ANSM

Cryoport Acquires Cell&Co BioServices

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월요일, 4월 18, 2022
EMEA, ISO, Twitter, Quality control, ANSM, QP, Risk, Annual report, Collection, Private Securities Litigation Reform Act, Medicine, Reproductive medicine, ISO 9001, Patient, Regenerative medicine, CO, NFS, Nasdaq, Company, U.S. Securities and Exchange Commission, Laboratory, SEC, BD (company), Industry, Multimedia, Acquisition, View, Cell, Time, Fine chemical, EU

NASHVILLE, Tenn., April 18, 2022 /PRNewswire/ -- Cryoport, Inc. (Nasdaq: CYRX) ("Cryoport" or the "Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced that it has acquired Cell&Co BioServices, headquartered in Clermont-Ferrand, France with additional operations in Pont-du-Château, France. Founded in 2012, Cell&Co is a bioservices business providing biorepository, kitting, and logistics services to the life sciences industry. Its accreditations include ISO 9001, ANSM (Investigational Medicinal Products), NFS 96 900, and soon, ISO 20387. Supporting its biostorage and services of clinical and commercial biopharma therapies, Cell&Co has in-house QP services.

Key Points: 
  • NASHVILLE, Tenn., April 18, 2022 /PRNewswire/ -- Cryoport, Inc. (Nasdaq: CYRX) ("Cryoport" or the "Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced that it has acquired Cell&Co BioServices, headquartered in Clermont-Ferrand, France with additional operations in Pont-du-Chteau, France.
  • Founded in 2012, Cell&Co is a bioservices business providing biorepository, kitting, and logistics services to the life sciences industry.
  • Regarding the acquisition, Jerrell Shelton, Chief Executive Officer of Cryoport, stated, "We are indeed pleased to have the Cell&Co team as a part of Cryoport.
  • Cell&Co will play a significant role in Cryoport Systems' development of its Global Supply Chain Network, designed to meet the needs of the growing Regenerative Medicine industry worldwide.

ABIONYX Announces Positive Clinical Findings for CER-001 in Treating COVID-19, Published in Biomedecines, Demonstrating That CER-001 Limits Inflammation Effects

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목요일, 3월 24, 2022
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Risk, Cytokine, CAA, LDL, COVID-19, Research, Patient, Proning, Medicine, Health, Degenerative disease, Injection, Inflammation, HDL, ANSM, PEA, ICU, Sepsis, Protein, Proteomics, Disease, Pharmaceutical industry, Vaccine

COVID-19 is associated with respiratory symptoms characterized by acute lung injury, rapidly progressing to acute respiratory distress syndrome.

Key Points: 
  • COVID-19 is associated with respiratory symptoms characterized by acute lung injury, rapidly progressing to acute respiratory distress syndrome.
  • Decreased levels of total cholesterol, LDL and HDL have been observed in patients with COVID-19 infections.
  • Patients with low HDL levels at hospital admission have an increased risk of developing severe disease compared with patients with high HDL levels.
  • HDLs have been shown to reduce inflammation in models of bacterial sepsis in part via their ability to bind and remove circulating endotoxins.

KELIX bio Enters Into a Binding Commitment to Acquire PHI, a Leading Pharmaceutical Manufacturer in Morocco

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화요일, 3월 8, 2022
Biotechnology, Pharmaceutical, Health, Leadership, Population, AMO, European Bank for Reconstruction and Development, ANSM, Medication, CDC Group, PHI, GMP, Emerging market, European Central Bank, Reconstruction, CDC, Campbell Alliance, Fine chemical, Pharmaceutical industry, Public relations, Kingdom, Nadir Sedrati

KELIX bio, a unique pan-African biopharmaceutical platform, today announced it has entered into a binding commitment to acquire Pharmaceutical Institute (PHI), a leading pharmaceutical company established in Rabat.

Key Points: 
  • KELIX bio, a unique pan-African biopharmaceutical platform, today announced it has entered into a binding commitment to acquire Pharmaceutical Institute (PHI), a leading pharmaceutical company established in Rabat.
  • PHI was established in 1989 by the Sedrati family and is a leading manufacturer and distributor of pharmaceutical products in Morocco.
  • We are privileged to have reached an agreement with the founders and look forward to welcoming them to KELIX bio, said Hocine Sidi-Said, Chief Executive Officer at KELIX bio.
  • About KELIX bio: KELIX bio, is a specialty generic business focused on Emerging Markets that seeks to compete through innovation and cost leadership.

