
    Estée Lauder Signs Actress Ana de Armas
    GUM Recalls Oral Spray
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login