Ministry of Health, Labour and Welfare

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.

Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed Relapsed and/or Refractory Multiple Myeloma

Retrieved on: 
Monday, April 17, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, European Medicines Agency, Bristol Myers Squibb, NYSE Arca Major Market Index, Progression-free survival, Multiple myeloma, The New England Journal of Medicine, New Drug Application, Ministry of Health, Labour and Welfare, Cytopenia, BMY, EMA, Ministry, CAR, Market, Shanda, Cytokine release syndrome, Patient, Cell, PDUFA, United Kingdom, Ministry of Health, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Safety, Pharmaceutical industry, Idecabtagene vicleucel

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 16, 2023.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 16, 2023.
  • Data from KarMMa-3 were published in The New England Journal of Medicine on February 10, 2023.
  • In addition, Japan's Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Abecma based on the KarMMa-3 study.
  • Abecma is also approved in the European Union, Switzerland, the United Kingdom, Japan, Canada, and Israel for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after three to four or more prior lines of therapy.

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.

transcosmos inc. becomes a registered Kawasaki SDGs Partner

Retrieved on: 
Wednesday, April 12, 2023
Employment, Disability, NPO Splav, Ministry of Health, Labour and Welfare, Person, Sustainable Development Goals, Organization, Ministry, School, Sustainable Development Goals and Ghana, Transport, Kerosene, Health, Transcosmos Stadium Nagasaki

TOKYO, April 12, 2023 /PRNewswire-PRWeb/ -- transcosmos inc. is proud to announce that the company has become a registered Kawasaki SDGs Partner.

Key Points: 
  • The Kawasaki SDGs Partner program is run by Kawasaki city.
  • Under this program, Kawasaki city registers and certifies businesses and organizations that take actions to help achieve the Sustainable Development Goals (SDGs).
  • Today, a total of 3,145 (405 registered, 2,740 certified) businesses, organizations, NPOs, schools and various other members across industries are registered and certified as Kawasaki SDGs Partners.
  • As a business with its footprints in Kawasaki city, transcosmos supports the Kawasaki SDGs Partner program, and is now registered as a partner.

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.

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.

Legend Biotech Reports Full-Year 2022 Results and Recent Highlights

Retrieved on: 
Thursday, March 30, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Information technology, Progression-free survival, MHLW, Ministry of Health, Labour and Welfare, Janssen, Privacy, PFS, Government, SCLC, Investigational New Drug, Patient, Investment, Janssen Pharmaceuticals, Growth, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, BCMA, Pharmaceutical industry, Cryptocurrency

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its full year 2022 audited financial results.

Key Points: 
  • Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its full year 2022 audited financial results.
  • "2022 was a year of significant milestones for Legend Biotech, marked by the regulatory approvals of CARVYKTI® in the U.S., Europe, and Japan.
  • Legend Biotech elected to borrow an incremental $130.3 million as of December 31, 2022 in accordance with the terms of the Janssen Agreement.
  • The warrant was assessed as a financial liability with a fair value of $67.0 million as of December 31, 2022.

Eisai Receives the "Basic Achievement Grand Prize" at the 2023 J-Win Diversity Award

Retrieved on: 
Friday, March 10, 2023
Acquisition, D&I, DE, Ministry of Health, FY, D, Armourers and Brasiers' Company Prize, Ministry of Health, Labour and Welfare, Empowerment, NPO, Organization, Ministry, Diversity, Female, Patient, Accreditation, Basic category, Ministry of Economy, Trade and Industry, Equity, Knowledge, The Excellence in Diversity Awards, Eisai, Collaborative innovation network, R, Auction, Nursing, Health

TOKYO, Mar 10, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it was selected as the winner of the "Basic Achievement Grand Prize" at the "2023 J-Win Diversity Award" held by non-profit organization Japan Women's Innovative Network (NPO J-Win).

Key Points: 
  • TOKYO, Mar 10, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it was selected as the winner of the "Basic Achievement Grand Prize" at the "2023 J-Win Diversity Award" held by non-profit organization Japan Women's Innovative Network (NPO J-Win).
  • The "J-Win Diversity Award" has been held annually since 2008 with the aim of accelerating the promotion of diversity and inclusion (D&I) in Japanese companies by awarding leading businesses that are promoting D&I.
  • - Plans to introduce a new personnel assessment system from FY 2023, which utilizes a behavioral assessment item "Diversity & Synergy" to further focus on diversity.
  • Eisai aims to realize the spiral of knowledge generated by diversity, regardless of differences in nationality, gender, age, etc., leading to the creation of innovation.