Danish Medicines Agency

Enlivex Announces Authorization from the Danish Regulatory Agency for the Company’s Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis

Retrieved on: 
화요일, 4월 16, 2024
Phase, Knee, Safety, Data monitoring committee, Osteoarthritis, Immunotherapy, Injection, Patient, Danish Medicines Agency, Ministry, Therapy, Danish, Pharmaceutical industry

As previously announced, the Company received its first regulatory approval for this trial from the Israeli Ministry of Health (IMOH) in January.

Key Points: 
  • As previously announced, the Company received its first regulatory approval for this trial from the Israeli Ministry of Health (IMOH) in January.
  • The Phase I/II multi-center trial is composed of two stages.
  • In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee.
  • Oren Hershkovitz, Ph.D., CEO of Enlivex, commented “We are excited to push ahead with the clinical development of AllocetraTM in osteoarthritis.

The RWE ROI Series: The Transformational Value of Real-World Data for Drug Development and Regulatory Decision-Making, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
목요일, 1월 12, 2023
Disease, Danish Medicines Agency, HMA, R, Digital, Janssen Pharmaceuticals, RWD, Risk, Danish, Strategy, Data science, Drug development, RWE, Patient, Research, Digital health, Medical device, Pharmaceutical industry

TORONTO, Jan. 12, 2023 /PRNewswire-PRWeb/ -- The value of real-world data is clear. The acceptance of real-world evidence (RWE) is growing. But is this enough to propel RWE from being a nice-to-have to a must-have?

Key Points: 
  • TORONTO, Jan. 12, 2023 /PRNewswire-PRWeb/ -- The value of real-world data is clear.
  • This webinar will explore relevant examples of how Data Science and Digital Health are accelerating pharmaceutical innovation and driving impact for patients.
  • Bringing together global experts with diverse perspectives spanning regulatory, R&D and health tech, this conversation will highlight innovative, RWD-driven approaches to drug development and regulatory decision-making.
  • Register today to learn more about the transformational value of real-world data for drug development and regulatory decision-making.

UNION therapeutics receives FDA Fast Track designation for oral orismilast for the treatment of moderate to severe hidradenitis suppurativa

Retrieved on: 
화요일, 1월 10, 2023
Hidradenitis suppurativa, Dermatology, Food, MD, Infection, OSIRIS, Ethics, Zealand University Hospital, Roskilde, Patient, Tablet, US Foods, Danish Medicines Agency, FDA, HS, A/S, Quality of life, Life, UNION, Fast Track, Pharmaceutical industry, Management, Doctor of Philosophy

A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for rolling review and priority review.

Key Points: 
  • A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for rolling review and priority review.
  • In the coming interactions with FDA, UNION plans to discuss the most appropriate endpoints, target disease severity, and next steps in the clinical development of oral orismilast for the treatment of HS.
  • It is encouraging to see that FDA recognizes the potential of oral orismilast in hidradenitis suppurativa and grants it fast track designation."
  • Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
    "We are very pleased to receive this Fast Track designation for oral orismilast in hidradenitis suppurativa (HS) and look forward to working closely with the FDA in the design of the clinical development program for oral orismilast.

UNION therapeutics receives FDA Fast Track designation for oral orismilast for the treatment of moderate to severe hidradenitis suppurativa

Retrieved on: 
화요일, 1월 10, 2023
Hidradenitis suppurativa, Dermatology, Food, MD, Infection, OSIRIS, Ethics, Zealand University Hospital, Roskilde, Patient, Tablet, US Foods, Danish Medicines Agency, FDA, HS, A/S, Quality of life, Life, UNION, Fast Track, Pharmaceutical industry, Management, Doctor of Philosophy

A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for rolling review and priority review.

Key Points: 
  • A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for rolling review and priority review.
  • In the coming interactions with FDA, UNION plans to discuss the most appropriate endpoints, target disease severity, and next steps in the clinical development of oral orismilast for the treatment of HS.
  • It is encouraging to see that FDA recognizes the potential of oral orismilast in hidradenitis suppurativa and grants it fast track designation."
  • Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
    "We are very pleased to receive this Fast Track designation for oral orismilast in hidradenitis suppurativa (HS) and look forward to working closely with the FDA in the design of the clinical development program for oral orismilast.

Decentralized Trials & Research Alliance (DTRA) Shares Key Findings from Annual Meeting

Retrieved on: 
목요일, 11월 10, 2022
SAN, GLOBE, Priority, Data collection, DTRA, DCTS, Mission, CVS, Annual, Method, DCT, Data technology, Danish Medicines Agency, Annual general meeting, Ministry, Proceedings of the Human Factors and Ergonomics Society Annual Meeting, Research, Education, Adoption, Ministry of Health (Israel), BMS, Evidence, Alaska Federal Health Care Access Network, Cros, EMA, Publication, Entrepreneurship, Decentralized Trials & Research Alliance, Sanofi, Industry, FDA, Pharmaceutical industry, Renewable energy, Risk management, Parexel

SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a non-profit organization dedicated to the global adoption of decentralized clinical trials and research within life sciences and healthcare, today announced several key initiative updates that will continue to progress throughout 2023. Specialized DTRA teams presented these initiatives during its 2nd Annual Meeting in Boston, MA, from November 6-9, 2022. The meeting was attended by select professionals from its global membership of leaders in decentralized clinical trials (DCTs) including regulators, pharmaceutical and biotechnology sponsors, contract research organizations (CROs) and other service providers, technology companies, research sites, and advocacy leaders.

