Swiss Medical Students' Association

Emergex Signs Contract of £1.79M with the UK Department of Health and Social Care’s UK Vaccine Network (“UKVN”) to Advance Its Novel Synthetic T Cell-Priming Set-Point Candidate Against Chikungunya Virus

Retrieved on: 
金曜日, 11月 17, 2023
UK Research and Innovation, Orthornavirae, Low, Good manufacturing practice, CHIKV, MHRA, Disease, DHSC, Government, Epitope, Epidemic, Research, Swiss Medical Students' Association, UKRI, Arthritis, Vaccine, AMR, CD8, Infection, CGMP, Pacific Ocean, News, RNA, Social work, Chikungunya, Dengue fever

In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.

Key Points: 
  • In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.
  • The programme is intended to position Emergex for entry to the clinic by its completion, ready to begin a Phase-1 clinical trial.
  • Subsequently, Emergex achieved all milestones priming the CHIKV candidate for progression to the next stage of its preclinical development.
  • A Phase-2 trial for CoronaTcP and a Phase-1 trial for a Universal Influenza vaccine candidate are planned in H1 2024.

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Retrieved on: 
火曜日, 9月 19, 2023
Medical Affairs Bureau, Central nervous system, Drug development, NDS, Therapy, Marketing, Type 2, Pediatrics, New Drug Application, European Medicines Agency, Health care, CMC, Clinical trial, NDA, Therapeutic Goods Administration, Cancer, CTA, Regulatory science, CNS, Common Technical Document, EMA, Chemistry, Shanda, Investigational New Drug, Patient, Pinnacle, Certara, Medicines and Healthcare products Regulatory Agency, MAA, Rare, TGA, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, BLA, Food, MHRA, Pharmaceutical industry, Risk management, Medical device, EU, Swiss Medical Students' Association

Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.

Key Points: 
  • Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.
  • “As the global regulatory drug development environment changes at an ever-increasing pace, Certara has combined regulatory writing expertise with technology platforms that streamline a complex process,” said Demetrius Carter, Sr. Vice President, Regulatory Sciences & Medical Affairs at Certara.
  • In addition to regulatory submission services, Certara offers a software portfolio that saves time and resources in submission development.
  • The software portfolio includes:
    Pinnacle 21™ software used to facilitate all aspects of preparing clinical trial data for regulatory submissions.