Ministry of Health, Labour and Welfare

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Tuesday, February 28, 2023
Amyloid beta, Ministry of Health, Labour and Welfare, Lecanemab, Alzheimer's disease, Ministry, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, Brain, Research, The New England Journal of Medicine, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Key Points: 
  • TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Monday, February 27, 2023
Ministry of Health, Labour and Welfare, Lecanemab, Ministry, BIIB, Corporation, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, The New England Journal of Medicine, Brain, Research, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Headquarters, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.

Key Points: 
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Shionogi Presents Pivotal Ensitrelvir Fumaric Acid Phase 3 Data and Exploratory Long COVID Data at CROI

Retrieved on: 
Tuesday, February 21, 2023
Infectious Diseases, COVID-19, Health, Pharmaceutical, Clinical Trials, Ensitrelvir, Ministry of Health, Labour and Welfare, Ministry, Omicron, Ministry of Health (Saudi Arabia), Fungal infection, Head, Cough, Conference, Generic, CROI, COVID, Sore throat, MHLW, Pharmaceutical industry, Study, Shionogi

Shionogi also presented exploratory data from the Study evaluating the potential effect of ensitrelvir on the symptoms of long COVID.

Key Points: 
  • Shionogi also presented exploratory data from the Study evaluating the potential effect of ensitrelvir on the symptoms of long COVID.
  • Regarding safety, ensitrelvir was well tolerated, and there were no serious treatment-related adverse events or deaths in the Study.
  • “A treatment addressing the symptoms of long COVID remains one of the largest unmet needs of the pandemic.
  • "As these data are from an exploratory analysis, this promising signal will hopefully be followed up with further evaluation of ensitrelvir for long COVID.”

Shionogi Advances Ensitrelvir Fumaric Acid COVID-19 Antiviral Clinical Program

Retrieved on: 
Wednesday, February 15, 2023
Health, COVID-19, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ministry of Health (Saudi Arabia), MHLW, AIDS Clinical Trials Group, Epidemic, Standard of care, SARS-CoV-2, Therapy, Urinary tract infection, ACTIV, World Health Organization, Diagnosis, Bangladesh Technical Education Board, NIH, Safety, Patient, Pediatric Trials Network, Ensitrelvir, HIV, Medicines Patent Pool, Ministry, Risk, WHO, NIAID, ACTG, Head, Partnership, Generic, Ministry of Health, Labour and Welfare, AIDS, Public, Prevalence, Infection, Developing country, Pharmaceutical industry, Vaccine, Shionogi

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on its comprehensive clinical development program for the novel 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 progress on its comprehensive clinical development program for the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • The program includes several Phase 3 clinical studies evaluating ensitrelvir’s safety and effectiveness across a wide range of COVID-19 patient populations.
  • Ensitrelvir is the first drug to be evaluated in the STRIVE program, a new agile research approach set up to rapidly assess interventions during epidemics adversely affecting public health.
  • Pediatric Trial: Shionogi plans to initiate a Phase 3 pediatric study evaluating the safety and effectiveness of ensitrelvir for children ages 6-12 in Japan, starting in early 2023.

Shin-Nihon Public Affairs Announces Yasuhisa Shiozaki to join as Special Advisor

Retrieved on: 
Wednesday, February 1, 2023
Consulting, Health, Genetics, Professional Services, Oncology, Government, Kohara, Genetic distance, Drug resistance, Welfare, Study Group, Action plan, AMR, Policy, Knowledge, Politics, Head, Ministry of Health, Labour and Welfare, Multimedia, Iraq Study Group, Cancer, Pharmaceutical industry, Labour

Shin-Nihon Public Affairs Co. (Head Office: Tokyo; President: Yasushi Kohara) today announced Mr. Yasuhisa Shiozaki as special advisor.

Key Points: 
  • Shin-Nihon Public Affairs Co. (Head Office: Tokyo; President: Yasushi Kohara) today announced Mr. Yasuhisa Shiozaki as special advisor.
  • Mr. Shiozaki is a former Chief Cabinet Secretary, and Minister of Health, Labour and Welfare, and is well versed in an extremely wide range of policy areas.
  • When he served as Minister of Health, Labour, and Welfare, he led to launch the Action Plan for Whole Genome Analysis, etc.
  • to promote genomic medicine for cancer and intractable diseases, and strongly promoted data health reform.

Bristol Myers Squibb Announces Positive CHMP Opinion for Once-Daily Sotyktu (deucravacitinib) as a Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

Retrieved on: 
Friday, January 27, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Ministry of Health, Bristol Myers Squibb, TYK2, European Commission, Journal, CHMP, Light, Apremilast, NYSE, Lower respiratory tract infection, Civil service commission, Patient, Face, Committee, Skin, Folliculitis, Food, Ministry, BMY, Committee for Medicinal Products for Human Use, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American Academy, FDA, Journal of the American Academy of Dermatology, Ministry of Health, Labour and Welfare, Quality of life, Psoriasis, European, PSO, MD, Pharmaceutical industry, Deucravacitinib, EU

Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis.
  • Sotyktu, an oral medication taken once-daily, is a first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
  • The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
  • Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.

transcosmos inc. becomes a registered Kanagawa SDGs Partner

Retrieved on: 
Friday, February 10, 2023
Ministry of Health, Labour and Welfare, Society, Organization, Disability, Sustainable Development Goals, Woman, Ministry, Food, Person, Partnership, Employment, Sustainable Development Goals and Ghana, Transport, Ironworks, Tourism, Kerosene, Health, Kanagawa Prefecture, Transcosmos Stadium Nagasaki

TOKYO, Feb. 10, 2023 /PRNewswire-PRWeb/ -- transcosmos inc. is proud to announce that the company has been registered as a Kanagawa SDGs Partner.

