Scientific Advice Mechanism

1.463 Million Tons of Carbon Emissions Curtailed by NaaS in H1 2023, Ensuring Stability and Efficiency of Global Transport Energy System

Retrieved on: 
Friday, December 15, 2023
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Mr. Zhai ascribed the formidable challenge facing new energy development to three factors: "Source"--at supply side, renewable energy, in an intermittent, unstable and seasonal nature, makes an impact on stable grid operation; "Grid"--at operation side, surge of electricity leads to mounting pressure on grid operation and necessitates demand for grid regulation; "Charge"--at demand side, anxiety of charging and energy supply, as one of barriers in EV development, requires a more sound charging service network and higher percentage of high-power charging infrastructure, alongside solutions to eradicate range anxiety of EVs constrained by battery performance and capacity.

Key Points: 
  • In 2022, global carbon emissions from transport sector totaled 8.4 billion tons, roughly representing 24% of the world's total carbon emissions; and China's transport-related carbon emissions (1.258 billion tons+) accounted for 10.4% of China's total carbon emissions.
  • In other words, slashing carbon emissions in transport sector, which of paramount importance, is an unstoppable trend.
  • With digital technology and AI technology at the core, NaaS creates an "energy brain" for the future Internet of transport energy.
  • Serving to "Empower the World with Green Energy", NaaS, Mr. Zhai said, plans to cut China's transport-related carbon emissions by 10% or 1% of national carbon emissions.

Arthex announces regulatory milestones met in its program to develop ATX-01 in Myotonic Dystrophy Type 1

Retrieved on: 
Wednesday, December 14, 2022
Chemistry, DM1, Industrial technology, Drug discovery, Scientific Advice Mechanism, Development, Food, IND, Muscle, EMA, Toxicology, Patient, Orphan drug, Myotonic dystrophy, Disease, FDA, Fatigue, CMC, CTA, MicroRNA, ODD, European Medicines Agency, Hypersomnia, Science, CDTI, Tissue, Food and Drug Administration Amendments Act of 2007, FIH, Centre for the Development of Industrial Technology, Pharmaceutical industry

Importantly, no red flags or concerns were raised regarding the toxicology or rationale to support a FIH study.

Key Points: 
  • Importantly, no red flags or concerns were raised regarding the toxicology or rationale to support a FIH study.
  • Myotonic dystrophy type 1 (DM1) is a highly disabling disease affecting more than one million people worldwide.
  • Arthex Biotech is a preclinical-stage drug development company focused on improving the lives of patients with high unmet medical needs.
  • Arthex Biotech's investors are Invivo Capital, AdBio Partners, and the Centre for the Development of Industrial Technology (CDTI).

Arthex announces regulatory milestones met in its program to develop ATX-01 in Myotonic Dystrophy Type 1

Retrieved on: 
Wednesday, December 14, 2022
Chemistry, DM1, Industrial technology, Drug discovery, Scientific Advice Mechanism, Development, Food, IND, Muscle, EMA, Toxicology, Patient, Orphan drug, Myotonic dystrophy, Disease, FDA, Fatigue, CMC, CTA, MicroRNA, ODD, European Medicines Agency, Hypersomnia, Science, CDTI, Tissue, Food and Drug Administration Amendments Act of 2007, FIH, Centre for the Development of Industrial Technology, Pharmaceutical industry

Importantly, no red flags or concerns were raised regarding the toxicology or rationale to support a FIH study.

Key Points: 
  • Importantly, no red flags or concerns were raised regarding the toxicology or rationale to support a FIH study.
  • Myotonic dystrophy type 1 (DM1) is a highly disabling disease affecting more than one million people worldwide.
  • Arthex Biotech is a preclinical-stage drug development company focused on improving the lives of patients with high unmet medical needs.
  • Arthex Biotech's investors are Invivo Capital, AdBio Partners, and the Centre for the Development of Industrial Technology (CDTI).

Mindset Pharma CEO, James Lanthier Issues Letter to Shareholders

Retrieved on: 
Wednesday, November 30, 2022
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TORONTO, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (Mindset or the Company) today issued a letter to shareholders from James Lanthier, Chief Executive Officer of Mindset.

Key Points: 
  • TORONTO, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (Mindset or the Company) today issued a letter to shareholders from James Lanthier, Chief Executive Officer of Mindset.
  • Mindset is focused on a singular goal to bring best-in-class optimized psychedelic medications to patients in need.
  • Mindset has an unmatched track record of strategically partnering with organizations that can help us advance and commercialize our innovations.
  • Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs.

Quoin Pharmaceuticals Provides Corporate Update and Announces Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 10, 2022
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ASHBURN, Va., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the Company or Quoin), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today provides a business update and announces financial results for the third quarter, ended September 30, 2022.

Key Points: 
  • ASHBURN, Va., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the Company or Quoin), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today provides a business update and announces financial results for the third quarter, ended September 30, 2022.
  • During the quarter, we also established a website to facilitate patient awareness and participation in the study.
  • In July 2022, Quoin Pharmaceuticals announced the opening of the first clinical site for its clinical study to evaluate QRX003 for the treatment of the rare genetic disease, Netherton Syndrome.
  • A majority of clinical sites are now fully open and the remaining sites are expected to open in the fourth quarter of 2022.

