ANSM

Atamyo Therapeutics Obtains Regulatory Authorization in Europe to Initiate a Clinical Trial for ATA-200, its Gene Therapy to Treat Limb-Girdle Muscular Dystrophy Type 2C/R5

Retrieved on: 
Tuesday, March 26, 2024
Health, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, CNRS, Neurology, AAV, Motivation, Environment, Scientific method, Patient, CTA, DSM-IV codes, Biomarker, Research, ANSM, University, EMA, European Medicines Agency, Clinical trial, Therapy, Muscular dystrophy, Safety, Pathology, Weakness, Cardiomyopathy, Pharmaceutical industry

This authorization was first granted by the Italian Medicines Agency (AIFA), then by the French Medicines Agency (ANSM).

Key Points: 
  • This authorization was first granted by the Italian Medicines Agency (AIFA), then by the French Medicines Agency (ANSM).
  • Giacomo Comi, Full Professor of Neurology at the University of Milan (Italy), and principal investigator of this trial.
  • ATA-200, a gene therapy candidate for LGMD2C/R5, delivers a normal copy of the gene for production of γ-sarcoglycan protein.
  • In addition to its LGMD2C/R5 gene therapy, Atamyo is developing a clinical trial with ATA-100 gene therapy for LGMD2I/R9, related to deficiencies in FKRP; and is in IND-enabling studies for LGMD2A/R1, related to deficiencies in calpain protein.

GenSight Biologics Reports Full Year 2023 Consolidated Financial Results

Retrieved on: 
Friday, March 22, 2024
Health, Neurology, Genetics, Pharmaceutical, Optical, Biotechnology, Control, URD, Three-body problem, Safety, Partnership, Research, CIR, ANSM, CMC, EMA, BofA Securities, Risk, Chapter, MHRA, Clinical trial, European Investment Bank, ATU, AMF, Workforce, EIB, AAP, Marketing, FDA, Amendment, AAC, Cryptocurrency

From 2022 to 2023, the Company's research and development expenses remained stable, at €19.3 million in 2022 and €19.4 million in 2023.

Key Points: 
  • From 2022 to 2023, the Company's research and development expenses remained stable, at €19.3 million in 2022 and €19.4 million in 2023.
  • The Company's general and administrative expenses also remained stable and amounted to €5.4 million in 2022 and 2023.
  • The weighted average number of shares outstanding increased from 46.3 million in 2022 to 48.3 million in 2023, thereby reducing the loss per share from (€0.54) in 2023 to (€0.60) in 2023.
  • GenSight Biologics will report its cash position as of March 31, 2024 on April 4 2024.

Sensorion Reports Full-Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Bioreactor, Malignancy, Cell, Chemistry, Patient, Orphan, Good manufacturing practice, Health care, CMC, G&A, Molecular biology, Quality of life, European Medicines Agency, Science, Clinical trial, Cisplatin, Therapy, Hertz, Neoplasm, CIO, Congress, Huber loss, Partnership, Ageing, EMA, Hearing loss, GMP, Cochlea, Biochemistry, Safety, Language, Perilymph, G7, Medication, Control, AAV, PTA, IHC, Pasteur Institute, CDMO, Communication, Genetics, Research, KOL, Ear, POC, FDA, Ototoxicity, GJB2, ABR, CTA, ANSM, Audiogram, Platinum, Investment company, Congenital hearing loss, Pathology, Presbycusis, Hearing, Pharmaceutical industry

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.

Key Points: 
  • Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, said: “Over the past months, Sensorion has successfully achieved all the major milestones on its roadmap.
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV SENS-501 clinical batches at 200L scale.
  • On April 6, 2023, Sensorion announced the candidate selection for GJB2-GT during its gene therapy focused R&D Day.

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.

PHAXIAM Provides Business and Financial Update for the Third Quarter of 2023

Retrieved on: 
Tuesday, November 14, 2023
Webcast, Research, POC, European Medicines Agency, Lysin, Therapy, Infection, Conference call, Bank statement, S. aureus, Escherichia coli, S, Risk, Mortality, Phage therapy, EMA, ANSM, Patient, CET, AAC, FDA, Klebsiella pneumoniae, Fungal infection, Health, Pseudomonas aeruginosa, Partnership, CMC, IVD, EI, Cryptocurrency, Pharmaceutical industry, Dietary supplement, Medical device, Vaccine, Conference, Bloodstream infections

The enrollment is targeted to start by the end of 2023 and the first study results are expected in mid-2024.

Key Points: 
  • The enrollment is targeted to start by the end of 2023 and the first study results are expected in mid-2024.
  • Key financial figures for the first nine months of 2023 compared with the same period of the previous year are summarized below.
  • In the context of the Erytech-Pherecydes merger, PHAXIAM’s consolidated financial statements in IFRS standards include ex-Pherecydes financial results as from the date of the merger, i.e.
  • Consequently, PHAXIAM’s P&L information for the first 9 months of 2023 include 9 months of ex-Erytech activities and ex-Pherecydes activities since June 23, 2023.

PHAXIAM Therapeutics obtains authorizations to launch its phase 1 study in endocarditis infections caused by Staphylococcus aureus

Retrieved on: 
Tuesday, October 24, 2023
Fungal infection, Stroke, Phage therapy, Staphylococcus aureus, Incidence, National Agency for Food and Drug Administration and Control, Heart, Medication, Teaching hospital, Hope, Mortality, Endocarditis, Safety, ANSM, Infection, CEST, Pharmacokinetics, Endocardium, Clinical trial, S. aureus, Jean-Pierre du Teil, Bacteria, Blood, S, Therapy, Patient, Heart failure, CPP, Pharmaceutical industry

Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria.

