AEMPS

INmune Bio Receives EMA’s Authorization in France and Spain for Phase II Clinical Trial of XPro™ for Early Alzheimer’s Disease

Retrieved on: 
Monday, November 27, 2023
Phase, Patient, Alzheimer's disease, MRI, Sécurité, EMA, White matter, Brain, Inflammation, Medication, ANSM, Authorization, Biomarker, CTA, AEMPS, Pharmaceutical industry

This authorization follows the acceptance of the Company’s Clinical Trial Application (CTA) under EU Clinical Trials Regulation and prior EMA's Authorized Decision in Poland on Nov 15, 2023.

Key Points: 
  • This authorization follows the acceptance of the Company’s Clinical Trial Application (CTA) under EU Clinical Trials Regulation and prior EMA's Authorized Decision in Poland on Nov 15, 2023.
  • The Spanish and French arms are part of the Company’s international clinical development strategy for XPro™ in patients with early AD.
  • We believe clinical sites in these two countries will be significant contributors to the Phase II program and will be part of the global Phase III clinical trial,” said RJ Tesi M.D., CEO of INmune Bio.
  • The Phase II clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease who have biomarkers of elevated inflammation.

Decibel Therapeutics Announces Approval of Clinical Trial Application by the Spanish Agency of Medicines and Medical Devices (AEMPS) to Initiate Clinical Development of Lead Gene Therapy Candidate DB-OTO

Retrieved on: 
Friday, May 12, 2023
European Medicines Agency, Natural history, Medical device, Congenital hearing loss, COMP, ABR, Clinical trial, CTA, Medication, Spanish Agency of Medicines and Medical Devices, AAV, Committee, EMA, Investigational New Drug, Patient, AEMPS, Hearing, Decibel, Medicines and Healthcare products Regulatory Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, IND, Food, MHRA, Pharmaceutical industry

The Phase 1/2 dose escalation clinical trial, known as CHORD™, is designed to evaluate the safety, tolerability and efficacy of DB-OTO in pediatric patients with congenital hearing loss due to an otoferlin deficiency. In addition to safety and tolerability endpoints, the auditory brainstem response (ABR) -- an objective, clinically accepted, physiologic measure of hearing sensitivity -- will be used as an efficacy endpoint in the clinical trial. The ABR, which was used to characterize dose-response of DB-OTO after intra-cochlear delivery in translational studies in animal models, provides an opportunity to rapidly assess hearing functionality and sensitivity.

Key Points: 
  • BOSTON, May 12, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced approval of its Clinical Trial Application (CTA) by the Spanish Agency of Medicines and Medical Devices (AEMPS) to initiate a Phase 1/2 clinical trial in pediatric patients of DB-OTO, its lead gene therapy product candidate.
  • Medicines and Healthcare Products Regulatory Agency (MHRA) in January 2023.
  • Decibel expects that clinical trial participants in the U.K. and Spain will be infants two years of age and younger.
  • In addition to safety and tolerability endpoints, the auditory brainstem response (ABR) -- an objective, clinically accepted, physiologic measure of hearing sensitivity -- will be used as an efficacy endpoint in the clinical trial.

Decibel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Update

Retrieved on: 
Tuesday, March 14, 2023
Research, Spanish Agency of Medicines and Medical Devices, Sale, Clinical trial, Genetic distance, Medication, Brain, AEMPS, Good laboratory practice, CTA, ARO, Cisplatin, State Administrative Expenses, AAV, Ear, Development, Administration, Medicines and Healthcare products Regulatory Agency, Patient, MHRA, Midwinter, FDA, GJB2, Regeneron Pharmaceuticals, Medical device, Health care, Hearing, Investigational New Drug, Therapy, IND, Congenital hearing loss, Pharmaceutical industry, Otorhinolaryngology, Decibel

BOSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • BOSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.
  • Board of Directors Update: In October 2022, Decibel announced the appointment of Kevin F. McLaughlin to its Board of Directors.
  • Fourth Quarter and Full Year 2022 Financial Results:
    Cash Position: As of December 31, 2022, cash, cash equivalents and available-for-sale securities were $104.6 million, compared to $162.3 million as of December 31, 2021.
  • General and administrative expenses were $23.6 million for the full year 2022, compared to $20.4 million for the full year 2021.

Enlivex Receives Clearance From Spanish Agency of Medicines and Medical Devices For Treatment of Patients with Advanced Solid Malignancies in the Ongoing Allocetra Phase I/II Clinical Trial

Retrieved on: 
Thursday, February 23, 2023
Clinical trial, Safety, Therapy, Data monitoring committee, Immunotherapy, Ministry, MD, Health, Survival, Ovarian cancer, IND, Yale Cancer Center, Patient, AEMPS, Spanish Agency of Medicines and Medical Devices, Medical device, Medication, Food, Phase, Medicine, Pharmaceutical industry

Nes-Ziona, Israel, Feb. 23, 2023 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies.