MaaT Pharma Reports Cash and Revenues for Full-Year 2021

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월요일, 2월 28, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Use, Annual, Company, Graft-versus-host disease, Euronext Paris, Agence nationale de sécurité du médicament et des produits de santé, ANSM, CET, Biomarker, Cancer, Conference, Forward-looking statement, Patient, Special access program, Survival, Atun, History, IPO, CEO, CGMP, Pharmaceutical industry, Euronext, EUR

MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer today reported its cash position as of December 31, 2021, and its full-year 2021 revenues.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer today reported its cash position as of December 31, 2021, and its full-year 2021 revenues.
  • 2021 has been an eventful year for MaaT Pharma.
  • As of December 31, 2021, total cash and cash equivalents were EUR 43.3 million, as compared to EUR 19.9 million as of December 31, 2020.
  • MaaT Pharma is the first company developing microbiome-based therapies listed on Euronext Paris (ticker: MAAT).

Synapse Medicine raises €25M to help patients and healthcare professionals globally in the better use of medicines

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화요일, 3월 1, 2022
National Agency for Food and Drug Administration and Control, Software as a service, Lan Xang, Insurance, Algorithm, International, Culture, Stanford University, Public health, BNP Paribas, Digital economy, Enterprise, Committee on Safety of Medicines, Medicine, Institute, Digital, Venture, ANSM, Hospices Civils de Lyon, Enterprise Data Planning, Artificial intelligence, AP-HP, Safety, Decision-making, Death, Traction, Patient, Technology, National Center for Medical Intelligence, CEO, Hospital, Health insurance, Pharmaceutical industry, Cryptocurrency, Financial technology, Ledger, Glovo

BORDEAUX, France, March 1, 2022 /PRNewswire/ --

Key Points: 
  • Composed of artificial intelligence algorithms, it provides a complete view of medicine related information, thereby facilitating decision making for health professionals.
  • Today the team is composed of experienced individuals who are all united in the desire to help healthcare professionals and patients on a daily basis.
  • "We are once again supporting the deployment of Synapse Medicine, a start-up that we spotted at a very early stage.
  • This fund-raising will enable us to reinforce the team and continue to help health professionals and patients globally" says Clement Goehrs, CEO and co-founder of Synapse Medicine.

AB Science granted authorization to initiate confirmatory Phase III trial of masitinib in progressive forms of multiple sclerosis by the Swedish Medical Products Agency

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수요일, 2월 2, 2022
Multiple sclerosis, Risk, Immune system, Cell, Pengkhianatan G30S/PKI, Veterinary medicine, Research, MRI, Autoimmune disease, Safety, B cell, Patient, Neurodegeneration, Lists of diseases, Inflammation, ALS, Microglia, Marketing, Company, Immunology, Survival, Tyrosine kinase inhibitor, Medical Products Agency (Sweden), Euronext, AMF, Scientific Committee on Antarctic Research, PPMS, European Medicines Agency, ANSM, Treatment, Neurology, Magnetic resonance imaging, Amyotrophic lateral sclerosis, Central nervous system, Degenerative disease, Macrophage, Euronext Paris, Disease, Medicine, NSPM, AB, European Committee of the Regions, Science, Disability, EDSS, Pharmaceutical industry, Medical imaging, Vaccine, Masitinib

AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).
  • To date, masitinib has demonstrated positive Phase 2B/3 results in three neurodegenerative disorders, namely, Alzheimers disease [1], amyotrophic lateral sclerosis (ALS) [2,3], and progressive forms of multiple sclerosis [4].
  • This confirmatory study follows successful completion of a first Phase 2B/3 study (AB07002) in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis.
  • Published 2021 Jul 19. doi:10.1177/17562864211030365
    [4] Vermersch P, Hermine O. Masitinib in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis: results from phase 3 study AB07002.

Panaxia and Neuraxpharm: First export of medical cannabis sublingual tablets to France

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월요일, 1월 24, 2022
Permira, EU, Multiple sclerosis, Cancer, Patient, Medication, Palliative care, Central nervous system, Safety, Liver, TEL, CNS, Tablet, Pharmacy, General manager, Database, Probiotic, Patient satisfaction, Absorption, Physician, CEO, LL, Pain, Marketing, Program, TASE, Quality of life, MS, Doctor of Philosophy, National Agency for Food and Drug Administration and Control, Hospital, ANSM, McNeil Consumer Healthcare, Pharmaceutical industry, Drug, Generic drug, Tourism, Epilepsy

In addition, we are the only company in this program to supply medical cannabis sublingual tablets.

Key Points: 
  • In addition, we are the only company in this program to supply medical cannabis sublingual tablets.
  • According to our predictions, the French market is expected to become one of the most advanced medical cannabis markets in the world, which will be a remarkable growth engine for Panaxia".
  • As the only companies in the program providing medical cannabis sublingual tablets, we are able to offer our patients a variety of patient-oriented and more easy-to-use forms of presentation.
  • The market potential in France is very significant, considering only last year the French government approves the regulatory of the medical cannabis industry.

