PMDA

VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally

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Monday, August 7, 2023
Vitae, Investigational device exemption, Hangzhou, Marketing, Adrenal insufficiency, COVID-19, Clinical trial, Multimedia, Medical Device Regulation Act, RVOT, MDR, PMA, Hospital, Patient, Collection, PMDA, TAVR, United Kingdom, Entrepreneurship, Mortality, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Medical device, Medical imaging

VenusP-Valve, thus, has become the first China-developed heart valvular system to be approved by the FDA for clinical trial, setting a new milestone in the global footprint of Chinese valves.

Key Points: 
  • VenusP-Valve, thus, has become the first China-developed heart valvular system to be approved by the FDA for clinical trial, setting a new milestone in the global footprint of Chinese valves.
  • IDE refers to the exemption of medical devices intended for marketing from regulatory requirements, allowing clinical trials to be conducted on such devices.
  • The announced IDE approval will allow VenusP-Valve to initiate pivotal clinical trials in the U.S. to support the Pre-Market Approval (PMA).
  • As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value.

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

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Friday, August 4, 2023
Science, Software, Biotechnology, Research, Pharmaceutical, Health, Technology, Clinical Trials, Clinical Data Interchange Standards Consortium, Medicines and Healthcare products Regulatory Agency, Adam, Korea Institute of Science and Technology, SDTM, Toxicity, KIT, Data analysis, PMDA, Drug discovery, Toxicology, CORA dataset, SEND, R, CDISC, FDA, NMPA, Exploration, Medical device, Online shopping, Certara

Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .

Key Points: 
  • Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .
  • The combination of Pinnacle 21 Enterprise and SEND Explorer enables synergy for meeting global regulatory guidelines and delivering efficiency.
  • SEND Explorer is a validated, web-based application that provides advanced viewing, data summarization and visualization capabilities for nonclinical study data.
  • Using SEND Explorer, scientists generate visualizations of single and multiple toxicology studies to inform decisions and quickly address questions from health authorities.

iRhythm Technologies Announces Second Quarter 2023 Financial Results

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Thursday, August 3, 2023
MHLW, Medicines and Healthcare products Regulatory Agency, Ministry of Health, Labour and Welfare, European Society of Cardiology, Medication, Pharmaceuticals and Medical Devices Agency, IRTC, Congress, EBITDA, Traction, Patient, PMDA, SAN, Growth, ESC, Payment card, Pharmaceutical industry, Video game, Health, Labour, Georgy Shonin

SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three and six months ended June 30, 2023.

Key Points: 
  • SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three and six months ended June 30, 2023.
  • Revenue for the second quarter of 2023 was $124.1 million, up 21.6% from $102.1 million during the same period in 2022.
  • Operating expenses for the second quarter of 2023 were $105.1 million, compared to $93.7 million for the same period in 2022.
  • Adjusted operating expenses for the second quarter of 2023 were $99.7 million, compared to $93.5 million during the same period in 2022.

REALM IDx Announces National Health Coverage of GenMineTOP™ Cancer Genome Profiling System in Japan

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Tuesday, August 1, 2023
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Tao, DNA, Chiyoda, Tokyo, NCC, Young adult, University, International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Pathology, Cancer, Ministry of Health, Labour and Welfare, AYA, Intelligence, Genomics, RNA, Radiology, Doctor of Philosophy, Patient, PMDA, System, Diagnosis, Ministry of Health, Gene, Pharmaceutical industry, Medical imaging, IDX

REALM IDx, Inc. , a health care company pioneering the field of integrated diagnostics, announced today that GenMineTOP Cancer Genome Profiling System (“the System”) has been awarded national health coverage in Japan and will begin full commercial launch of contract testing with strategic partner, LSI Medicine Corporation (Chiyoda-ku, Tokyo; hereinafter “LSIM”).

