MHLW

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.

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.

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Sunday, January 29, 2023
Medicines and Healthcare products Regulatory Agency, Marketing, Disease, MAA, NMPA, Food, Neurotoxicity, Clarity, Pharmaceuticals and Medical Devices Agency, Headquarters, Corporation, National Medical Products Administration, European Medicines Agency, Medication, MHLW, Phase, BLA, Co-promotion, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, BIIB, AD, The New England Journal of Medicine, Eisai, EMA, PMDA, Priority review, Pharmaceutical industry, Biogen, Health

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

Key Points: 
  • Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
  • In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

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.

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Monday, January 30, 2023
Disease, The New England Journal of Medicine, Alzheimer's disease, European Medicines Agency, PMDA, National Medical Products Administration, Amyloid beta, Priority review, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MHLW, FDA, AD, Medication, Marketing, Pharmaceuticals and Medical Devices Agency, Food, Neurotoxicity, Medicines and Healthcare products Regulatory Agency, Eisai, BLA, Co-promotion, NMPA, Clarity, Phase, MAA, EMA, Pharmaceutical industry, Health, Biogen

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

Key Points: 
  • Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
  • In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • Lecanemab selectively binds and eliminates soluble, toxic Abeta aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

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.

MediWound Expands NexoBrid’s Global Presence with Marketing Approval in Japan

Retrieved on: 
Friday, December 23, 2022
Regeneration, Patient, MHLW, Bromelain (pharmacology), Marketing, Pharmaceutical industry, Health, Welfare

YAVNE, Israel, Dec. 23, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that its partner, Kaken Pharmaceutical Co., Ltd. has gained marketing approval of NexoBrid® in Japan. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive right to market and distribute NexoBrid in Japan. Kaken Pharmaceutical expects to launch NexoBrid in the summer of 2023.

Key Points: 
  • Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive right to market and distribute NexoBrid in Japan.
  • NexoBrid is approved under the orphan drug designation granted by the MHLW as a priority review for unmet medical needs.
  • “This approval further supports our global commercialization strategy to expand the use of NexoBrid to international markets via collaborations with local partners and through additional marketing approvals.”
    Hiroyuki Horiuchi, President and Representative Director of Kaken Pharmaceutical said, “We are very excited to partner with MediWound and bring NexoBrid to patients in Japan.
  • We look forward to making it the standard of care in Japan.”

Basilea announces regulatory approval of antifungal Cresemba® (isavuconazole) in Japan

Retrieved on: 
Sunday, January 22, 2023
Aspergillosis, Mucormycosis, Ministry, Ministry of Health, Labour and Welfare, AKP, Cryptococcosis, Ministry of Health (Saudi Arabia), Mycosis, Growth, Patient, World Health Organization, MHLW, Pharmaceutical industry, Isavuconazonium, EU, Health

Japanese regulatory authority granted marketing authorization to Basilea’s license partner, Asahi Kasei Pharma

Key Points: 
  • Japanese regulatory authority granted marketing authorization to Basilea’s license partner, Asahi Kasei Pharma
    Intravenous and oral use of Cresemba approved for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis
    Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its license partner Asahi Kasei Pharma (“AKP”), has received the marketing authorization from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Cresemba® (isavuconazole) for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis.
  • Aspergillosis and cryptococcosis were recently listed by the World Health Organization as most critical fungal infections that pose a major health risk.1
    David Veitch, Basilea’s CEO, stated: “We congratulate our partner AKP on the approval of Cresemba in Japan, which is an important commercial market for newer antifungals.
  • We look forward to continue working together with AKP to make Cresemba available to patients for whom invasive fungal infections can pose a serious threat.”
    Cresemba is approved in 69 countries to date and is currently marketed in 59 countries, including the United States, China, most EU member states and additional countries inside and outside of Europe.
  • In the twelve months between July 2021 and June 2022, total global in-market sales of Cresemba amounted to USD 352 million, a 24 percent growth year-on-year.2

Japan Ministry of Health, Labor and Welfare Approves Manufacturing and Marketing of Adtralza® (tralokinumab) in Japan for Adults with Atopic Dermatitis

Retrieved on: 
Friday, December 23, 2022
Biotechnology, Pharmaceutical, Health, Dermatology, Leo Pharma, Patient, Investment, MHLW, LEO, National Association Medical Staff Services, Atopic dermatitis, Marketing, Pharmaceutical industry, Health, Tralokinumab

LEO Pharma A/S, a global leader in medical dermatology, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza® (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza® (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies.
  • “Today’s approval is a significant advancement for those patients in Japan who continue to suffer from the often-debilitating symptoms of atopic dermatitis and are in need of a new treatment option to manage their chronic condition,” said Kook Hyun Son, General Manager of LEO Pharma K.K.
  • “The Japan approval is a demonstration of our strategy to expand the availability of Adtralza to millions of patients around the world who are faced with the daily challenges of living with chronic and often debilitating symptoms of atopic dermatitis,” said Becki Morison, executive vice president of global strategy and international operations, LEO Pharma A/S.
  • 6,7

Yescarta® Now Approved in Japan for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma

Retrieved on: 
Thursday, December 22, 2022
Oncology, Health, Hospitals, Genetics, Pharmaceutical, Biotechnology, HDT, Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, Standard of care, Daiichi Sankyo, ASCT, SOC, Multimedia, B-cell lymphoma, Non-Hodgkin lymphoma, CAR, Patient, MHLW, CD19, Standard, EFS, TSE, Pharma, Doctor of Philosophy, Pharmaceutical industry, Health, Axicabtagene ciloleucel

Yescarta should be used only in patients who have not received prior transfusion of CAR T-cells targeted at CD19 antigen.

Key Points: 
  • Yescarta should be used only in patients who have not received prior transfusion of CAR T-cells targeted at CD19 antigen.
  • Although approximately 60% of newly diagnosed LBCL patients will respond to the initial treatment with chemotherapy, 40% will relapse or will not respond and need second-line treatment.
  • Yescarta is now approved for the initial treatment of R/R LBCL patients in Japan.
  • Kite’s manufacturing facility in El Segundo, California, U.S., has been approved by Japanese regulatory authorities to commence manufacturing Yescarta for the Japan market in 2023.