MHLW

Guardant Health Completes Purchase of Guardant Health AMEA Joint Venture

Retrieved on: 
Monday, June 13, 2022
Oncology, Medical Devices, Health, Other Health, General Health, Biotechnology, Â, SoftBank Group, LinkedIn, Annual report, Financial condition report, Security (finance), Helmy Eltoukhy, Disease, U.S. Securities and Exchange Commission, Result, MHLW, Patient, Acquisition, GH, Adoption, Incidence, Research, Analysis, NASDAQ, Twitter, Medical imaging, Cancer, Health

Guardant Health AMEA operations support 41 countries across the region.

Key Points: 
  • Guardant Health AMEA operations support 41 countries across the region.
  • By acquiring the remaining shares of Guardant Health AMEA, we can focus on creating a unified and centralized global organization that delivers on our promise to help conquer cancer and improve patient outcomes, said Helmy Eltoukhy, Guardant Health chairman and co-CEO.
  • In May 2018, Guardant Health and SoftBank Vision Fund established the Guardant Health AMEA joint venture to expand commercialization of Guardant Health's industry-leading liquid biopsy technology across the region.
  • Under the terms of the parties joint venture agreement, Guardant Health paid approximately $177.8 million to acquire the Guardant Health AMEA equity interest held by SoftBank and its affiliates.

Eisai: MHLW Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of ALS

Retrieved on: 
Friday, May 27, 2022
Department, Disease, Neurodegeneration, Patient, Biomedical sciences, Neurology, University of Tokushima, Amyotrophic lateral sclerosis, Ministry, Department of Neurology, Xuanwu hospital, Ministry of Health, Labour and Welfare, Eisai, Principal, Safety, MHLW, NDA, Drug development, ALS, Pharmaceutical industry, Health

TOKYO, May 27, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW).

Key Points: 
  • TOKYO, May 27, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW).
  • ALS is an intractable, progressive, neurodegenerative disease with significant unmet medical needs.
  • In Japan, the estimated number of ALS patients is approximately 10,000.
  • Eisai considers neurology a therapeutic area of focus and is committed to new drug development in this field in order to fulfill unmet medical needs, and ultimately further its contribution to improving the benefit of patients and their families.

Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan

Retrieved on: 
Tuesday, May 10, 2022
JAMA Neurology, Amyotrophic lateral sclerosis, Drug development, Ministry, Phase, Department, Peripheral neuropathy, Ministry of Health, Labour and Welfare, Muscle atrophy, Biomedical sciences, Death, Megaloblastic anemia, Safety, Paralysis, Patient, Respiration (physiology), AMED, Survival, MHLW, Pharmaceuticals and Medical Devices Agency, Japan Agency for Medical Research and Development, Neurodegeneration, New Drug Application, Eisai, Neurology, Ministry of Health (Saudi Arabia), Regeneration, University of Tokushima, Disease, Medication, PMDA, Principal, Research, Muscle, Medicines and Healthcare products Regulatory Agency, ALS, Department of Neurology, Xuanwu hospital, Medical research, Pharmaceutical industry, Methylcobalamin, Health

However, an additional analysis of Study 761 suggested that ultrahigh-dose mecobalamin prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset.

Key Points: 
  • However, an additional analysis of Study 761 suggested that ultrahigh-dose mecobalamin prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset.
  • The results of the study showed the efficacy, safety, and tolerability of ultrahigh-dose mecobalamin, which have now been published in the peer-reviewed journal JAMA Neurology(New Window).
  • Based on the results of JETALS, in consultation with the Tokushima University, Eisai has decided to newly submit the application for approval of ultrahigh-dose mecobalamin for ALS in Japan.
  • ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction.

XOMA Reports First Quarter 2022 Financial Results and Highlights Recent Operational Events

Retrieved on: 
Thursday, May 5, 2022
Economics, COVID-19, Congenital hyperinsulinism, Faricimab, GLOBE, DME, Company, Biotechnology, Securities Exchange Act of 1934, Securities Act of 1933, Roche, Food, Safety, Research, Time, CHI, Patient, COPD, Security (finance), MHLW, Diabetic retinopathy, FDA, Form 10-K, Income, Intention, NAMD, Janssen, Terminology, G&A, Ownership, Acquisition, Pharmaceutical industry, Video game, Lithium, Health, Checkmate

EMERYVILLE, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, reported its first quarter 2022 financial results and provided a recent operations update.

Key Points: 
  • Ended the first quarter of 2022 with cash and restricted cash of $88.6 million and no debt on XOMAs balance sheet.
  • EMERYVILLE, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, reported its first quarter 2022 financial results and provided a recent operations update.
  • On April 25, 2022, Roche reported first quarter 2022 financial results, which included initial faricimab sales7.
  • XOMA recorded total revenues of $3.1 million for the first quarter of 2022, compared with $0.4 million in the first quarter of 2021.

