Journal of Investigative Medicine

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.

Propanc Biopharma Provides Shareholder Update

Retrieved on: 
Thursday, June 22, 2023
Research, General Health, Pharmaceutical, Oncology, Hospitals, Genetics, Clinical Trials, Science, Surgery, Biotechnology, FDA, Health, OTC Markets Group, PPCB, Pancreatic cancer, Patent, US Foods, Optimism, University, CSCS, Skin, United States Patent and Trademark Office, Calendar, European Patent Office, Clinical trial, Pharmacokinetics, Breast, Cancer, Brain, Prostate, IP, Doctor of Philosophy, Lung, US, Radiation, Hospital, PRP, Patient, Chymotrypsinogen, European Patent Convention, Trypsinogen, Form, Kidney, FIH, Canadian Intellectual Property Office, Growth, Liver, Annual report, Journal of Investigative Medicine, Gene, Tumor microenvironment, News, US FDA, Pharmacology, Safety, D, Pharmaceutical industry, Vaccine, Security (finance)

Propanc Biopharma, Inc. (OTC Pink: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, today announced a shareholder update including recent developments and forecast for 2023/24, as Propanc prepares to file a Form 10-K annual report, whose fiscal year end is June 30.

Key Points: 
  • Propanc Biopharma, Inc. (OTC Pink: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, today announced a shareholder update including recent developments and forecast for 2023/24, as Propanc prepares to file a Form 10-K annual report, whose fiscal year end is June 30.
  • Propanc recently filed a post-effective Form S-1 amendment on behalf the lead investor who has funded approximately $2.25 million to date.
  • Propanc plans to compile the Investigational Medicinal Product Dossier, study proposal and Investigator’s Brochure in 2023.
  • To date, Propanc has raised approximately $23 million dollars, culminating in the Company’s lead asset ready to commence clinical development, and a backup clinical compound entering preclinical stage.

New Qualified Person Oversight Regulations When Importing Investigational Medicinal Product to the UK, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, February 15, 2022
QP, Brexit, IMP, GMT, Journal of Investigative Medicine, MIA, IOR, Industry, Food, Medical device, EU, Sharp

TORONTO, Feb. 15, 2022 /PRNewswire-PRWeb/ --Qualified Person (QP) Oversight Know how the new rules for importing finished investigational medicinal products (IMPs) into Great Britain from approved countries affects a clinical trial supply?

Key Points: 
  • TORONTO, Feb. 15, 2022 /PRNewswire-PRWeb/ --Qualified Person (QP) Oversight Know how the new rules for importing finished investigational medicinal products (IMPs) into Great Britain from approved countries affects a clinical trial supply?
  • How will a supply chain be affected with the new QP oversight regulations introduced?
  • For more information, or to register for this event, visit New Qualified Person Oversight Regulations When Importing Investigational Medicinal Product to the UK.
  • Xtalks helps Life Science professionals stay current with industry developments, trends and regulations.

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.

DGAP-News: XPhyto Therapeutics Corp.: XPhyto Epilepsy Clinical Trial Planned in 2022 with Its Proprietary Fast-Dissolving CBD Oral Strips

Retrieved on: 
Monday, December 20, 2021
ODF, Therapy, GERMANY, FDA, Company, European Medicines Agency, Lennox–Gastaut syndrome, Infection, Pain, Clinical research center, Clinical trial, Journal of Investigative Medicine, US Foods, EMA, Neurology, Trial of the century, CAGR, Research, Patient, Dravet syndrome, CBD, CSE, Cannabinoid, Pharmaceutical industry, Epilepsy, BC

VANCOUVER, BC and UTTENWEILER, GERMANY / ACCESSWIRE / December 15, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) ("XPhyto" or the "Company") is pleased to provide an update on the development of its fast-dissolving CBD oral strips.

Key Points: 
  • VANCOUVER, BC and UTTENWEILER, GERMANY / ACCESSWIRE / December 15, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) ("XPhyto" or the "Company") is pleased to provide an update on the development of its fast-dissolving CBD oral strips.
  • Prof. Dr. Beckert said, "the clinical trial of our CBD product is aiming to demonstrate the efficient and precise dosing of the treatment.
  • If successful, this could make a significant difference to Epilepsy patients and we are excited to commence the trial next year."
  • XPhyto is developing a hybrid-generic CBD prescription drug formulation that employs the Company's proprietary oral dissolvable ("ODF") platform to deliver precise and efficient CBD dosages for the treatment of certain forms of childhood Epilepsy.

Lupus Foundation of America Awards Four Grants to Early Career Scientists, Supporting Crucial Areas of Research and Growth in the Field

Retrieved on: 
Monday, September 27, 2021
Lupus Foundation of America, Lupus, Journal of Investigative Medicine, Infection, Inflammation, Health, Patient, Lupus nephritis, Gary, IL-16, Kidney, CDA, Advisory Council, Scar, Growth, Government budget balance, MPH, Disease, Risk, Cognition, Research, Cell, Quality of life, Yale University, Doctor of Philosophy, Education, Rheumatology, Medicine, Pharmaceutical industry, Vaccine

WASHINGTON, Sept. 27, 2021 /PRNewswire/ --The Lupus Foundation of America is proud to announce the recipients of the 2021 Gary S. Gilkeson Career Development Award (CDA), a two-year grant focusing on critical lupus research while supporting early career scientists at the beginning of their careers, helping to ensure continued growth in the lupus research field.

Key Points: 
  • WASHINGTON, Sept. 27, 2021 /PRNewswire/ --The Lupus Foundation of America is proud to announce the recipients of the 2021 Gary S. Gilkeson Career Development Award (CDA), a two-year grant focusing on critical lupus research while supporting early career scientists at the beginning of their careers, helping to ensure continued growth in the lupus research field.
  • This year's grantees will focus their research on cognition, pediatric lupus, lupus nephritis and B-cell therapies.
  • Through a comprehensive program of research, education, and advocacy, we lead the fight to improve the quality of life for all people affected by lupus.
  • Learn more about the Lupus Foundation of America at lupus.org .