Key Points: 
  • Nes-Ziona, Israel, Feb. 23, 2023 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies.
  • The Phase I/II multi-center clinical trial (clinicaltrials.gov Identifier: NCT05581719) has been designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra™ alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.
  • Einat Galamidi, MD., Vice President, Medical of Enlivex, stated "We are pleased with the AEMPS’ regulatory clearance to expand our clinical trial into Spain.
  • We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024.”

Online Academic Conferences Power International Academic Communication, Providing Domestic Young Scholars with World Stages

Retrieved on: 
Tuesday, February 14, 2023
Communications, Technology, Software, Other Communications, Research, Science, Media, Governance and Economic Management Assistance Program, Web of Science, CPCI, Print, Federal Reserve Bank of St. Louis, University of Pennsylvania Economics Department, University, AEPS, United Nations Department of Economic and Social Affairs, CNKI, Professor, Union, Federal Reserve Bank, Student, DOAJ, AEMPS, Multimedia, University of California, Information Systems International Conference, Graduate Student Organizing Committee, Communication, Conference, COVID-19, Political science, Policy, University of California, Davis, Springer, Video game, Economics

With the help of new media platforms and online meeting software, conference organizers gradually accomplished the conference transformation from offline to online.

Key Points: 
  • With the help of new media platforms and online meeting software, conference organizers gradually accomplished the conference transformation from offline to online.
  • These international academic conferences are providing more opportunities for Chinese scholars, especially the young to go abroad and communicate with peers from all over the world.
  • View the full release here: https://www.businesswire.com/news/home/20230212005042/en/
    The International Conference on Economic Management and Green Development (ICEMGD) is one of the representative international academic conferences using online approaches.
  • Over years, we have always been committed to professional support for scholars, no matter offline or online.

Curapath Receives Accreditation as a GMP Investigational Drug Product Manufacturer from the Spanish Agency for Medicine and Health Products

Retrieved on: 
Thursday, January 26, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, EMA, Therapy, LNP, AEMPS, Vaccine, European Medicines Agency, Safety, Accreditation, GMP, Spanish Agency of Medicines and Medical Devices, Medicine

Curapath, a leader in the design, development, and custom manufacturing of polyamino-acid- and lipid nanoparticle (LNP) delivery systems for therapeutics and vaccines, today announced the company has received accreditation as a GMP investigational drug product manufacturer from the Spanish Agency for Medicine and Health Products (AEMPS).

Key Points: 
  • Curapath, a leader in the design, development, and custom manufacturing of polyamino-acid- and lipid nanoparticle (LNP) delivery systems for therapeutics and vaccines, today announced the company has received accreditation as a GMP investigational drug product manufacturer from the Spanish Agency for Medicine and Health Products (AEMPS).
  • AEMPS is the regulatory agency that oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in Spain and acts as a representative of the European Medicines Agency (EMA).
  • “The authorization of manufacturing for clinical drug product from AEMPS is an exciting milestone for our facility in Spain,” said Robert Shaw, Chief Executive Officer of Curapath.
  • “The recognition of our capabilities by this regulatory body means that we can produce drug substance and drug product for our customers’ clinical programs.

Theriva Biologics Announces First Patient Dosed in VIRAGE, a Phase 2b Trial of Systemically Administered VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma

Retrieved on: 
Tuesday, January 17, 2023
AEMPS, SOC, Survival, Therapy, Incidence, Patient, PDAC, FDA, NYSE, Cancer, Pharmaceutical industry

ROCKVILLE, Md., Jan. 17, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the first patient has been dosed in VIRAGE, the Phase 2b randomized, open-label, placebo-controlled, multicenter clinical trial of systemically administered VCN-01 in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC).

Key Points: 
  • “The dosing of the first patient in our Phase 2b PDAC trial represents an important step in our pursuit to address unmet needs for patients with difficult-to-treat cancers,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
  • “The incidence of PDAC continues to rise and while it continues to have one of the lowest survival rates among all cancer types, efforts to improve upon the standard of care treatment have largely stalled.
  • In contrast, we are encouraged by the growing clinical data that underscore VCN-01’s differentiated mechanism of action, as well as the biological activity and synergistic clinical benefit observed in combination with SoC chemotherapy for patients with PDAC and other solid tumors.
  • With regulatory clearance from the FDA and AEMPS, we look forward to the continued progress of this program and more broadly, the advancement of our novel OV platform.”