AB Science has been granted authorization to initiate Phase II study in patients with severe mast cell activation syndrome by the French Health Authority (ANSM)

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수요일, 1월 19, 2022
Medicine, Euronext Paris, Survival, Patient, Research, Scientific Committee on Antarctic Research, B cell, Apoptosis, KOL, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PKI, AMF, Population, Safety, Diagnosis, Science, Lists of diseases, Degenerative disease, Disease, Smouldering, AB, Tyrosine kinase inhibitor, Tissue, Marketing, Itch, Emmanuel Berl, Company, Mast cell activation syndrome, Depression, PLOS One, Veterinary medicine, MCAS, Food, Inflammation, FDA, Prevalence, Cell, Euronext, ANSM, Glass, Molders, Pottery, Plastics and Allied Workers International Union, Lancet, Pharmaceutical industry, Vaccine, Mastocytosis

AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the French Medicine Agency, ANSM, to initiate a Phase II study (AB20006) in patients with severe mast cell activation syndrome.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the French Medicine Agency, ANSM, to initiate a Phase II study (AB20006) in patients with severe mast cell activation syndrome.
  • MCAS is a disease caused by inappropriate activation of mast cells, which can lead to mast cell mediator release symptoms with a severity ranging from mild to life-threatening.
  • Systemic mast cell activation disease: the role of molecular genetic alterations in pathogenesis, heritability and diagnostics.
  • AB Science disclaims any obligationor undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq.

Eurofins CDMO Expands Spray Drying Capabilities

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화요일, 1월 11, 2022
Biotechnology, Pharmaceutical, Health, PMDA, FAMHP, Contract, EMA, CDMO, Genomics, Life, Health Canada, Product-service system, Development, Spray drying, GMP, ANSES, View, Formulation, Solubility, Pharmacology, Food, Environment, FDA, Contract research organization, Laboratory, API, Active ingredient, ANSM, Fine chemical, Eurofins Scientific, Eurofins CDMO, Eurofins – the global leader in bio-analysis, EUROFINS CDMO, EUROFINS – THE GLOBAL LEADER IN BIO-ANALYSIS

Eurofins CDMO announces the expansion of existing Spray Dry Development & Production Services in North America.

Key Points: 
  • Eurofins CDMO announces the expansion of existing Spray Dry Development & Production Services in North America.
  • The Canadian facility, located in Mississauga, ON, has expanded its cGMP Spray Drying capabilities with the addition of a GEA Mobile Minor spray drying system and dedicated 500 sq.
  • With this expansion, Eurofins CDMO can further complement a broad range of services specializing in solubility enhancement for clinical development and small scale commercial programs.
  • The expansion of Spray Drying at Eurofins CDMO provides continued support of clinical development programs where formulation enabling is required for poorly soluble compounds.

InFlectis BioScience Receives Approval from French Regulatory Authority to Conduct a Phase 2 Clinical Trial for IFB-088 (Icerguastat) for the Treatment of Amyotrophic Lateral Sclerosis

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월요일, 1월 10, 2022
Safety, Amyotrophic lateral sclerosis, Charcot–Marie–Tooth disease, Amyotrophy, Disease, Protein, ANSM, Patient, Degenerative disease, ALS, Integrated stress response, BioScience, CMT, SAS, Therapy, ISR, Riluzole, Pharmaceutical industry, Telescopic sight

Nantes, France--(Newsfile Corp. - January 10, 2022) - InFlectis BioScience SAS, a clinical-stage company developing innovative therapeutics for neuromuscular diseases by harnessing the Integrated Stress Response (ISR), receives approval from the French Regulatory Authority ANSM to start a Phase 2 clinical trial evaluating IFB-088 for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Key Points: 
  • Nantes, France--(Newsfile Corp. - January 10, 2022) - InFlectis BioScience SAS, a clinical-stage company developing innovative therapeutics for neuromuscular diseases by harnessing the Integrated Stress Response (ISR), receives approval from the French Regulatory Authority ANSM to start a Phase 2 clinical trial evaluating IFB-088 for the treatment of Amyotrophic Lateral Sclerosis (ALS).
  • The study is a double-blind, placebo-controlled, exploratory randomized clinical trial to assess the safety and efficacy of IFB-088.
  • InFlectis BioScience is a France-based clinical stage company developing first-in-class therapies for neuromuscular diseases.
  • InFlectis drug candidates keep this command center operating to prevent downstream effects that lead to disease.