EQS-News: Broad-acting antiviral SARS-CoV-2 drug FYB207 shows longer half-life and improved efficacy through optimized molecular design in preclinical studies

Retrieved on: 
Monday, November 7, 2022
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Press Release // November 3, 2022

Key Points: 
  • Press Release // November 3, 2022
    Munich Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published preclinical in vivo results for the development of their COVID-19 drug FYB207.
  • Thus, the FYB207 lead candidate, unlike vaccines and neutralizing antibodies, retains its full antiviral potential against SARS-CoV-2 variants of concern.
  • "The performed pre-clinical studies and the available data from the lead candidates form an important milestone in the development of our COVID-19 drug.
  • Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.

Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Retrieved on: 
Wednesday, September 14, 2022
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The MHRA has agreed with the Companys position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time.

Key Points: 
  • The MHRA has agreed with the Companys position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time.
  • The MHRA has also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.
  • Given its differentiation and improved pharmacological profile, Mindset prioritized moving MSP-1014 to first-in-human clinical studies.
  • We are thrilled to have received this favorable written guidance from the MHRA, confirming the readiness of MSP-1014 for Phase 1 first-in-human clinical development.

Myrtelle’s rAAV-Olig001-ASPA Gene Therapy Candidate for Canavan Disease Receives Advanced Therapy Medicinal Product Classification from the European Medicines Agency

Retrieved on: 
Wednesday, September 7, 2022
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Myrtelle Inc., (Myrtelle or the Company), a clinical stage gene therapy company focused on developing transformative treatments for neurodegenerative diseases, today announced that the European Medicines Agency (EMA) has classified the Company's lead gene therapy product candidate, rAAV-Olig001-ASPA for the treatment of Canavan disease, as an Advanced Therapy Medicinal Product (ATMP), specifically a Gene Therapy Medicinal Product (GTMP).

Key Points: 
  • Myrtelle Inc., (Myrtelle or the Company), a clinical stage gene therapy company focused on developing transformative treatments for neurodegenerative diseases, today announced that the European Medicines Agency (EMA) has classified the Company's lead gene therapy product candidate, rAAV-Olig001-ASPA for the treatment of Canavan disease, as an Advanced Therapy Medicinal Product (ATMP), specifically a Gene Therapy Medicinal Product (GTMP).
  • The production of myelin is affected in CD due to a mutation in the Aspartoacylase gene (ASPA) leading to deficiency in Aspartoacylase enzyme (ASPA).
  • "The designation by the EMA of rAAV-Olig001-ASPA as a Gene Therapy Medicinal Product as a potential treatment for patients with Canavan disease provides important benefits in the development of this innovative therapy.
  • More information on Myrtelles clinical study in Canavan disease can be found on https://clinicaltrials.gov/ under the identifier NCT04833907 or by emailing [email protected] .

Coave Therapeutics Strengthens Leadership Team with the Appointments of Catherine Mathis as Vice President Regulatory Affairs and Julien Berger as Head of Legal Affairs

Retrieved on: 
Tuesday, September 6, 2022
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PARIS, Sept. 6, 2022 /PRNewswire/ -- Coave Therapeutics ('Coave'), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, today announced the appointments of Catherine Mathis, PharmD, as Vice President Regulatory Affairs and Julien Berger, as Head of Legal Affairs.

Key Points: 
  • PARIS, Sept. 6, 2022 /PRNewswire/ -- Coave Therapeutics ('Coave'), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, today announced the appointments of Catherine Mathis, PharmD, as Vice President Regulatory Affairs and Julien Berger, as Head of Legal Affairs.
  • Ms. Mathis will define and oversee the regulatory strategy and operations supporting the advancement of Coave's programs.
  • "We are delighted to welcome Catherine and Julien to the team at Coave.
  • He joins Coave from Galapagos where he served as Senior Legal Counsel Director providing legal support and advice to its global teams.

Coave Therapeutics Strengthens Leadership Team with the Appointments of Catherine Mathis as Vice President Regulatory Affairs and Julien Berger as Head of Legal Affairs

Retrieved on: 
Tuesday, September 6, 2022
European Medicines Agency, Legal Affairs, University, EMA, Doctor of Pharmacy, Corporation, CEO, Master, Sanofi Pasteur, Degenerative disease, IND, Scientific Advice Mechanism, Therapy, Central nervous system, US Foods, R, Eye, Head, Food, Genzyme, Katherine, Sangamo Therapeutics, Ipsen, Sanofi, Re Recher's Will Trusts, Transgene, Company, Regulatory affairs, FDA, Toxicology, Science, Growth, Acquisition, Corporate law, CNS, Pharmaceutical industry, Fine chemical, Medicine, EU, Idinvest Partners, University of Paris

PARIS, Sept. 6, 2022 /PRNewswire/ -- Coave Therapeutics ('Coave'), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, today announced the appointments of Catherine Mathis, PharmD, as Vice President Regulatory Affairs and Julien Berger, as Head of Legal Affairs.

Key Points: 
  • PARIS, Sept. 6, 2022 /PRNewswire/ -- Coave Therapeutics ('Coave'), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, today announced the appointments of Catherine Mathis, PharmD, as Vice President Regulatory Affairs and Julien Berger, as Head of Legal Affairs.
  • Ms. Mathis will define and oversee the regulatory strategy and operations supporting the advancement of Coave's programs.
  • "We are delighted to welcome Catherine and Julien to the team at Coave.
  • He joins Coave from Galapagos where he served as Senior Legal Counsel Director providing legal support and advice to its global teams.