Viralgen GMP certification rAAV commercial product

Retrieved on: 
Monday, January 9, 2023
European Medicines Agency, Certification, Spanish Agency of Medicines and Medical Devices, Rita Raave, Hope, Bayer, Therapy, Patient, MSAT, Research, AEMPS, SAN, Science, CDMO, Medical device, CGMP, EMA, Medication, Fine chemical, Pharmaceutical industry

SAN SEBASTIAN, Spain, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Viralgen Vector Core (Viralgen), an independently operated subsidiary of Asklepios BioPharmaceutical, Inc. (AskBio), and a member of the Bayer worldwide group of companies, has received Certified Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), a part of the European Medicines Agency (EMA) network. The company now operates two facilities in San Sebastian, Spain, with seven state-of-the-art single-use suites that have up to 2,000 liters of manufacturing capacity, making it a world-leading contract development and manufacturing organization (CDMO).  

Key Points: 
  • Viralgen receives cGMP certification to produce rAAV commercial grade product at new facility in San Sebastian, Spain
    -- New facility operates single-use bioreactors from 50 to 2,000 liters and manufactures research, clinical and commercial grade rAAV vectors using Pro10™, the leading cell line on the market --
    SAN SEBASTIAN, Spain, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Viralgen Vector Core (Viralgen), an independently operated subsidiary of Asklepios BioPharmaceutical, Inc. (AskBio), and a member of the Bayer worldwide group of companies, has received Certified Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances.
  • Viralgen is now licensed for the commercial manufacturing of recombinant adeno-associated virus (rAAV) gene therapies up to 2,000 liters and has completed seven successful runs at this maximum scale.
  • This first phase of the expansion of the new facility, which has added 300,000 square feet of clinical and commercial rAAV manufacturing, is now complete.
  • Viralgen is a fully integrated company, which supplies research, cGMP and commercial grade material from 250 to 2,000 liters in scale, including process development, formulation and filling.

Viralgen receives cGMP certification to produce rAAV commercial grade product at new facility in San Sebastian, Spain

Retrieved on: 
Monday, January 9, 2023
European Medicines Agency, Certification, Spanish Agency of Medicines and Medical Devices, Rita Raave, Hope, Bayer, Therapy, Patient, MSAT, Research, AEMPS, SAN, Science, CDMO, Medical device, CGMP, EMA, Medication, Fine chemical, Pharmaceutical industry

SAN SEBASTIAN, Spain, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Viralgen Vector Core (Viralgen), an independently operated subsidiary of Asklepios BioPharmaceutical, Inc. (AskBio), and a member of the Bayer worldwide group of companies, has received Certified Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), a part of the European Medicines Agency (EMA) network. The company now operates two facilities in San Sebastian, Spain, with seven state-of-the-art single-use suites that have up to 2,000 liters of manufacturing capacity, making it a world-leading contract development and manufacturing organization (CDMO).  

Key Points: 
  • Viralgen is now licensed for the commercial manufacturing of recombinant adeno-associated virus (rAAV) gene therapies up to 2,000 liters and has completed seven successful runs at this maximum scale.
  • This first phase of the expansion of the new facility, which has added 300,000 square feet of clinical and commercial rAAV manufacturing, is now complete.
  • The new facility currently has three independent state-of-the-art quality control labs and commercial manufacturing suites with 500- and 2,000-liter single-use bioreactors.
  • Viralgen is a fully integrated company, which supplies research, cGMP and commercial grade material from 250 to 2,000 liters in scale, including process development, formulation and filling.

Viralgen receives cGMP certification to produce rAAV commercial grade product at new facility in San Sebastian, Spain

Retrieved on: 
Monday, January 9, 2023
Bayer, Spanish Agency of Medicines and Medical Devices, European Medicines Agency, Research, Certification, Hope, MSAT, Science, SAN, AEMPS, CDMO, Patient, Medication, CGMP, Therapy, Rita Raave, EMA, Medical device, Fine chemical, Pharmaceutical industry

SAN SEBASTIAN, Spain, Jan. 9, 2023 /PRNewswire/ -- Viralgen Vector Core (Viralgen), an independently operated subsidiary of Asklepios BioPharmaceutical, Inc. (AskBio), and a member of the Bayer worldwide group of companies, has received Certified Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), a part of the European Medicines Agency (EMA) network. The company now operates two facilities in San Sebastian, Spain, with seven state-of-the-art single-use suites that have up to 2,000 liters of manufacturing capacity, making it a world-leading contract development and manufacturing organization (CDMO). 

Key Points: 
  • Viralgen is now licensed for the commercial manufacturing of recombinant adeno-associated virus (rAAV) gene therapies up to 2,000 liters and has completed seven successful runs at this maximum scale.
  • This first phase of the expansion of the new facility, which has added 300,000 square feet of clinical and commercial rAAV manufacturing, is now complete.
  • The new facility currently has three independent state-of-the-art quality control labs and commercial manufacturing suites with 500- and 2,000-liter single-use bioreactors.
  • Viralgen is a fully integrated company, which supplies research, cGMP and commercial grade material from 250 to 2,000 liters in scale, including process development, formulation and filling.