MHLW

Good Design Grand Award 2023 Winners Announced

Retrieved on: 
Thursday, November 9, 2023
Children, Residential Building & Real Estate, Urban Planning, Construction & Property, Landscape, Interior Design, Seniors, Building Systems, Architecture, Consumer, Other Construction & Property, Good Design Awards, JIA, Realization, Ageing, Good, FOR, JDP, Gold, Waseda University, Design, Multimedia, Ministry of Health, Labour and Welfare, Ministry, Trust, Japan Institute of Design Promotion, Happiness, MHLW, If, Integrated care system, Tokyo University of Science, Community, Kogakuin University, Yamazaki, Hosei University, Hospice, ALL, Communication, Film industry, Interior design, Health insurance, Residential care, Nursing, Engawa, Health

The Japan Institute of Design Promotion (JDP : Minato-ku, Tokyo) announced that the Good Design Grand Award for 2023 has been awarded to the “Long house with an engawa”, a Senior Daycare Center.

Key Points: 
  • The Japan Institute of Design Promotion (JDP : Minato-ku, Tokyo) announced that the Good Design Grand Award for 2023 has been awarded to the “Long house with an engawa”, a Senior Daycare Center.
  • View the full release here: https://www.businesswire.com/news/home/20231108326322/en/
    Senior Daycare Center, Long house with an engawa (Photo: Business Wire)
    The Good Design Grand Award is the highest award given to one of the winners of the annual Good Design Awards.
  • Since 1980, the Good Design Grand Award has produced various famous designs as it symbolizes today's society and a suitable symbol of what design can do in the future.
  • “Long house with an engawa” was selected from among 1,548 entries for the Good Design Award 2023 by a vote of the jury members and award winners.

Regeneron Reports Third Quarter 2023 Financial and Operating Results

Retrieved on: 
Thursday, November 2, 2023
CSU, DLBCL, Bispecific monoclonal antibody, FDA, Adolescence, American College, Ageing, CD3, ESMO, Food, Multiple myeloma, CD20, Fast Track, ACG, Congress, European Society for Medical Oncology, DME, Symantec Endpoint Protection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American College of Gastroenterology, The Lancet, Ministry, Ministry of Health (Kuwait), CRL, MHLW, Ministry of Health, Labour and Welfare, Oncology, Sanofi, Safety, Atopic dermatitis, CSCC, European, Patient, BCMA, Chronic obstructive pulmonary disease, COPD, Dupilumab, BLA, Pharmaceutical industry, Medical device, Vaccine, C5, Regeneron Pharmaceuticals, Health, EU

"Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.

Key Points: 
  • "Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.
  • These results were also presented at the 23rd EURETINA Congress in October 2023.
  • The Company announced that Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron, will retire in February 2024.
  • Christopher Fenimore, current Senior Vice President, Head of Accounting and Controller at Regeneron, will succeed Mr. Landry as Chief Financial Officer upon his retirement.

Pulmonx Reports Record Third Quarter 2023 Financial Results

Retrieved on: 
Monday, October 30, 2023
Tax, International, EBITDA, GAAP, Bank statement, Growth, MHLW, Traction, Depreciation, Table, Investment, Patient, Video game, Cryptocurrency, Bank, Health

REDWOOD CITY, Calif., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx” or the "Company"), a global leader in minimally invasive treatments for lung disease, today reported financial results for the third quarter of 2023 ended September 30, 2023.

Key Points: 
  • REDWOOD CITY, Calif., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx” or the "Company"), a global leader in minimally invasive treatments for lung disease, today reported financial results for the third quarter of 2023 ended September 30, 2023.
  • Gross profit in the third quarter of 2023 was $13.0 million, compared to $10.2 million for the third quarter of 2022.
  • Gross margin for the third quarter of 2023 was 74%, compared to 75% for the same period in 2022, reflecting higher inventory reserves in the quarter.
  • Operating expenses in the third quarter of 2023 were $28.2 million, compared to $24.1 million for the third quarter of 2022, representing an increase of 17%.

Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea

Retrieved on: 
Wednesday, November 1, 2023
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Grand duchy, Food, Face, VWS, Disease, Gonorrhea, MHLW, Partnership, The Lancet, National Rural Development Partnership, Infection, Nursing care plan, Reproduction, SAMRC, Azithromycin, Hope, Physician, Prevalence, HIV, Ceftriaxone, BMBF, Neisseria gonorrhoeae, University, Therapy, Patient, Food and Drug Administration, Infertility, DFID, Heart, BMG, NIAID, MD, DHSC, AMR, BZ, Clinical trial, World Health Organization, Zoliflodacin, Woman, Multidrug-resistant bacteria, FOPH, South African Medical Research Council, Death, Ministry, Pharmaceutical industry, Vaccine, Medicine

These positive preliminary findings offer hope for patients with this condition, particularly in the face of rising antibiotic resistance to current regimens.