Key Points: 
  • REALM IDx, Inc. , a health care company pioneering the field of integrated diagnostics, announced today that GenMineTOP Cancer Genome Profiling System (“the System”) has been awarded national health coverage in Japan and will begin full commercial launch of contract testing with strategic partner, LSI Medicine Corporation (Chiyoda-ku, Tokyo; hereinafter “LSIM”).
  • Japan’s Ministry of Health, Labour and Welfare approved use of the System for the diagnosis of solid tumor patients and to aid in determining the course of treatment.
  • “Our collaboration brought together the best of academia and industry, and will have a tremendous impact on empowering clinical decision-making and improving patient outcomes.
  • “GenMineTOP cancer genome profiling system is an important addition to the REALM Pharma Services offering and further strengthens our work in integrated diagnostics,” said Aaron Elliott, PhD, Chief Executive Officer of REALM IDx.

CDISC Selects Myota to Protect IP Against Ransomware Attacks

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Friday, July 21, 2023
FDA, Security, Data Management, Other Health, Technology, Pharmaceutical, Oncology, General Health, Medical Devices, Infectious Diseases, Clinical Trials, Biotechnology, Science, Software, Other Science, Health, Volunteering, Medicines and Healthcare products Regulatory Agency, Global health, Multimedia, Research, IP, Organization, Disaster, PMDA, National Medical Products Administration, CDISC, NMPA, Corruption, Online shopping, Risk management, Computer data storage, Dracaenura myota

CDISC has selected Myota's bucketZero solution to bolster their IP protection capabilities.

Key Points: 
  • CDISC has selected Myota's bucketZero solution to bolster their IP protection capabilities.
  • "With Myota bucketZero, CDISC gains an unparalleled defense against evolving data threats.
  • About CDISC: CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality.
  • About Myota: Myota is a leading provider of advanced data protection platforms, offering comprehensive solutions that ensure data durability, availability, security, and compliance.

KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results

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Friday, July 7, 2023
Biotechnology, Diabetes, Health, Pharmaceutical, Clinical Trials, Attack, International Society of Sculptors, Painters and Gravers, Hereditary angioedema, Clinical trial, NDA, ODT, EAACI, G&A, Research, European Academy of Allergy and Clinical Immunology, Angioedema, ISTH, Thrombosis, Public expenditure, Congress, HAE, Patient, PMDA, Mouse, KALV, FDA, Safety, D, Pharmaceutical industry, Lancet

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2023.

Key Points: 
  • KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2023.
  • “We have made a great deal of progress over the last fiscal year in the development of sebetralstat,” said Andrew Crockett, Chief Executive Officer of KalVista.
  • Research and development expenses were $80.3 million for the fiscal year ended April 30, 2023, compared to $70.2 million for the prior fiscal year.
  • General and administrative expenses were $30.6 million for the fiscal year ended April 30, 2023, compared to $26.4 million for the prior fiscal year.

GenScript Doubles cGMP sgRNA and Non-Viral DNA Payload Manufacturing Capacity

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Thursday, July 6, 2023
GMP, DNA, CRISPR, Facility, File, GenScript Biotech, HDR, Doctor of Philosophy, EMA, HS, Documentation, CGMP, MD, UCSF, Patient, PMDA, Growth, FDA, MRNA vaccine, IND, NMPA, Vaccine, Fine chemical

PISCATAWAY, N.J., July 6, 2023 /PRNewswire/ -- GenScript Biotech Corporation, the world's leading provider of life-science research tools and services, has expanded its cGMP manufacturing capacity for sgRNA and non-viral DNA payloads with a new, state-of-the-art facility in Zhenjiang, Jiangsu, China. This latest expansion provides biopharma companies and gene and cell therapeutic discovery startups a fast-turnaround source of the quality components needed to advance novel therapies from the bench to the clinic and onto the market in less time.

Key Points: 
  • at GenScript's cGMP facility in Zhenjiang, China gives biopharma companies and gene/cell therapeutic discovery startups fast access to synthetic CRISPR sgRNA and non-viral single and double-stranded DNA payloads
    PISCATAWAY, N.J., July 6, 2023 /PRNewswire/ -- GenScript Biotech Corporation , the world's leading provider of life-science research tools and services, has expanded its cGMP manufacturing capacity for sgRNA and non-viral DNA payloads with a new, state-of-the-art facility in Zhenjiang, Jiangsu, China .
  • ft. cGMP plant in Nanjing, comprising five cGMP production lines for synthetic CRISPR sgRNA and non-viral DNA payloads.
  • "GenScript is pleased to complete the expansion of our manufacturing capacity of cGMP sgRNA and non-viral DNA payloads for IND filing and clinical trials," said Ray Chen, president of the Life Science Group at GenScript.
  • The opening of our newest cGMP manufacturing facility represents our strong commitment to supporting our gene and cell therapy customers."

