MHLW

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

Retrieved on: 
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.

Shionogi Enrolls the First Participant in Japan in its Global Phase 3 Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Retrieved on: 
Friday, June 9, 2023
Science, Research, General Health, Health, FDA, COVID-19, Infectious Diseases, Clinical Trials, Infection, Therapy, MHLW, SARS-CoV-2, Head, Public, Respiratory disease, Ministry of Health, Labour and Welfare, Fast Track, Ministry, Ensitrelvir, Patient, Ministry of Health (British Columbia), Generic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Shionogi

The study will evaluate the safety and efficacy of the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • The study will evaluate the safety and efficacy of the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • : S-217622, hereafter “ensitrelvir”) for the prevention of symptomatic SARS-CoV-2 infection in study participants exposed to household contacts who are symptomatic and tested positive for SARS-CoV-2, when compared to placebo.
  • In addition, Shionogi also announced that it has filed for full approval of ensitrelvir in Japan.
  • Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.

Astellas Submits New Drug Application for Zolbetuximab in Japan

Retrieved on: 
Friday, June 9, 2023
Dicarboxylic acid, Adenocarcinoma, Doctor of Public Health, Capecitabine, MHLW, Neoplasm, Oxaliplatin, NDA, Cancer, Ministry of Health, Labour and Welfare, MBA, Zolbetuximab, MS, CAPOX, Ministry, Death, Patient, GEJ, Immunohistochemistry, Stomach cancer, Fluorouracil, Ministry of Health, Stomach, GLOW, CLDN18, TSE, Pharmaceutical industry, Astellas Pharma, Health

TOKYO, June 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.

Key Points: 
  • If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.
  • "Astellas' submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan."
  • The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.
  • The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

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.

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, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, BIIB, Ministry of Health, Labour and Welfare, Brain, Pharmaceuticals and Medical Devices Agency, Medication, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, The Different Forms of Flowers on Plants of the Same Species, Eisai, Prescription Drug User Fee Act, Headquarters, PMDA, National Medical Products Administration, Corporation, 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, 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.

Krystal Biotech Announces First Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Monday, May 8, 2023
NCT, Netherton syndrome, Cohort, European Medicines Agency, Ministry of Health, Labour and Welfare, Cystic fibrosis, Phase 1, Investment, Patient, Cystic Fibrosis Foundation, TGM1, Ministry of Health (Saudi Arabia), Association for Research in Vision and Ophthalmology, ARVO, Prescription Drug User Fee Act, Pannus, AATD, Rare, Jeune, FDA, IND, Skin, Safety, PIP, RDEB, Eye, Ministry, Financial result, Form, Research, Therapy, KRYS, DEB, MHLW, Clinical trial, Marketing, Annual general meeting, Pharmaceutical industry, Maple syrup, Ophthalmology, PDUFA, Health

Financial results for the quarter ended March 31, 2023:

Key Points: 
  • Financial results for the quarter ended March 31, 2023:
    Cash, cash equivalents, and investments totaled $355.5 million on March 31, 2023.
  • Research and development expenses for the quarter ended March 31, 2023 were $12.3 million, compared to $9.3 million for the quarter ended March 31, 2022.
  • General and administrative expenses for the quarter ended March 31, 2023 were $24.0 million, compared to $15.9 million for the quarter ended March 31, 2022.
  • For additional information on the Company’s financial results for the quarter ended March 31, 2023, please refer to the Form 10-Q filed with the SEC.

Global and Regional Surgical Robotics Market Analysis and Forecasts, 2022-2023 & 2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, April 28, 2023
Technology, Robotics, Health, Surgery, Partnership, RA, Bed, MHLW, Ion, COVID-19, Cancer, Ministry of Health, Labour and Welfare, Curie Institute (Paris), Trial of the century, Ministry, Hospital, Patient, Johnson & Johnson, Microsurgery, Artificial intelligence, DePuy Synthes, Growth, Region, FDA, Ministry of Health, Intuitive Surgical, CMR Surgical, Safety, Country, Medical device, Pharmaceutical industry

The "Surgical Robotics Market - A Global and Regional Analysis: Focus on Type, Application, End-user, and Country - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Surgical Robotics Market - A Global and Regional Analysis: Focus on Type, Application, End-user, and Country - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.
  • The increasing demand for minimally invasive surgeries, increasing demand for robotic-assisted surgeries, and increasing synergetic activities within the surgical robotics industry are some of the major opportunities in the global surgical robotics market.
  • The COVID-19 pandemic has impacted practically all sectors and social functions worldwide, including the global surgical robotics market.
  • The global surgical robotics market based on the end-user segment is dominated by the hospitals segment.

ECCMID 2023: Shionogi to Present Data Showing COVID-19 Symptom Recurrence is Not Associated with Ensitrelvir Treatment

Retrieved on: 
Tuesday, April 4, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, MHLW, SARS-CoV-2, Head, Ministry of Health, Labour and Welfare, Fast Track, Infection, RNA, Ministry, Ensitrelvir, Congress, ECCMID, Patient, European, Ministry of Health (Saudi Arabia), FDA, Recurrence, Generic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PCR, Food, Pharmaceutical industry, Vaccine, Shionogi

: S-217622, hereafter “ensitrelvir”) will be published as posters at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark 15 - 18 April 2023.

Key Points: 
  • : S-217622, hereafter “ensitrelvir”) will be published as posters at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark 15 - 18 April 2023.
  • Ensitrelvir, known as Xocova® 125 mg tablet in Japan, received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of SARS-CoV-2 infection.
  • The first late-breaking poster presentation included a post-hoc analysis of the Phase 3 part showing that viral rebound and symptom recurrence were infrequently seen up to 21 days after treatment with ensitrelvir.
  • Symptom recurrence was rare and was not associated with viral RNA rebound.

Shionogi Receives U.S. FDA Fast Track Designation for Ensitrelvir Fumaric Acid, an Investigational Oral Antiviral for COVID-19

Retrieved on: 
Tuesday, April 4, 2023
Health, FDA, Infectious Diseases, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Therapy, MHLW, SARS-CoV-2, Head, Infection, Ministry of Health, Labour and Welfare, Fast Track, Research, Fungal infection, Medicines Patent Pool, Ministry, Ensitrelvir, CROI, Patient, Ministry of Health (Saudi Arabia), Developing country, Diagnosis, United, Generic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Food, Safety, Pharmaceutical industry, Shionogi

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need.
  • Receiving Fast Track designation from the FDA recognizes the potential of ensitrelvir as a once-daily, oral antiviral for SARS-CoV-2,” said Nathan McCutcheon, CEO, Shionogi Inc., the U.S. subsidiary of Shionogi.
  • Several additional Phase 3 clinical studies evaluating the safety and efficacy of ensitrelvir across a wide range of COVID-19 patient populations are planned and ongoing.

Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published

Retrieved on: 
Tuesday, April 4, 2023
Priority review, Plaque, CET, MHLW, Marketing, Advisory Committee, Memantine, Food, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Clinical trial, Quality of life, Ministry of Health, Labour and Welfare, Brain, Alzheimer's disease, SOC, MCI, Medication, Pharmaceuticals and Medical Devices Agency, Advisory Committee on Immunization Practices, EMA, Clarity, Ministry, Eisai, Prescription Drug User Fee Act, HIV disease progression rates, Patient, Standard of care, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), Neurology, MAA, AD, FDA, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Caregiver, Safety, Pharmaceutical industry, Biogen, Health

A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.

Key Points: 
  • A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
  • This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
  • The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
  • The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.