Medicines and Healthcare products Regulatory Agency

Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency

Retrieved on: 
Thursday, June 15, 2023
Priority review, CRC, Progression-free survival, Marketing, TAK, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, JAMA, NDA, Prescription Drug User Fee Act, EMA, American Medical Association, VEGF, HKEX, Journal, Patient, Physician, PMDA, PDUFA, BSC, MAA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Takeda

OSAKA, Japan and CAMBRIDGE, Mass. and HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Takeda (TSE:4502/​NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announced that the European Medicines Agency (“EMA”) has validated and accepted for regulatory review the marketing authorization application (“MAA”) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the E.U. for previously treated metastatic CRC.1,2

Key Points: 
  • Placebo plus BSC for Adult Patients with Previously Treated Metastatic Colorectal Cancer —
    OSAKA, Japan and CAMBRIDGE, Mass.
  • If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the E.U.
  • for previously treated metastatic CRC.1,2
    “European patients with metastatic colorectal cancer have not benefitted from a treatment advancement in over a decade,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda.
  • who find treatment options to be limited for previously treated metastatic colorectal cancer,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer, HUTCHMED.

Takeda and HUTCHMED Announce Publication of Phase 3 FRESCO-2 Results in The Lancet

Retrieved on: 
Friday, June 16, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Priority review, CRC, Progression-free survival, TAK, European Medicines Agency, New Drug Application, OS, NDA, Medicines and Healthcare products Regulatory Agency, PFS, Marketing, EMA, Patient, PMDA, VEGFR, BSC, MAA, European Society of Gynaecological Oncology, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCM, Food, Pharmaceutical industry, Takeda, Lancet

Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that results of the Phase 3 FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in The Lancet.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that results of the Phase 3 FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in The Lancet.
  • The publication provides details of the FRESCO-2 study results as of June 24, 2022.
  • Summary results from this cut-off date were presented on September 12, 2022, at the European Society for Medical Oncology Congress 2022 (ESMO22).
  • In March 2023, HUTCHMED and Takeda closed an exclusive license agreement to further the global development, commercialization and manufacture of fruquintinib outside of China.

Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency

Retrieved on: 
Thursday, June 15, 2023
General Health, Health, Pharmaceutical, Clinical Trials, Oncology, Priority review, CRC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Marketing, Progression-free survival, TAK, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, JAMA, NDA, PFS, EMA, American Medical Association, VEGF, HKEX, Journal, Prescription Drug User Fee Act, Patient, Physician, PMDA, VEGFR, European, PDUFA, BSC, MAA, FDA, HCM, Pharmaceutical industry, EU, Takeda

Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (HUTCHMED) today announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (HUTCHMED) today announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).
  • “We are thrilled to have submitted the marketing authorization application to the EMA, bringing us one step closer to potentially offering this innovative therapy to patients with advanced disease.
  • FRESCO-2 is a global Phase 3 multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with previously treated metastatic CRC.
  • Submission of an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) is also planned in 2023.

Vial Partners with Nielsen BioSciences, Inc. in Phase III Clinical Trial for the Treatment of Common Warts

Retrieved on: 
Wednesday, June 14, 2023
Wuhan Institute of Biological Products, Infection, Vial, Clinical data management, Wart, Medicines and Healthcare products Regulatory Agency, Dermatology, Clinical trial, Finger, MBA, Common, Digital technology, Patient, ESourcing Capability Model, SAN, HPV, Viral, Nielsen, FDA, Phase, Skin, Safety, Pharmaceuticals and Medical Devices Agency, EDC, Fine chemical, Vaccine, Pharmaceutical industry, Plantar wart

Vial will support Nielsen with their Phase III, randomized, double-blind, placebo-controlled clinical study of CANDIN for the treatment of Verruca vulgaris (common warts) in adolescents and adults in the U.S. and Japan.

Key Points: 
  • Vial will support Nielsen with their Phase III, randomized, double-blind, placebo-controlled clinical study of CANDIN for the treatment of Verruca vulgaris (common warts) in adolescents and adults in the U.S. and Japan.
  • Vial's Dermatology CRO will work closely with the Nielsen Biosciences team through the completion of the Phase III clinical trial.
  • "Vial is thrilled to collaborate with Nielsen on their Phase III clinical trial in the U.S. and Japan.
  • We look forward to partnering with the Vial team on CANDIN's Phase III clinical trial," said David P. Burney, Ph.D., MBA, President and COO at Nielsen BioSciences.

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.