RP

Ocugen, Inc. Announces U.S. FDA Clearance of IND Amendment to Initiate OCU400 Phase 3 Clinical Trial — First Gene Therapy to Enter Phase 3 with a Broad Retinitis Pigmentosa Indication

Retrieved on: 
Monday, April 8, 2024
Arm, Retinitis pigmentosa, Disease, Patient, Lux, RP, IND, Clutch (eggs), Vaccine, Food, RHO, FDA, BLA, Pharmaceutical industry

“OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.

Key Points: 
  • “OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.
  • Until now, there has been only one marketed product to treat one of the 100 gene mutations associated with RP.
  • In the Phase 1/2 OCU400 clinical trial, a Multi-Luminance Mobility Testing (MLMT) scale was the primary functional endpoint.
  • With the initiation of the Phase 3 clinical trial, OCU400 remains on track for the 2026 BLA approval target.

Ocugen Provides Business Update with Certain Financials for the Year Ending 2023

Retrieved on: 
Tuesday, April 2, 2024
Stargardt disease, Disease, Safety, Webcast, Inflammation, Patient, CGMP, Data, Inhalation, Cohort, RP, Life, Bank statement, Investment, Clinical trial, NIAID, Injection, AMD, Vaccine, Nextgen, Geographic atrophy, RHO, FDA, Lipid metabolism, Government, Oxidative stress, Pharmaceutical industry

Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively

Key Points: 
  • Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively
    MALVERN, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today provided a general business update with certain financials for the year ending 2023.
  • During the fourth quarter of 2023, the Company announced its mucosal vaccine candidate, OCU500, was chosen for the multi-billion-dollar NIAID Project NextGen initiative.
  • The first patient was dosed in the Phase 1/2 trials to assess the safety and efficacy of OCU410ST for Stargardt disease in November 2023.
  • Ocugen’s cash, cash equivalents, and investments totaled $39.5 million as of December 31, 2023, compared to $90.9 million as of December 31, 2022.

Veteran C-Suite Executive Joins Revitalization Partners

Retrieved on: 
Wednesday, April 3, 2024
Consulting, Banking, Professional Services, Finance, SHARC, Partner, Organization, Software as a service, CFO, Business, Strategic planning, Sale, Dartmouth College, RP, Treasurer, Postgraduate education, MBA, NASA, Stanford University, Pacific Northwest, National Trust, Social science, Management

Revitalization Partners has announced that former corporate executive and senior advisor Richard von Riesen has joined the RP team.

Key Points: 
  • Revitalization Partners has announced that former corporate executive and senior advisor Richard von Riesen has joined the RP team.
  • Mr. von Riesen brings more than 30 years of experience in CEO, COO, and CFO roles as a senior financial, strategic planning and business development executive.
  • His resume features extensive experience in technology, retail, healthcare and aerospace, as well as the non-profit sector.
  • He recently served as Executive Chairman for a NASA -approved, scientific imaging company working on the agency’s spaceflight testing of launch and recovery systems.

ACB Names Scott Thornhill as New Executive Director

Retrieved on: 
Tuesday, March 19, 2024
Employment, Retinitis pigmentosa, Public policy, ACB, RP, University, Paratriathlon, National Association, Multimedia, Government, American Council, Management

ALEXANDRIA, Va., March 19, 2024 /PRNewswire/ -- Scott Thornhill took office today as the new Executive Director of the American Council of the Blind (ACB).

Key Points: 
  • ALEXANDRIA, Va., March 19, 2024 /PRNewswire/ -- Scott Thornhill took office today as the new Executive Director of the American Council of the Blind (ACB).
  • Thornhill was voted in by the ACB Board to lead the 62-year-old organization.
  • "It is an honor and a privilege to be able to lead an organization with such a rich history," said Thornhill.
  • "The strength of ACB is a combination of our members, our supporters, and the larger blindness community that we serve.