Key Points: 
  • These positive preliminary findings offer hope for patients with this condition, particularly in the face of rising antibiotic resistance to current regimens.
  • It also paves the way for a new research and development model in the global fight against antimicrobial resistance (AMR).
  • Now, the positive results of this landmark Phase 3 trial confirm that zoliflodacin has the potential to tackle the most difficult-to-treat gonorrhea infections.
  • This builds on the critical Phase 2 clinical trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

Shionogi Presents New Ensitrelvir COVID-19 Data Supporting Effectiveness in Real-World and Clinical Settings at IDWeek 2023

Retrieved on: 
Wednesday, October 11, 2023
COVID-19, Research, Infectious Diseases, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Senior, Food, Sense, Ensitrelvir, Inc., Taste, Safety, Dysgeusia, MHLW, Drug development, Ministry of Health, Labour and Welfare, Ministry, Head, Fever, Fast Track, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Shionogi, Patient, Risk, Pharmaceutical industry

Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will present new real-world and clinical data at IDWeek 2023 reinforcing the potential of ensitrelvir, its investigational oral antiviral, to treat the symptoms of COVID-19.

Key Points: 
  • Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will present new real-world and clinical data at IDWeek 2023 reinforcing the potential of ensitrelvir, its investigational oral antiviral, to treat the symptoms of COVID-19.
  • Shionogi will present new data evaluating the effectiveness and tolerability of ensitrelvir in clinical practice in Japan.
  • Following emergency regulatory approval from the MHLW in Japan, an ongoing post-marketing surveillance study is enrolling 3,000 Japanese patients.
  • As of July 20, 2023, a total of 1,682 patients were enrolled, of which, 1,589 were evaluated for safety and 1,584 for effectiveness.

Tenapanor for Hyperphosphatemia Approved in Japan

Retrieved on: 
Monday, September 25, 2023
Chronic kidney disease, MHLW, Serum, New Drug Application, NDA, Kyowa Kirin, Dialysis, Patient, Nephrology, Hyperphosphatemia, FDA, Phosphorus, CKD, Safety, TSE, Pharmaceutical industry, Health

WALTHAM, Mass., Sept. 25, 2023 (GLOBE NEWSWIRE) --  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the New Drug Application (NDA) for tenapanor for the improvement of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis. Tenapanor will be marketed with the brand name PHOZEVEL® in Japan.

Key Points: 
  • “The approval of tenapanor for hyperphosphatemia in Japan is a historic moment for Ardelyx and CKD patients on dialysis.
  • The NDA in Japan was supported by data from four Phase 3 clinical trials, conducted in Japan by Kyowa Kirin in patients with hyperphosphatemia on maintenance dialysis.
  • The results of the studies undertaken by Kyowa Kirin suggested that tenapanor may also reduce the medication burden of phosphorus management utilizing marketed phosphate binders in combination with tenapanor or tenapanor alone for treating hyperphosphatemia.
  • In these studies, the safety and tolerability profile for tenapanor was consistent with prior studies in Japan.

Press Release: Once-weekly ALTUVIIIO® approved in Japan as a new class of factor VIII therapy for hemophilia A

Retrieved on: 
Monday, September 25, 2023
US Foods, Bleeding, MHLW, Factor VIII, European Medicines Agency, ABR, Quality of life, Haemophilia, Fast Track, Coordinated Specialty Care, Arthralgia, European Commission, Marketing, Breakthrough therapy, Orphan drug, Patient, Physician, Risk, VIII, Sanofi, Joint, MAA, FDA, Haemophilia A, Chronic pain, Headache, Food, Birth control, Pharmaceutical industry, Welfare, Health

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO®[Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy.

Key Points: 
  • The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO®[Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy.
  • ALTUVIIIO is indicated for control of bleeding tendency in patients with hemophilia A (factor VIII deficiency).
  • ALTUVIIIO was also recently approved by the Taiwan Food and Drug Administration for treatment of adults and children with hemophilia A on August 31, 2023.
  • The high-sustained factor activity levels will enable patients and physicians to reimagine living with hemophilia.