Key Points: 
  • With the goal of achieving a sustainable & inclusive society, helps raise awareness of SDGs
    TOKYO, Feb. 10, 2023 /PRNewswire-PRWeb/ -- transcosmos inc. is proud to announce that the company has been registered as a Kanagawa SDGs Partner.
  • Kanagawa prefecture invites, registers and announces companies and organizations that operate businesses that help promote and achieve the Sustainable Development Goals (SDGs) under its program, Kanagawa SDGs Partner ( https://www.pref-kanagawa-jp.translate.goog/docs/bs5/sdgs/partner.html?_... ).
  • Through this program, Kanagawa prefecture aims to promote and spread activities towards achieving SDGs in partnership with the companies, etc.
  • As a business with its footprints in Kanagawa prefecture, transcosmos supports the prefecture's initiatives, Kanagawa SDGs Partner and Kanagawa Charter for a Society Living Together in Harmony, and registered as a partner.

Brand Institute's Vice President of Creative Nomenclature Explains the Pharmaceutical Brand Name Review Process Used by Japanese Regulators

Retrieved on: 
Tuesday, January 31, 2023
Brand Institute, US, Ministry, Ministry of Health, Labour and Welfare, Ministry of Health, MHLW, Government, Vaccine, Pharmaceutical industry, Health

Pharmaceutical manufacturers will submit brand name proposals to a health agency for review, and that agency will assess those names for similarity to existing brand names in that country or region.

Key Points: 
  • Pharmaceutical manufacturers will submit brand name proposals to a health agency for review, and that agency will assess those names for similarity to existing brand names in that country or region.
  • If a name is too similar to another name based on that agency's guidelines, the proposed brand name may be rejected.
  • "In Japan, the brand name review process is much different," said Sanae Suga, Brand Institute's Vice President of Creative Nomenclature.
  • English brand names are transliterated into katakana, a component of the Japanese writing system.

Akron Bio Receives Eligibility Confirmation from PMDA in Japan for the Commercialization of Virus Inactivated Human Fibronectin in Clinical Cell Therapy Manufacturing

Retrieved on: 
Tuesday, January 17, 2023
Research, Genetics, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, Other Science, Science, DMF, Bio, Ministry of Health, Labour and Welfare, PMDA, Safety, MHLW, Ministry, FDA, Plasma, Medicines and Healthcare products Regulatory Agency, Ministry of Health (Saudi Arabia), CGMP, CFR, Pharmaceutical industry, Vaccine

Akron Bio (“Akron”), a leading supplier of critical inputs for cell and gene therapies, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted Akron Eligibility Confirmation for its cGMP Virus Inactivated Human Fibronectin.

Key Points: 
  • Akron Bio (“Akron”), a leading supplier of critical inputs for cell and gene therapies, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted Akron Eligibility Confirmation for its cGMP Virus Inactivated Human Fibronectin.
  • Akron's Virus Inactivated Human Fibronectin has been on the market for nearly a decade and is a top choice for facilitating the attachment and proliferation of different anchorage-dependent cells during cell therapy manufacturing.
  • This eligibility confirmation from the Japanese regulatory authorities is another example of Akron products being recognized by regulatory authorities as safe and compliant.
  • Akron’s Virus Inactivated Human Fibronectin is manufactured, tested, and released following relevant cGMP guidelines for ancillary materials and is specifically formulated for cell therapy manufacturing applications.

Medacta Group SA: First NextAR surgeries in Japan with the award-winning NextAR Augmented Reality Surgical Platform

Retrieved on: 
Sunday, January 22, 2023
Education, TM, Ministry, 3D ultrasound, Ministry of Health, Labour and Welfare, Anatomy, Surgeon, SAN, TKA, Patient, CT, Ecosystem, Medicine, AR, Computer-assisted orthopedic surgery, MHLW, Smartglasses, NEXTAR, Spine, Medical device, Health

CASTEL SAN PIETRO, 10 January 2023 – Medacta is pleased to announce the first NextAR TM surgeries have been successfully performed in Japan with its innovative NextAR, Augmented Reality Surgical Platform.

Key Points: 
  • CASTEL SAN PIETRO, 10 January 2023 – Medacta is pleased to announce the first NextAR TM surgeries have been successfully performed in Japan with its innovative NextAR, Augmented Reality Surgical Platform.
  • NextAR is the first surgical platform to offer personalized augmented reality solutions for both joint replacement and spine procedures leveraging patient-specific, unique real-time data to efficiently complement operative workflow.
  • NextAR represents a new dimension for enabling technologies, seamlessly integrating into well-established surgical workflows,” says Francesco Siccardi, Chief Executive Officer of Medacta International.
  • The NextAR surgical platform is part of Medacta's MySolutions Personalized Ecosystem , an advanced network of digital solutions designed to improve patient outcomes and healthcare efficiency.