CRL

Charles River to Perform Plasmid Production for Ship of Theseus

Retrieved on: 
Thursday, April 4, 2024
Health, Medical Devices, Stem Cells, Genetics, General Health, Pharmaceutical, Biotechnology, Diabetes, Neutropenia, CDMO, Psoriasis, Infertility, Cancer, MCB, Tissue, CRL, DNA, Research, Pattern hair loss, HOX, Ship, Acquisition, Factorization of polynomials, Display resolution, GMP, Good manufacturing practice, Tecmar, Therapy, HQ, Vaccine

Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.
  • Ship of Theseus will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.
  • Charles River’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom will lead the collaboration, providing services that include plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank (MCB) generation, pre-production evaluation, and GMP plasmid DNA manufacture including in-house release testing.
  • We trust the team’s decades of success developing, producing, and reliably delivering plasmid DNA and look forward to bringing our therapies to patients.” – Jeremy Elser, Founding CEO, Ship of Theseus

Charles River Laboratories Showcases Technology-Driven Capabilities at AACR 2024

Retrieved on: 
Monday, April 1, 2024
Research, Medical Devices, Health Technology, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Lung cancer, Corporation, CRL, 3D, Doctor of Philosophy, Digital twin, IND, AACR, PDX, Paclitaxel, NCG, Poster, San Diego Convention Center, Corporate development, Medical imaging

Charles River Laboratories International, Inc. (NYSE: CRL) announced today that its industry-leading team of oncology experts will attend the American Association for Cancer Research (AACR) Annual Meeting .

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) announced today that its industry-leading team of oncology experts will attend the American Association for Cancer Research (AACR) Annual Meeting .
  • Charles River will present technology-driven capabilities and highlight the latest advancements in immuno-oncology, in vitro assays, and more.
  • The meeting is taking place from April 5-10, 2024, at the San Diego Convention Center in San Diego, California.
  • To learn more about Charles River’s research tools and services portfolio, visit booth #1121 at the AACR Annual Meeting 2024.

Charles River Laboratories Publishes 2023 Corporate Citizenship Report

Retrieved on: 
Wednesday, March 27, 2024
Stem Cells, Biotechnology, FDA, Professional Services, Health, General Health, Pharmaceutical, Environmental, Social and Governance (ESG), Medical Devices, Research, Science, Erg, Electricity, Certification, Integrity, Learning, ISMS, Biophysical environment, GHG, ESG, Patient, CRL, Refinement, GRI, Woman, Social, Responsibility, Sustainability accounting, TCFD, Task force, Corporate social responsibility, ISO, Food, Animal, Pharmaceutical industry

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the publication of its 2023 Corporate Citizenship Report , which includes progress and results from 2022 and 2023.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) today announced the publication of its 2023 Corporate Citizenship Report , which includes progress and results from 2022 and 2023.
  • The 2023 report demonstrates Charles River’s priorities and commitments across its strategic Environmental, Social and Governance (ESG) areas of focus: Accelerate Life-Saving Therapies; Lead with Integrity; Inspire our People; and Protect our Planet.
  • The 2023 Corporate Citizenship Report was prepared in accordance with the latest Global Reporting Initiative (GRI) Universal Standards, as well as the Sustainability Accounting Standards Board (SASB) Biotechnology and Pharmaceuticals Standard.
  • Visit the Corporate Citizenship section of Charles River’s website to read the 2023 Corporate Citizenship Report in its entirety and learn more about the Company’s ESG disclosures.

Charles River Announces Extension of Gene Therapy Manufacturing Alliance with NUS Yong Loo Lin School of Medicine

Retrieved on: 
Thursday, March 21, 2024
Research, Medical Devices, Genetics, Stem Cells, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Medical school, B cell, CDMO, NUS, CRL, DNA, Tecmar, HQ, National university, Vaccine

Charles River Laboratories International, Inc. (NYSE: CRL) and National University of Singapore’s (NUS) Yong Loo Lin School of Medicine (NUS Medicine), a leading medical education institution with a world-renowned medical research field of stem cell biology and therapy, today announced a High Quality (HQ) plasmid DNA development and manufacturing agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and National University of Singapore’s (NUS) Yong Loo Lin School of Medicine (NUS Medicine), a leading medical education institution with a world-renowned medical research field of stem cell biology and therapy, today announced a High Quality (HQ) plasmid DNA development and manufacturing agreement.
  • NUS Medicine will leverage this collaboration to access Charles River’s center of excellence, and established manufacturing platform, eXpDNA™.
  • In recent years, Charles River has significantly expanded its cell and gene therapy portfolio to streamline complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services.
  • Combined with the Company’s legacy testing capabilities, Charles River offers an industry-leading “concept to cure” advanced therapeutic solution.

