Medicines and Healthcare products Regulatory Agency

Trajan's Microsampling Devices Meet IVDR Compliance in Europe, UK

Retrieved on: 
Friday, June 2, 2023
Medicine, IVDR, Health, Mitra, Medication, Research, DBS, MHRA, Medicines and Healthcare products Regulatory Agency, Safety, Medical device, Trajan

MELBOURNE, Australia, June 2, 2023 /PRNewswire/ -- Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, today announced the regulatory approval of its Neoteryx remote blood microsampling devices, Mitra® and hemaPEN® for clinical use in Europe and the United Kingdom.

Key Points: 
  • Trajan has successfully fulfilled the required product safety and performance requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
  • Having earned this CE Mark regulatory compliance, Trajan expands the capabilities of its Neoteryx® microsampling products to provide decentralised, person-centered, minimally invasive blood collection in both clinical and research settings.
  • Mitra® and hemaPEN® devices can be used remotely to collect blood samples through an easy, virtually painless process.
  • "The updated regulatory approval of Trajan's blood microsampling devices in the UK and European Union is another step forward towards our vision of personalized, preventative data-based healthcare," said Stephen Tomisich, CEO and founder of Trajan.

Trajan's Microsampling Devices Meet IVDR Compliance in Europe, UK

Retrieved on: 
Friday, June 2, 2023
Medicine, IVDR, Health, Mitra, Medication, Research, DBS, MHRA, Medicines and Healthcare products Regulatory Agency, Safety, Medical device, Trajan

MELBOURNE, Australia, June 2, 2023 /PRNewswire/ -- Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, today announced the regulatory approval of its Neoteryx remote blood microsampling devices, Mitra® and hemaPEN® for clinical use in Europe and the United Kingdom.

Key Points: 
  • Trajan has successfully fulfilled the required product safety and performance requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
  • Having earned this CE Mark regulatory compliance, Trajan expands the capabilities of its Neoteryx® microsampling products to provide decentralised, person-centered, minimally invasive blood collection in both clinical and research settings.
  • Mitra® and hemaPEN® devices can be used remotely to collect blood samples through an easy, virtually painless process.
  • "The updated regulatory approval of Trajan's blood microsampling devices in the UK and European Union is another step forward towards our vision of personalized, preventative data-based healthcare," said Stephen Tomisich, CEO and founder of Trajan.

Freeline Reports First Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Tuesday, May 30, 2023
Gaucher's disease, CMC, American depositary receipt, Sale, Parini, Daimler Freeline, Patient, Cell, Medicines and Healthcare products Regulatory Agency, Innovation, Safety, MHRA, Dedicated, Pharmaceutical industry, Gaucher, Brammer

LONDON, May 30, 2023 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today reported financial results for the first quarter of 2023 and provided a business update.

Key Points: 
  • LONDON, May 30, 2023 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today reported financial results for the first quarter of 2023 and provided a business update.
  • “The granting of the ILAP designation by UK regulators further highlights the significant need for more effective and less burdensome therapies for people with Gaucher disease.
  • “Importantly, we continue to make significant strides as a company in driving greater focus, financial discipline, and operational efficiency,” Parini continued.
  • Cash position: As of March 31, 2023, unrestricted cash and cash equivalents were $55.4 million, compared to $47.3 million as of December 31, 2022.

FDA Provides Akebia Therapeutics a Path Forward for Vadadustat

Retrieved on: 
Tuesday, May 30, 2023
Mitsubishi Tanabe Pharma, Chronic kidney disease, Civil service commission, Symantec Endpoint Protection, Vadadustat, Rockwell Medical, Health care, Clinical trial, NDA, AKBA, Hepatotoxicity, Gross metropolitan product, Dialysis, European Commission, Division, Patient, European Economic Area, Risk, Anemia, OND, Medicines and Healthcare products Regulatory Agency, United Kingdom, Webcast, CRL, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Complete Response Letter, Food, Kidney disease, Safety, Medical device, Pharmaceutical industry, VAT, Akebia

The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).

Key Points: 
  • The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).
  • Accordingly, Akebia plans to include post-approval data from Japan in the NDA resubmission, where tens of thousands of Japanese patients with CKD have been exposed to vadadustat to date.
  • The OND's letter provides guidance on a path for the resubmission of our NDA and potential approval of vadadustat for dialysis dependent patients in the U.S. without suggesting the need to generate additional clinical data.
  • We appreciate the FDA's engagement with us throughout the appeal process," said John P. Butler, Chief Executive Officer of Akebia.

CELL WORLD - Aiming at Internationalization, Starting from Regulation - The 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration Successfully Held

Retrieved on: 
Monday, May 29, 2023
Laughter, European Medicines Agency, Tisagenlecleucel, First Affiliated Hospital of Xinjiang Medical University, Soochow University, Patient, Shanghai University, Cell, Medicines and Healthcare products Regulatory Agency, BLA, BioValley, DLBCL, Duke University School of Medicine, EMA, CELL, Anniversary Celebration, FDA, IND, Multimedia, China Institute for Innovation and Development Strategy, Therapy, MD Anderson Cancer Center, RMB, MHRA, Speech, CMC, Medication, Bristol Myers Squibb, Implementation, CDMO, Clinical trial, Novartis, IBLA International Competition, DoubleTree, Bengbu Medical College, Pharmaceutical industry, Medical device, EU, Medicine

SUZHOU, China, May 29, 2023 /PRNewswire/ -- On May 26, 2023, the "CELL WORLD 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration," meticulously planned by Hillgene Biopharma and Biovalley, was successfully held at the DoubleTree by Hilton in Wuzhong District, Suzhou.

