IMPD

Business Update

Retrieved on: 
Thursday, December 7, 2023
Workforce, Conference, IND, Sale, Oxford Biomedica, Acquisition, 5L, European, CDMO, 7L, Investigational New Drug, Lentivirus, COVID-19, AAV, Annual, IMPD, Growth, OXB, Vaccine

Oxford Biomedica has made significant progress in its streamlining of operations to become a pure-play quality and innovation-led global cell and gene therapy CDMO.

Key Points: 
  • Oxford Biomedica has made significant progress in its streamlining of operations to become a pure-play quality and innovation-led global cell and gene therapy CDMO.
  • This organisational restructuring is tailored to boost efficiency and client-centricity, aligning roles and operations with the specific requirements of a pure-play CDMO.
  • The Company continues to demonstrate robust business development activity, a testament to its strong position in the viral vector space.
  • The Company also remains on track to deliver broadly breakeven Operating EBITDA in 2024, bolstered by positive momentum in business development activities and new orders recently secured across lentivirus, adenoviral vectors and AAV, with both new and existing clients.

Rocket Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Progress

Retrieved on: 
Monday, November 6, 2023
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Consensus, Patient, Research, Busulfan, American College, CGMP, Genetic testing, Clinical trial, AAV, PDUFA, Incidence, IMPD, LV, Danon disease, Malignancy, Medication, Mortality, CMC, Conference, CTA, Acquisition, PKP2, Disease, JACC, Journal, Consensus decision-making, Priority review, Male, PKD, Natural history, MHRA, Disorder, EMA, Arrhythmia, Journal of the American College of Cardiology, LAMP2, Safety, Investment, Diagnosis, BLA, Pediatric Blood & Cancer, Pharmaceutical industry, Medical device, Security (finance), Fine chemical, G&A

Supported peer-reviewed expert consensus paper to increase awareness of diagnosis and clinical management of patients with Danon Disease.

Key Points: 
  • Supported peer-reviewed expert consensus paper to increase awareness of diagnosis and clinical management of patients with Danon Disease.
  • Highlights of the publication include a review of diagnosing Danon Disease emphasizing the importance of genetic testing upon clinical suspicion, natural history, management recommendations and recent advances in potential gene therapy treatment.
  • Rocket is working towards initiation of Phase 2 pivotal trial activities in Europe and the UK.
  • As of September 30, 2023, Rocket had cash, cash equivalents and investments of $437.2 million.

Akari Therapeutics Reports First Half 2023 Financial Results and Highlights

Retrieved on: 
Friday, September 29, 2023
Consensus, Manchester University NHS Foundation Trust, EBMT, Male, PRV, Ministry of Health (Poland), Medical device, IMPD, Civil service commission, Leukotriene B4, Blood, Priority review, Marketing, Health care, Clinical trial, Pediatrics, Royal Manchester Children's Hospital, Geographic atrophy, Committee on Herbal Medicinal Products, CTA, Medication, GA, Type, HSCT, Hot game, Hematopoietic stem cell transplantation, European Commission, Patient, NHS foundation trust, Akari, CFO, Diagnosis, Poster, Hospital, Regulatory affairs, European Society for Medical Oncology, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LTB4, Food, Autoimmunity, Safety, C5, Inflammation, Pharmaceutical industry, Nursing

Adult study design will be an important topic of discussion during a Type C meeting with the U.S. Food and Drug Administration (FDA) scheduled for November 15, 2023.

Key Points: 
  • Adult study design will be an important topic of discussion during a Type C meeting with the U.S. Food and Drug Administration (FDA) scheduled for November 15, 2023.
  • Akari was granted orphan drug designation from the European Commission for treatment in hematopoietic stem cell transplantation.
  • Akari also selected Wacker Biotech GmbH as the manufacturing partner to support production of PAS-nomacopan for use in clinical trials.
  • Akari appointed experienced life sciences executive Wendy DiCicco as interim Chief Financial Officer (CFO).

Commercial Manufacturing of Eftilagimod Alpha at 2000L Scale Granted Authorization for Clinical Trial Use

Retrieved on: 
Thursday, September 21, 2023
IMPD, MHC, Cancer, Head, ASX, Lung cancer, IMM, MHC class II, Patient, Autoimmune disease, WuXi Biologics, United Kingdom, Journal of Investigative Medicine, Pharmaceutical industry, Immutep

SYDNEY, AUSTRALIA, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the regulatory authorization of eftilagimod alpha (“efti”) manufactured at commercial 2,000L scale for use in clinical trials across multiple European countries including Germany, Belgium, Denmark, and the United Kingdom.