EudraVigilance registration manual

Retrieved on: 
Wednesday, April 3, 2024
Scroll, University, Data analysis, Patient, Account, Organization, MAH, Medicine, Manual, MFL, IAM, VAT, Finalize (optical discs), QAT, Competence, Documentation, Letter, Privacy, HQ2, ServiceNow, Environment, Trust (social science), RP, Table, Record, MPR, European Medicines Agency, Restricted area, Yahoo!, Identity management, Change request, Access, Qualified person (European Union), HQ, MMD, Home, Hospital, Research, Service, Network affiliate, Comment, Access management, OMS, Send, MSSO, ISO, Commercial, European, NCA, NCS, Managed services, Next, Document, EMA, PSMF, Language, MedDRA, AMP, Database, ICSR, Figure, EudraGMP, Dictionary, AMPS, Reproduction, Quality assurance, Identity, Virtual, Q2, SME, Change, Importance, Management, Security, Name, Location, Sponsor, Completeness, ID, 24 Hours, User, Vaccine
Key Points: 

    EudraVigilance registration documents

    Retrieved on: 
    Wednesday, April 3, 2024
    Community, Reproduction, EV, EudraVigilance, Annex, Letter, Regulation (European Union), European Parliament, Qualified person (European Union), Regulation, RP, OMS, EMA, Commercial, Request, Law, Marketing, European Medicines Agency, MAH, Council, EEA, Service, European, Clinical trial, ID, User, Register, Security printing

    Table of contents

    Key Points: 
      • Table of contents
        Pre-requisites .............................................................................................. 3
        Registration of the headquarter for Marketing Authorisation Holders
        (MAHs) ........................................................................................................ 3
        Registration of the headquarter for Commercial and Non-commercial
        sponsors ...................................................................................................... 4
        Registration of the headquarter of National Competent Authorities ............ 5

        EudraVigilance registration documents
        EMA/503894/2018

        Page 2/5

        Pre-requisites
        ?

        User registration in the EMA Account Management Portal ? see section 2.1 of the EudraVigilance
        Registration Manual.

      • ?

        Registration of the organisation in the Organisation Management System ? see section 3.3 of the
        EudraVigilance Registration Manual.

      • ?

        Request of the role, as applicable, ?EV MAH EU QPPV? or ?EV NCA Responsible? or ?EV CS/NCS
        Responsible? by the user via the EMA Account Management Portal ? see section 5.2 and Annex
        1 of the EudraVigilance Registration Manual.

      • ?

        Once the role has been requested in the EMA Account Management Portal, a Service Desk ticket
        should be raised to the Registration team, quoting the Request ID number and attaching the
        required documents listed below.

      • Registration of the headquarter for Marketing Authorisation
        Holders (MAHs)
        ?

        A cover letter from the headquarters level of the organisation on a company?s headed paper.

      • EudraVigilance registration documents
        EMA/503894/2018

        Page 3/5

        profile who has completed the courses and is related to the respective organisation.

      • Registration of the headquarter for Commercial and
        Non-commercial sponsors
        ?

        A cover letter from the headquarters level of the organisation on a company?s headed paper.

      • EudraVigilance registration documents
        EMA/503894/2018

        Page 4/5

        Registration of the headquarter of National Competent
        Authorities
        ?

        A cover letter on organisation?s headed paper.

    Radiology Partners Closes $720 Million Growth Equity Investment and Completes Previously Announced Debt Refinancing Transactions

    Retrieved on: 
    Thursday, February 22, 2024
    Technology, Hospitals, Health Technology, Software, Practice Management, Radiology, Health, Data Management, Artificial Intelligence, Sidley Austin, AI, MD, Investment, Growth, RP, Kirkland & Ellis, Patient, LLP, Centerview Partners, Partner, Security (finance)

    Radiology Partners (RP), the leading radiology practice in the U.S. through its owned and affiliated practices, today announced it has completed a series of previously announced financing transactions.