Key Points: 
  • SUZHOU, China, May 29, 2023 /PRNewswire/ -- On May 26, 2023, the "CELL WORLD 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration," meticulously planned by Hillgene Biopharma and Biovalley, was successfully held at the DoubleTree by Hilton in Wuzhong District, Suzhou.
  • "This is the 1st summit of CELL WORLD, and Hillgene Biopharma will host this summit in the long term.
  • I hope this 1st CELL WORLD Global Cell Therapy Summit will further promote the development and innovation of cell therapy industry globally and provide more thoughts and practical examples."
  • The "CELL WORLD 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration" came to a perfect end amid the laughter and joy of the banquet.

Adverum Biotechnologies Announces New Executive Leadership Roles

Retrieved on: 
Thursday, May 25, 2023
Gilead Sciences, Adverum Biotechnologies, Drug development, AMD, Pharming, Pharmacovigilance, European Medicines Agency, Lead, Novartis Institute for Tropical Diseases, Biomedical Research, LUNA, PRIME, IVT, Patient, Ophthalmology, Johnson & Johnson, United, Medicines and Healthcare products Regulatory Agency, Pharmaceutical industry, Pittosporum tobira

REDWOOD CITY, Calif., May 25, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced new executive leadership roles that support the ongoing development of the investigational gene therapy ixoberogene soroparvovec (Ixo-vec). Ixo-vec is currently being evaluated in the Phase 2 LUNA trial as a one-time intravitreal (IVT) injection for patients in the treatment of neovascular or wet age-related macular degeneration (wet AMD).

Key Points: 
  • Dr. Beckman will continue to advise on Adverum’s pipeline, including Ixo-vec, and support our external engagement with key stakeholders.
  • Star Seyedkazemi, Pharm.D., chief development officer, is expanding her responsibilities to lead Adverum’s clinical development, medical affairs and pharmacovigilance teams.
  • Dr. Beckman and Dr. Seyedkazemi will continue to report to Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • “I am pleased that he will continue to work with Adverum in his role as senior medical advisor.

Tasso Recommended for Certification from Medical Device Single Audit Program (MDSAP)

Retrieved on: 
Thursday, May 18, 2023
Health, FDA, Medical Devices, Hospitals, Manufacturing, Other Manufacturing, Biotechnology, International medical graduate, Patient, CE marking, Medicines and Healthcare products Regulatory Agency, Food and Drug Administration, Therapeutic Goods Administration, Ministry of Health, Labour and Welfare, Doctor of Philosophy, MDSAP, Certification, Organization, Medical device, Health Canada, Food

Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, today announced that it has been recommended for certification from the Medical Device Single Audit Program (MDSAP), under which a single regulatory audit of a medical device manufacturer may satisfy the requirements of multiple regulatory jurisdictions participating in the program.

Key Points: 
  • Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, today announced that it has been recommended for certification from the Medical Device Single Audit Program (MDSAP), under which a single regulatory audit of a medical device manufacturer may satisfy the requirements of multiple regulatory jurisdictions participating in the program.
  • The certification confirms Tasso’s compliance with the standards and regulatory requirements of Australia, Canada and the United States, opening potential new global markets for Tasso.
  • Once received, the certification also can streamline the process of reaching additional markets covered under the MDSAP, including Brazil and Japan.
  • The MDSAP program is part of the International Medical Device Regulators Forum.

Kapruvia® (difelikefalin) recommended by England's NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus

Retrieved on: 
Thursday, May 18, 2023
New England, National Health Service, Barts Health NHS Trust, Chronic kidney disease, Medicine, Health care, Quality of life, Medication, CSL Vifor, Hemodialysis, Medicines and Healthcare products Regulatory Agency, Patient, Itch, Therapy, CKD, NICE, MHRA, National Institute for Health and Care Excellence, Nursing, Pharmaceutical industry

ST. GALLEN, Switzerland and STAMFORD, Conn., May 18, 2023 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that England's National Institute for Health and Care Excellence (NICE) has recommended Kapruvia® for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis. The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022.

Key Points: 
  • The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022.
  • "The recommendation of Kapruvia® by NICE is a key step on our journey to bring this breakthrough treatment to in-centre haemodialysis patients living with moderate-to-severe CKD-associated pruritus in the UK," said Fabio Dorigotti, Head Global Medical Affairs of CSL Vifor.
  • "We look forward to continue working with the National Health Service to ensure access to this important medicine for patients as quickly as possible."
  • "Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus is managed."

Kapruvia® (difelikefalin) recommended by England's NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus

Retrieved on: 
Thursday, May 18, 2023
New England, National Health Service, Barts Health NHS Trust, Chronic kidney disease, Medicine, Health care, Quality of life, Medication, CSL Vifor, Hemodialysis, Medicines and Healthcare products Regulatory Agency, Patient, Itch, Therapy, CKD, NICE, MHRA, National Institute for Health and Care Excellence, Nursing, Pharmaceutical industry

ST. GALLEN, Switzerland and STAMFORD, Conn., May 18, 2023 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that England's National Institute for Health and Care Excellence (NICE) has recommended Kapruvia® for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis. The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022.

Key Points: 
  • The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022.
  • "The recommendation of Kapruvia® by NICE is a key step on our journey to bring this breakthrough treatment to in-centre haemodialysis patients living with moderate-to-severe CKD-associated pruritus in the UK," said Fabio Dorigotti, Head Global Medical Affairs of CSL Vifor.
  • "We look forward to continue working with the National Health Service to ensure access to this important medicine for patients as quickly as possible."
  • "Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus is managed."

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.