Key Points: 
  • SYDNEY, AUSTRALIA, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the regulatory authorization of eftilagimod alpha (“efti”) manufactured at commercial 2,000L scale for use in clinical trials across multiple European countries including Germany, Belgium, Denmark, and the United Kingdom.
  • After successfully scaling up the manufacturing process of efti to commercial scale at WuXi Biologics, the process-related changes were presented in a substantial amendment of the Investigational Medicinal Product Dossier (IMPD).
  • Overall comparability of the first 2,000L and the previous 200L scale clinical stage manufacturing process was achieved.
  • Immutep plans to introduce efti manufactured by the 2,000L scale process into current and future clinical trials.

Rocket Pharmaceuticals Reaches FDA Alignment on Pivotal Phase 2 Trial Design for RP-A501 in Danon Disease

Retrieved on: 
Tuesday, September 12, 2023
Research, FDA, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Science, NYHA, Male, CMS, LV, Troponin, IMPD, CMC, Center for Biologics Evaluation and Research, CTA, KCCQ, Disorder, Natriuresis, Medication, New York Heart Association Functional Classification, Food and Drug Administration Amendments Act of 2007, Clinical trial, CGMP, Patient, Heart transplantation, Immunohistochemistry, Mortality, Danon disease, Death, Food, Safety, Disease, Pharmaceutical industry, Medical device, EU, LAMP2

The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe.

Key Points: 
  • The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe.
  • A global natural history study will serve as an external comparator and run concurrently to the Phase 2 pivotal trial.
  • In-house manufacturing has been completed with sufficient high-quality drug product produced to fully supply the Phase 2 pivotal study.
  • Additionally, Rocket has secured an ICD-10 code from CMS for LAMP2 deficiency in Danon Disease

Poland and U.K. Regulatory Authorities – URPL and MHRA – Approve Use of New, Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Study

Retrieved on: 
Wednesday, March 29, 2023
Medical device, Ministry of Health (Poland), IMPD, Leukotriene B4, Health care, Advanced Therapy Medicinal Product, CTA, Medication, Part, Hot game, Therapy, LTB4, Autoimmunity, C5, Inflammation, Pharmaceutical industry

Third generation drug substance manufacturing process increases the final yield of nomacopan by at least 5-fold, improving cost efficiencies in the continuing Phase 3 clinical trial of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) advancing to pivotal Part B later this year

Key Points: 
  • Third generation drug substance manufacturing process increases the final yield of nomacopan by at least 5-fold, improving cost efficiencies in the continuing Phase 3 clinical trial of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) advancing to pivotal Part B later this year
    NEW YORK and LONDON, March 29, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced  regulatory authorities in Poland (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products/URPL) and the U.K. (Medicines & Healthcare products Regulatory Agency/MHRA) have approved amendments to the company’s Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Authorisation (CTA), respectively, for clinical use of the third-generation drug substance manufacturing process that increases the final yield of nomacopan by at least 5-fold.
  • Nomacopan is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4) currently in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
  • “The clearance by regulators in the U.K. and Poland of Akari’s newer, enhanced manufacturing process for nomacopan is another important step forward in our progress toward the pivotal Part B in our clinical trials in pediatric HSCT-TMA,” said Rachelle Jacques, President and Chief Executive Officer of Akari Therapeutics.
  • The Phase 3 study of nomacopan in pediatric HSCT-TMA includes clinical trial sites in Poland, the U.K. and U.S.

Pharmaceutical Development of ATMPs (Advanced Therapy Medicinal Products) Training Course (February 6-9, 2023) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 4, 2023
Education, Training, Pharmaceutical, Health, IMPD, Transport, Classification, GMP, ATMP, Pharmaceutical industry, Medical device, EU

The "Pharmaceutical Development of ATMPs Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharmaceutical Development of ATMPs Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs).
  • Industry experts will cover the regulatory landscape and the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges.
  • This seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.