European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata

Retrieved on: 
Tuesday, September 19, 2023
Biotechnology, Health, Science, Other Science, Pharmaceutical, Janus, Inc., TEC, Civil service commission, Hepatocellular carcinoma, MHLW, PFE, JAK3, European Directive on Traditional Herbal Medicinal Products, ALLEGRO, Medicine, SALT, Alopecia areata, EMA, Committee, Hair, European Commission, Patient, Committee for Medicinal Products for Human Use, Janus kinase 3, European Medicines Agency, FDA, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NYSE, Food, Alopecia totalis, CHMP, Vaccine, Pharmaceutical industry, EU, Pfizer

Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata.
  • LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata.
  • At week 24, 49.2% of participants reported a response of “moderate” to “great” improvement in their alopecia areata compared to 9.2% with placebo.
  • ALLEGRO-LT (NCT04006457) is an ongoing Phase 3, open-label, long-term study, with safety and efficacy data being collected for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years of age with alopecia areata with 50% or greater scalp hair loss.

Shionogi Presents New Ensitrelvir Clinical and Real-World Data Reinforcing Potential Across COVID-19 Populations at ESWI 2023

Retrieved on: 
Monday, September 18, 2023
Health, Infectious Diseases, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, European Scientific Cooperative on Phytotherapy, Influenza, Medical Affairs Bureau, MHLW, SARS-CoV-2, Head, Kidney, Ministry of Health, Labour and Welfare, Fast Track, Research, COVID, Ministry, Ensitrelvir, Patient, Risk, Hearing, Ministry of Health (Saudi Arabia), BMI, Regulation of tobacco by the U.S. Food and Drug Administration, Conference, Cancer, Food, Kidney disease, Pharmaceutical industry, Vaccine, Shionogi

Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.

Key Points: 
  • Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
  • Known as Xocova® in Japan, ensitrelvir received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of SARS-CoV-2 infection in November 2022.
  • In April 2023, ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration.
  • “These results indicate the potential for ensitrelvir to help address these needs.”

Weight-loss Programs Level Up With Smart Wearable Devices

Retrieved on: 
Friday, September 15, 2023
Sequence, CGM, Weight, Insurance, Planet Fitness, Diabetes, Garmin, Classification, Marketing, Obesity, Acquisition, Patient, Digital, Arrhythmia, News, NYSE, Financial News, Male, AMOLED, GRMN, Diet, Cael Sanderson, Smartphone, USD, Motivation, Apple, BMI, Mental health, Empowerment, Exercise, Human, WW International, National Health Service, Stroke, Sleep, Cancer, Pharmaceuticals and Medical Devices Agency, Mind, Zio, IRTC, Vital signs, PMDA, Blood, Heart rate, Hand, Blood pressure, White, Wrist, MHLW, Weight loss, Medication, Samsung, WW, Georgy Shonin, NMRD, Female, Mobile phone, Dietary supplement, Medical device, Birth control, Online shopping, Labour, Nemaura Medical, Health, Amazon

NEW YORK, Sept. 15, 2023 /PRNewswire/ -- The wearable technology market has evolved in recent years into a major tech segment, in large part thanks to consumer market growth which is driven by sales of smartwatches. Major companies like Apple and Samsung are heavily involved in the innovation of wearable devices, which are now capable of performing a wide range of features including cellular connectivity, health monitoring, contactless payment and more. Due to the advanced health monitoring features found in the devices, the wearable technology market is now playing an important role in the medical sector as well. In recent years, the devices have allowed healthcare providers to remotely monitor a patient's various physiological parameters. The most commonly measured data include vital signs such as heart rate, blood pressure, number of calories burned during a day, sleep quality and oxygen level in the blood. Nemaura Medical Inc. (NASDAQ: NMRD), Planet Fitness, Inc. (NYSE: PLNT), WW International, Inc. (NASDAQ: WW), Garmin Ltd. (NYSE: GRMN), iRhythm Technologies, Inc. (NASDAQ: IRTC)

Key Points: 
  • Due to the advanced health monitoring features found in the devices, the wearable technology market is now playing an important role in the medical sector as well.
  • In recent years, the devices have allowed healthcare providers to remotely monitor a patient's various physiological parameters.
  • Nemaura Medical Inc. (NASDAQ: NMRD) announced breaking news earlier this week regarding, "interim results from its metabolic health program.
  • The high medical needs designation in Japan is granted to innovative devices recognized as having high medical utility for significant diseases.