Key Points: 
  • SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a non-profit organization dedicated to the global adoption of decentralized clinical trials and research within life sciences and healthcare, today announced several key initiative updates that will continue to progress throughout 2023.
  • Specialized DTRA teams presented these initiatives during its 2nd Annual Meeting in Boston, MA, from November 6-9, 2022.
  • The Decentralized Trials & Research Alliance ( DTRA ), a non-profit organization, was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.
  • It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.

Parexel Expands Network of Global Regulatory Experts

Retrieved on: 
목요일, 9월 8, 2022
Danish, Enzyme, EMA, BLA, NDA, Division, National Clinical Assessment Service, AEMPS, Regulation, Degenerative disease, Master of Science, Food and Drug Administration, Hematology, GSK, Heart, Policy, Food, LinkedIn, CMC, Hormone, Cytokine, ANDA, Access, GLOBE, HPRA, Instagram, Committee, FDA, CHMP, Compliance, Twitter, Abbreviated New Drug Application, Efficiency, Science, Safety, Danish Medicines Agency, Drug development, Industry, Health, New Drug Application, Patient, CRO, Pharmaceutical industry, Medical device, Vaccine, EU, Parexel

Parexel has proven to be a reliable and effective regulatory partner in helping our enterprise and biotech customers address ever-evolving regulatory changes and compete on a global scale, said Paul Bridges, Executive Vice President, Regulatory & Access, Parexel.

Key Points: 
  • Parexel has proven to be a reliable and effective regulatory partner in helping our enterprise and biotech customers address ever-evolving regulatory changes and compete on a global scale, said Paul Bridges, Executive Vice President, Regulatory & Access, Parexel.
  • The new leaders join Parexels more than 1,000 seasoned experts whose combined knowledge, skill and experience in quality and compliance expertly guide customers through complex global and in-country regulations.
  • They will provide their insight and expertise on key aspects of the regulatory process, including navigating rapidly evolving landscapes related to regulatory meetings and submissions, compliance and market access.
  • Our new regulatory experts bring significant tenure with global health authorities along with a breadth of therapeutic expertise from rare disease to oncology and hematology and including complex modalities such as cell and gene therapy and monoclonal antibodies to leverage this innovation and navigate global regulatory processes to bring new therapies to patients faster.

Bavarian Nordic Receives U.S. and EU Approvals of its Fill and Finish Vaccine Manufacturing Facility

Retrieved on: 
수요일, 7월 27, 2022
PAI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Rabies, Committee, Food, Johnson & Johnson, Danish Medicines Agency, Janssen Pharmaceuticals, Tick-borne encephalitis, CEO, Danish, Bavarian Nordic, EMA, European Directive on Traditional Herbal Medicinal Products, Government, Monkeypox, Immune system, COVID-19, Public health, OMX, Achievement, Review, European Medicines Agency, CHMP, FDA, Company, Committee for Medicinal Products for Human Use, Smallpox, WHO, Vaccine, Pharmaceutical industry, EU

An expedited pre-approval inspection (PAI) was conducted by the U.S. Food and Drug Administration (FDA) at the facility at the beginning of July 2022.

Key Points: 
  • An expedited pre-approval inspection (PAI) was conducted by the U.S. Food and Drug Administration (FDA) at the facility at the beginning of July 2022.
  • The inspection included the final drug production of JYNNEOS, which was previously performed at a contract manufacturer.
  • The inspection was successfully completed with no observations made, which has led to the approval of Bavarian Nordic as the new drug product manufacturer of JYNNEOS.
  • Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines.

Cultivation License Secured for TGOD's Operations in Denmark

Retrieved on: 
화요일, 1월 29, 2019
Drug control law, Danish Medicines Agency, Legality of cannabis

After the cultivation and harvest of three confirmed and consistent crops, an additional authorization licence will be issued allowing for the sale of authorized medicinal cannabis products.

Key Points: 
  • After the cultivation and harvest of three confirmed and consistent crops, an additional authorization licence will be issued allowing for the sale of authorized medicinal cannabis products.
  • "We are incredibly pleased with the quick receipt of this license from the Danish Medicines Agency," commented Frands Jepsen, Knud Jepsen's CEO.
  • "The initial licence was received promptly after the submission, and the Danish Medicines Agency provided great transparency during the process.
  • Through 80 years of trusted operations in Denmark, we've built excellent relationships with all parties involved and plan to work closely with the Development Scheme."

Cultivation License Secured for TGOD's Operations in Denmark

Retrieved on: 
화요일, 1월 29, 2019
Drug control law, Danish Medicines Agency, Legality of cannabis

After the cultivation and harvest of three confirmed and consistent crops, an additional authorization licence will be issued allowing for the sale of authorized medicinal cannabis products.

Key Points: 
  • After the cultivation and harvest of three confirmed and consistent crops, an additional authorization licence will be issued allowing for the sale of authorized medicinal cannabis products.
  • "We are incredibly pleased with the quick receipt of this license from the Danish Medicines Agency," commented Frands Jepsen, Knud Jepsen's CEO.
  • "The initial licence was received promptly after the submission, and the Danish Medicines Agency provided great transparency during the process.
  • Through 80 years of trusted operations in Denmark, we've built excellent relationships with all parties involved and plan to work closely with the Development Scheme."