Lassen Peak Appoints Civilian Oversight Authority, Anthony Finnell, to its Advisory Committee

Retrieved on: 
Thursday, July 14, 2022
Technology, Method, National Association, LLC, Program, Multimedia, Lassen Peak, Privacy, City, Law enforcement, School, CEO, IMPD, Policy, New Jersey State Parole Board, Director, Department of Defense Office of Inspector General, Indianapolis Metropolitan Police Department, Lead, Civil and political rights, Board, Management

BELLEVUE, Wash., July 14, 2022 /PRNewswire/ -- Today, Lassen Peak announces the appointment of Anthony Finnell to its advisory committee. Mr. Finnell is the owner of A. W. Finnell & Associates, LLC, a consulting firm specializing in civilian oversight of law enforcement, police practices, and policy development. Mr. Finnell is also a member of the Board of Directors for the National Association of Civilian Oversight for Law Enforcement (NACOLE) and formerly served as Strategic Initiatives Lead for the Office of Inspector General for the City of Seattle. Mr. Finnell began his career with the Indianapolis Metropolitan Police Department (IMPD), a law enforcement career that spanned over 20 years.

Key Points: 
  • BELLEVUE, Wash., July 14, 2022 /PRNewswire/ -- Today, Lassen Peak announces the appointment of Anthony Finnell to its advisory committee.
  • Mr. Finnell is the owner of A. W. Finnell & Associates, LLC, a consulting firm specializing in civilian oversight of law enforcement, police practices, and policy development.
  • Mr. Finnell began his career with the Indianapolis Metropolitan Police Department (IMPD), a law enforcement career that spanned over 20 years.
  • We understand the importance of proper supervision and oversight, and Anthony brings an authoritative perspective that will help enhance our understanding of the needs of the community."

PharmaTher Enters Into Process Development Agreement With LTS LOHMANN for Ketamine Microneedle Patch

Retrieved on: 
Monday, December 20, 2021
Investigational New Drug, LinkedIn, FDA, OTCQB, Ketamine, Infection, Administration, Journal of Investigative Medicine, MAP, Microneedle, Lists of diseases, IND, EMA, SVP, CEO, Needle, Inhalation, Research, Patient, CGMP, TTS, Mental health, IV, GLOBE, Twitter, Trial of the century, CSE, IMPD, Skin, LTS, Sour Patch Kids, OTF, Partnership, Pharmaceutical industry, Vaccine, EU

TORONTO and ANDERNACH, Germany, Dec. 20, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (PharmaTher) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine products, and LTS LOHMANN Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company, today announced they have entered into a process development agreement for the clinical trial scale up of PharmaThers proprietary Ketamine microneedle patch product.

Key Points: 
  • TORONTO and ANDERNACH, Germany, Dec. 20, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (PharmaTher) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine products, and LTS LOHMANN Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company, today announced they have entered into a process development agreement for the clinical trial scale up of PharmaThers proprietary Ketamine microneedle patch product.
  • Under the agreement, PharmaTher will cooperate with LTS in the process development and scale up of PharmaThers Ketamine microneedle patch product.
  • PharmaTher will be responsible for the planning and execution of clinical studies with the Ketamine microneedle patch product.
  • We are excited to work with LTS, a leader in transdermal delivery systems, to complete the clinical development of our ketamine microneedle patch product for clinical studies and scale up for future commercial use, said Fabio Chianelli, CEO of PharmaTher.

Forge Biologics Announces Key Hires in CDMO Operations and Medical Affairs, Company Presentations at World Orphan Drug Congress

Retrieved on: 
Wednesday, August 25, 2021
Research, Genetics, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Industry, CGMP, Michael F. Price College of Business, Downstream, University, Congress, Technology, Applications Technology Satellites, Growth, Therapy, Process, University of Navarra, Novozymes, AAV, IMPD, Molecular biology, Kwame Nkrumah University of Science and Technology, Business, Medical Affairs Bureau, Leadership, Texas A&M University, Chemical engineering, IESE Business School, Fermentation, R, Mascoma Corporation, Senior, Multimedia, Biotechnology, MBA, CDMO, University of Navarra School of Law, Upstream, IND, University of Oklahoma, Gaylord National Resort & Convention Center, CEO, Convention center, Hearth, ICM, Doctor of Philosophy, Quality control, Drug development, Management, Pharmaceutical industry

Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), announced today the expansion of its leadership team with two key hires in process development and medical affairs.

Key Points: 
  • Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), announced today the expansion of its leadership team with two key hires in process development and medical affairs.
  • Juan Ruiz, M.D., Ph.D., M.B.A., will lead the clinical development team as Senior Vice President, Medical Affairs; Frank Agbogbo, Ph.D., M.B.A., will head process development in CDMO operations.
  • Dr. Juan Ruiz joins the company with more than 20 years experience in drug development in biotechnology and academic environments in the field of gene therapy.
  • By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.