Key Points: 
  • Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria.
  • The main cause of endocarditis infections, S. aureus, is responsible for around 30%1 of cases.
  • Pascal Birman, Chief Medical Officer of PHAXIAM Therapeutics, stated: "This phase 1 study was designed primarily to assess the safety and pharmacokinetics of our anti-S. aureus phages in the treatment of endocarditis infections.
  • The treatment of endocarditis infections caused by S. aureus using phage therapy could thus offer a major alternative and hope to many patients who have reached a therapeutic impasse.”

Amylyx Pharmaceuticals Provides Update on Accès Compassionnel for AMX0035 in France

Retrieved on: 
Thursday, October 5, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, European, ALS, European Directive on Traditional Herbal Medicinal Products, CHMP, Committee for Medicinal Products for Human Use, ANSM, European Medicines Agency, EMA, Marketing, Committee, Nursing, Vaccine, Amylyx Pharmaceuticals, AMX0035, EU

AMX0035 is known as RELYVRIO® in the United States and ALBRIOZA™ in Canada.

Key Points: 
  • AMX0035 is known as RELYVRIO® in the United States and ALBRIOZA™ in Canada.
  • For more information, including eligibility criteria, please visit here .
  • Separately, the formal re-examination procedure of the Marketing Authorisation Application of AMX0035 for the treatment of adults with ALS in the European Union (EU) remains underway.
  • Amylyx continues to engage with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to prioritize broad and sustainable access to AMX0035 through the central EU review and approval process.

PHAXIAM Provides Business and Financial Update For the First Half of 2023

Retrieved on: 
Thursday, September 21, 2023
DFU, Hip, Infection, IST, S. aureus, Bank statement, Fungal infection, Cutis marmorata telangiectatica congenita, Escherichia coli, Authorization, Financial statement, Staphylococcus, Trial of the century, Klebsiella pneumoniae, Pseudomonas aeruginosa, Diabetic foot ulcer, Patient, VAP, Risk, AAC, AMF, POC, Therapy, System, Diabetic foot, ANSM, Antibiotics, Pharmaceutical industry, Vaccine, Urinary tract infection, Lysin, Bloodstream infections

The company is awaiting a second AAC regulatory validation for PJI patients, associated with P. aeruginosa resistance from the ANSM.

Key Points: 
  • The company is awaiting a second AAC regulatory validation for PJI patients, associated with P. aeruginosa resistance from the ANSM.
  • On September 19, 2023, the company announced the extension of its portfolio to Klebsiella pneumoniae, a new resistant aggressive bacterial target.
  • Key financial figures for the first half of 2023 compared with the same period of the previous year are summarized below.
  • In the context of the Erytech-Pherecydes merger, PHAXIAM’s consolidated financial statements in IFRS standards include ex-Pherecydes financial results as of the date of the merger, i.e.

Sensorion Reports 2023 First Half Results

Retrieved on: 
Wednesday, September 20, 2023
Biotechnology, Pharmaceutical, General Health, Health, Medical Devices, Genetics, Clinical Trials, Other Health, GMP, US Foods, Ear, PTA, European Medicines Agency, Huber loss, G&A, Malignancy, Patient, Institut Pasteur Korea, R, Cisplatin, POC, Pasteur Institute, Good manufacturing practice, Hearing loss, Congenital hearing loss, Cochlear Limited, IHC, Bioreactor, Perilymph, EMA, Platinum, Ototoxicity, HIV disease progression rates, Hearing, CIO, FDA, IND, Health care, Cochlea, Cell, AAV, GJB2, Presbycusis, Audiogram, Hertz, ANSM, KOL, Partnership, Neoplasm, Concept, Clinical trial, Quality of life, CTA, Medication, CDMO, Orphan, Pharmaceutical industry, Dentistry, Vaccine, Medical device, Cryptocurrency, Rare-earth element

In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.

Key Points: 
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.
  • In April 2023, Sensorion announced the candidate selection for GJB2-GT during its R&D Day focusing on gene therapy.
  • The first patient was enrolled in December 2022 and Sensorion anticipates the publication of the preliminary results in H2 2023.
  • The annual accounts on June 30, 2023, drawn up according to IFRS standards and approved by the Board of Directors on September 18, 2023.

Crossject reports successful completion of European and U.S. audits for manufacturing of ZENEO® Midazolam for epileptic seizures

Retrieved on: 
Tuesday, September 5, 2023
BSI, Biomedical Advanced Research and Development Authority, Emergency, Office of Inspector General, U.S. Department of Health and Human Services, National Agency for Food and Drug Administration and Control, ISO, Safety, Human services, Food and Drug Administration, Medication, NextGen Healthcare, Certification, CGMP-specific phosphodiesterase type 5, Administration, Seizure, Development, CGMP, Administration for Strategic Preparedness and Response, ANSM, ISIN, FDA, BARDA, Food, Medical device, Pharmaceutical industry, Health, Euronext, Atlantic Ocean

‘‘These positive reports from both sides of the Atlantic are an important demonstration of Crossject’s stringent manufacturing and quality systems standards.

Key Points: 
  • ‘‘These positive reports from both sides of the Atlantic are an important demonstration of Crossject’s stringent manufacturing and quality systems standards.
  • These are essential for Crossject to ensure quality and bring our products to market in Europe and the United States,” said Patrick Alexandre, CEO of Crossject.
  • “ZENEO® Midazolam will provide a new, simple and reliable method of administering emergency treatment of status epilepticus seizures, delivering life-saving medicine rapidly and accurately.
  • Crossject Dijon and Gray sites met all the requirements for manufacturing and control of its auto-injector device under Quality Systems and CGMPs.