Charles River and Navega Therapeutics Announce Comprehensive Gene Therapy Manufacturing Collaboration

Retrieved on: 
Thursday, March 14, 2024
Research, Medical Devices, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Erythromelalgia, AAV, Diabetic neuropathy, CDMO, Patient, CRL, Good manufacturing practice, Gene, DNA, CAP, Chronic pain, Doctor of Philosophy, GMP, Navega, Therapy, Peripheral neuropathy, CGT, Pharmaceutical industry

Charles River Laboratories International, Inc. (NYSE: CRL) and Navega Therapeutics , Inc., a biotechnology company developing epigenetic gene therapies, today announced an AAV9 production program agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Navega Therapeutics , Inc., a biotechnology company developing epigenetic gene therapies, today announced an AAV9 production program agreement.
  • As part of Charles River’s Cell and Gene Therapy (CGT) Accelerator Program (CAP), Navega will have access to established contract development and manufacturing (CDMO) capabilities and advisory services to produce an adeno-associated virus (AAV)-based gene therapy, NT-Z001, for Phase I clinical trials.
  • To bring NT-Z001 to clinic, Navega will leverage Charles River’s off-the-shelf plasmid products, custom plasmid capabilities, and Good Manufacturing Practice (GMP)-grade AAV production.
  • Join Ana Moreno, CEO, Navega Therapeutics on March 19 in San Francisco – see the full agenda and save your seat: https://bit.ly/3SW3VOV
    “The collaboration with Navega will tap into our premier gene therapy CDMO capabilities and robust AAV offerings.

Charles River Laboratories to Present at Barclays Global Healthcare Conference

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, General Health, Medical Devices, Health, Pharmaceutical, Conference, CRL, Barclays

Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it will present at the Barclays 26th Annual Global Healthcare Conference on Wednesday, March 13th, at 10:15 a.m.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it will present at the Barclays 26th Annual Global Healthcare Conference on Wednesday, March 13th, at 10:15 a.m.
  • Management will present an overview of Charles River’s strategic focus, business developments, and recent trends.
  • A live webcast of the presentation will be available through a link that will be posted on the Investor Relations section of the Charles River website at ir.criver.com .
  • A webcast replay will be accessible through the same website after the presentation and will remain available for at least two weeks.

Citius Pharmaceuticals Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Monday, March 18, 2024
T-cell lymphoma, PDUFA, Symantec Endpoint Protection, Letter, Disease, Patient, CRL, CTCL, Drug development, Safety, FDA, BLA, Food, Pharmaceutical industry

CRANFORD, N.J., March 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.

Key Points: 
  • "The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL.
  • "We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative.
  • We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.
  • The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.

Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, Lexicon, CRL, New Drug Application, FDA, CKD, Diabetes, Patient, Hearing, NDA, Pharmaceutical industry

THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.

Key Points: 
  • THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD).
  • The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.
  • “We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” said Lonnel Coats, Director and Chief Executive Officer.
  • Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance in order to engage in discussions regarding a path forward for resubmission and potential approval of the NDA.

ARS Pharmaceuticals Reviews Recent Clinical Updates and Commercial Opportunity at neffy® Investor Day

Retrieved on: 
Thursday, March 7, 2024
Type 1, Allergy, SAN, Anxiety, EMA, Caregiver, CRL, New Drug Application, ARS, FDA, Food, Larynx, University of South Florida, Anaphylaxis, Vomiting, Entrepreneurship, Symantec Endpoint Protection, Angioedema, University, Event, Tongue, Webcast, Patient, Pediatrics, Adrenaline, Population growth, Prescription, Irritation, Face, Pharmaceutical industry

The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.

Key Points: 
  • The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.
  • Of the patients that do fill their prescription, 80-90% either do not carry or use their treatment as indicated.
  • In late-February, the Company announced positive clinical data from a Phase 2 trial evaluating neffy in adults with chronic spontaneous urticaria.
  • The webcast replay and accompanying slides from today’s investor event may be accessed through the Events & Presentations page in the Investors & Media section of the Company's website.

Iterum Therapeutics Provides Business Update

Retrieved on: 
Wednesday, March 6, 2024
Infection, CRL, ITRM, Investment, FDA, Food, Sale, Therapy, NDA, Pharmaceutical industry

DUBLIN, Ireland and CHICAGO, March 06, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today provided a general business update.

Key Points: 
  • DUBLIN, Ireland and CHICAGO, March 06, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today provided a general business update.
  • Iterum announced that it now expects to resubmit its new drug application (NDA) for oral sulopenem to the U.S. Food and Drug Administration (FDA) in the first half of the second quarter of 2024, earlier than originally planned.
  • In January 2024, Iterum announced positive top-line results from the REASSURE trial and that it would be focusing on a strategic process to sell, license, or otherwise dispose of its rights to sulopenem with the goal of maximizing value for its stakeholders.
  • Iterum plans to engage a financial advisor in the near-term to assist management and the Board in evaluating Iterum’s strategic alternatives.