    Key Points: 
    • Radiology Partners (RP), the leading radiology practice in the U.S. through its owned and affiliated practices, today announced it has completed a series of previously announced financing transactions.
    • “Continued long-term support from our equity partners and lender partners fuels our mission and our ultimate success.
    • Meaningfully reduced its debt and successfully extended outstanding debt maturities with new maturity dates ranging from 2028 to 2030.
    • Will retain more than $500 million of cash and liquidity to fund continued growth and investment in innovation.

    jCyte, Inc. Announces Positive Pre-Phase 3 FDA Type B Meeting and Outlines Plans to Start Pivotal Trial of jCell® for Retinitis Pigmentosa in the Second Half of 2024

    Retrieved on: 
    Wednesday, February 21, 2024
    Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Retinitis pigmentosa, National Eye Institute, Doctor of Philosophy, Retina, MD, NIH, FDA, News, Food, Entrepreneurship, RP, Perseverance, UC, Patient, Clinical trial, Type, CMC, Pharmaceutical industry

    Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.

    Key Points: 
    • Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.
    • Sholar was also delighted with the FDA’s responses to jCyte’s description of its CMC program.
    • “We are pleased with the Type B meeting minutes, which enable us to move forward with the US pivotal trial.
    • The treatment has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and is administered as a minimally invasive intravitreal injection.

    KuCoin Unveils Account-Bound Tokens (KABT) with Reward Missions on Mocaverse and Halo Wallet

    Retrieved on: 
    Thursday, March 7, 2024
    Kucoin, Polygon, KYC, Growth, Reputation, RP, NFT, Ecosystem, Animoca Brands, Moda, Partnership, Cryptocurrency

    Partnering with Mocaverse and Halo Wallet, KABT allows users to engage in rewarding missions and unlock exclusive benefits within the KuCoin ecosystem while seamlessly navigating different realms of the Web3 world.

    Key Points: 
    • Partnering with Mocaverse and Halo Wallet, KABT allows users to engage in rewarding missions and unlock exclusive benefits within the KuCoin ecosystem while seamlessly navigating different realms of the Web3 world.
    • At the same time, KuCoin introduces rewarding missions through its exclusive partnerships with Mocaverse and Halo Wallet , marking a significant milestone in the KABT journey.
    • Hold KABT in Halo Wallet to earn Halo XP: Users can earn 2 Halo XP daily by holding a KABT in their Halo Wallet.
    • "We're thrilled to introduce KuCoin Account-Bound Tokens (KABT) and deepen our strategic partnership with Mocaverse and Halo Wallet with it," said Johnny Lyu, CEO of KuCoin.

    KuCoin Unveils Account-Bound Tokens (KABT) with Reward Missions on Mocaverse and Halo Wallet

    Retrieved on: 
    Thursday, March 7, 2024
    Kucoin, Polygon, KYC, Growth, Reputation, RP, NFT, Ecosystem, Animoca Brands, Moda, Partnership, Cryptocurrency

    Partnering with Mocaverse and Halo Wallet, KABT allows users to engage in rewarding missions and unlock exclusive benefits within the KuCoin ecosystem while seamlessly navigating different realms of the Web3 world.

    Key Points: 
    • Partnering with Mocaverse and Halo Wallet, KABT allows users to engage in rewarding missions and unlock exclusive benefits within the KuCoin ecosystem while seamlessly navigating different realms of the Web3 world.
    • At the same time, KuCoin introduces rewarding missions through its exclusive partnerships with Mocaverse and Halo Wallet , marking a significant milestone in the KABT journey.
    • Hold KABT in Halo Wallet to earn Halo XP: Users can earn 2 Halo XP daily by holding a KABT in their Halo Wallet.
    • "We're thrilled to introduce KuCoin Account-Bound Tokens (KABT) and deepen our strategic partnership with Mocaverse and Halo Wallet with it," said Johnny Lyu, CEO of KuCoin.