Ministry of Health, Labour and Welfare

SUSMED’s DTx Approved in Japan for the Treatment of Insomnia

Retrieved on: 
Friday, August 25, 2023

SUSMED, Inc. (TOKYO:4263) announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (the ”MHLW”) of SUSMED Med CBT-i® App for Insomnia (the ”product”). SUSMED is in the process of applying for insurance coverage, and market launch.

Key Points: 

SUSMED, Inc. (TOKYO:4263) announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (the ”MHLW”) of SUSMED Med CBT-i® App for Insomnia (the ”product”). SUSMED is in the process of applying for insurance coverage, and market launch.

Olympus to Launch Development Support Project in Kenya for the Diagnosis of Gastrointestinal Diseases

Retrieved on: 
Thursday, July 20, 2023

from Nairobi Gastroenterology Training Centre, Kenyatta National Hospital said, "There is an increase of cancer cases in Kenya.

Key Points: 
  • from Nairobi Gastroenterology Training Centre, Kenyatta National Hospital said, "There is an increase of cancer cases in Kenya.
  • In Kenya, the proportion of non-communicable diseases as a cause of death has been growing.
  • This will be a combination of on-site training, training in Japan, and online training.
  • Olympus will arrange training courses and the equipment necessary for the training.

iRhythm Technologies Announces Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023

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

Retrieved on: 
Tuesday, August 1, 2023

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.

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

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

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.

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

Retrieved on: 
Thursday, May 18, 2023

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.

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

Retrieved on: 
Tuesday, May 16, 2023

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

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.

Dexcom Showcases Accuracy, Reliability and Ease of Use of Its Dexcom G6 CGM System at the 66th Annual Meeting of the Japan Diabetes Society

Retrieved on: 
Wednesday, May 10, 2023

DexCom, Inc. (NASDAQ: DXCM), a global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, will showcase the accuracy, reliability and ease of use of its Dexcom G6 CGM System and will highlight the latest clinical evidence that continues to demonstrate the effectiveness of Dexcom CGM during the 66th Annual Meeting of the Japan Diabetes Society held May 11-13, 2023 in Kagoshima, Japan.

Key Points: 
  • DexCom, Inc. (NASDAQ: DXCM), a global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, will showcase the accuracy, reliability and ease of use of its Dexcom G6 CGM System and will highlight the latest clinical evidence that continues to demonstrate the effectiveness of Dexcom CGM during the 66th Annual Meeting of the Japan Diabetes Society held May 11-13, 2023 in Kagoshima, Japan.
  • “As the population of Japan continues to age, the incidence rate of diabetes among older adults is also increasing.
  • To learn more about Dexcom CGM and to get started with Dexcom G6, visit Dexcom.com.
  • Terumo Corporation is the official distributor of Dexcom CGM in Japan.