BioCardia Completes Submission of CardiAMP Cell Therapy System in Heart Failure to Japan’s Pharmaceutical Medical Device Agency

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Wednesday, July 5, 2023
Therapy, BCDA, Principal investigator, Pharmaceuticals and Medical Devices Agency, Cell, Regenerative medicine, Patient, PMDA, European, Heart failure, Heart, Safety, Pharmaceutical industry

SUNNYVALE, Calif. , July 05, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it completed its submission of the CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF).

Key Points: 
  • SUNNYVALE, Calif. , July 05, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it completed its submission of the CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF).
  • The formal consultation with PMDA to review the submission is anticipated in approximately three months and will be BioCardia’s third consultation with PMDA.
  • “We believe there is high potential for approval of the CardiAMP Cell Therapy for Heart Failure in Japan based on the existing safety and efficacy data, the CardiAMP cell processing platform’s existing approval in Japan for other therapeutic indications, the CardiAMP minimally invasive delivery system which does not require open chest surgical access to enable implantation of cells, and the Japanese leadership scientifically and clinically in cardiovascular regenerative medicine therapies.
  • It may also help that our proprietary delivery system is approved in the European Union for the same indication and is expected to have utility for other therapies being advanced in Japan,” said Peter Altman, President and CEO.

Cosmo announces Cortiment® approval in Japan

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Wednesday, June 28, 2023
Budesonide, Ferring Pharmaceuticals, Bleeding, Prevalence, IBD, Medicines and Healthcare products Regulatory Agency, Bausch, Weight loss, Quality of life, XETRA, Cramp, Inflammation, Diarrhea, Colon, Tablet, Inflammatory bowel disease, Defecation, C43, UC, Cosmo, Ulcerative colitis, PMDA, MMX, Bloating, Ulcer, Fatigue, Pharmaceutical industry

Dublin, Ireland – 28 June 2023: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) today announced that its partner Ferring Pharmaceuticals (“Ferring”) has received the approval for Cortiment® (budesonide 9 mg MMX tablets) in Japan by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

Key Points: 
  • Dublin, Ireland – 28 June 2023: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) today announced that its partner Ferring Pharmaceuticals (“Ferring”) has received the approval for Cortiment® (budesonide 9 mg MMX tablets) in Japan by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
  • First sales of Cortiment® in Japan are expected to begin by end of Q3 2023.
  • Cortiment® has been developed by Cosmo and is globally distributed by Ferring, with the exception of the US, where it is distributed by Bausch.
  • Alessandro Della Chà, CEO of Cosmo Pharmaceuticals, comments: “We are very pleased with the new success our partner Ferring Pharmaceuticals has achieved with Cortiment®.

CXR-AID, Powered by Lunit, Nets Japan Nod for Reimbursement, Accelerating Market Expansion Opportunities

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Monday, June 26, 2023
JRS, Partnership, MHLW, Policy, Medicines and Healthcare products Regulatory Agency, Lung cancer, Government, Fujifilm, Hospital, Guideline, Patient, PMDA, Algorithm, Growth, AI, CXR, Hospital Insurance and Diagnostic Services Act, Diagnosis, Medical device, Medical imaging, Welfare, Health

SEOUL, South Korea, June 26, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a global provider of cancer diagnostics solutions, today announced that CXR-AID, FujiFilm's AI solution for chest X-ray analysis, powered by Lunit INSIGHT CXR, has been officially included as an eligible solution for health insurance reimbursement in Japan.

Key Points: 
  • MHLW added the new Class 3 condition for hospitals utilizing AI image diagnostics software and fulfilling specific facility and safety criteria.
  • This significantly boosts Lunit and FujiFilm's expansion in the Japanese market and creates new growth prospects in the field of AI image diagnostics.
  • Its exceptional diagnostic performance led to the approval of the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in 2021.
  • The market expansion of CXR-AID in Japan is further bolstered by FujiFilm's widespread presence, with its screening devices and solutions already being utilized by over 25,000 medical institutions nationwide.