Conavi Medical’s Novasight Hybrid System Now In Use at Sunnybrook Health Sciences Centre

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Thursday, April 28, 2022
General Health, Medical Devices, Health, Clinical Trials, Cardiology, Veteran, Volunteering, CEO, Artery, OCT, Patient, Blood, Education, Sunnybrook Health Sciences Centre, Lithotripsy, Canton, Cardiovascular disease, Health Canada, University, Food, Cancer, Ministry, Rehabilitation, Adoption, Heart, MHLW, Physician, Sunnybrook, Research, Program, Sunnybrook Research Institute, IVUS, SRI, Injury, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medical imaging, Health

Conavi Medical Inc. ( www.conavi.com ), a leader of hybrid imaging guidance for common minimally invasive heart procedures, and Sunnybrook Health Sciences Centre, today announced that the Novasight Hybrid System is now being used for clinical procedures by interventional cardiologists as part of the Schulich Heart Program.

Key Points: 
  • Conavi Medical Inc. ( www.conavi.com ), a leader of hybrid imaging guidance for common minimally invasive heart procedures, and Sunnybrook Health Sciences Centre, today announced that the Novasight Hybrid System is now being used for clinical procedures by interventional cardiologists as part of the Schulich Heart Program.
  • The hybrid intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging platform, now called Novasight Hybrid System, was initially invented at Sunnybrook Research Institute (SRI) by Dr. Brian Courtney, a scientist and interventional cardiologist.
  • In fact, its a key part of our strategic plan, said Andy Smith, President and CEO of Sunnybrook Health Sciences Centre.
  • Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration, and regulatory approval for clinical use from Health Canada, and the Ministry of Health, Labor and Welfare (MHLW) in Japan.

Vedere Bio II Appoints Accomplished Clinician and Researcher Anna-Maria Demetriades as Chief Medical Officer

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Tuesday, April 26, 2022
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CAMBRIDGE, Mass., April 26, 2022 /PRNewswire/ -- Vedere Bio II, Inc., a company developing transformative, next-generation therapies for vision restoration and preservation, today announced the appointment of Anna-Maria Demetriades, M.D., Ph.D. as Chief Medical Officer.Dr.

Key Points: 
  • CAMBRIDGE, Mass., April 26, 2022 /PRNewswire/ -- Vedere Bio II, Inc., a company developing transformative, next-generation therapies for vision restoration and preservation, today announced the appointment of Anna-Maria Demetriades, M.D., Ph.D. as Chief Medical Officer.Dr.
  • "We are very excited to have Anna join our leadership team," said Cyrus Mozayeni, M.D., Chief Executive Officer and President, Vedere Bio II and Atlas Venture Entrepreneur in Residence.
  • Herexpertise will be invaluable to Vedere as we advance our lead program towardthe clinic."
  • "I am thrilled to join the Vedere team as we work to advance and grow our pipeline of pioneering ocular therapies," said Dr. Demetriades.

Takeda Announces Approval of Nuvaxovid® COVID-19 Vaccine for Primary and Booster Immunization in Japan

Retrieved on: 
Tuesday, April 19, 2022
Oncology, Health, Infectious Diseases, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, NDA, Innovative Medicines Initiative, COVID-19, Research, MHLW, Program, Patient, Infection, Genetics, Investment, Public health, Acquisition, Quality of life, Hematology, Knowledge, Ministry of Health, Labour and Welfare, ACTIV, U.S. Securities and Exchange Commission, Medical research, Ageing, Annual report, United States Army Medical Research and Development Command, Fever Dream, Government of Japan, Advertising, Technology transfer, Takeda Pharmaceutical Company, Partnership, Projection, Marketing, CARE, TAK, R, Failure, Plasma, Temperature, IMI, Safety, Immunization, World Health Organization, Therapy, Clinical trial, Fiscal, Intramuscular injection, Pandemic, COVID, Vaccine, Pharmaceutical industry, Vaccine, Neuroscience, Takeda, Health, Gastroenterology

Takeda (TSE:4502/NYSE:TAK) today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.
  • Takeda will begin distribution of Nuvaxovid doses purchased by the Government of Japan as soon as possible.
  • Additional safety and efficacy data were submitted to support booster immunization, including a Phase 2 study conducted by Novavax in South Africa evaluating a booster dose given 6 months after primary immunization.
  • Nuvaxovid is stored at a refrigerated temperature of 2 -8 and will be transported using a conventional vaccine supply chain.

Ardelyx and Kyowa Kirin Amend License Agreement for Tenapanor

Retrieved on: 
Monday, April 11, 2022
Drug development, Therapy, Metabolic acidosis, End-user license agreement, Dialysis, Marketing, Kidney, Knight Therapeutics, Multimedia, Adult, License, MHLW, U.S. Securities and Exchange Commission, View, Hyperkalemia, Hyperphosphatemia, CKD, Fosun Pharma, Annual report, Patient, Kyowa Hakko Kirin, Security (finance), Pharmaceutical industry

Kyowa Kirin is finalizing its Phase 3 clinical program for tenapanor for hyperphosphatemia and has disclosed its current expectation to file for approval with Kyowa Kirin in the second half of 2022 and its current expectation that it will receive a decision from Kyowa Kirin regarding its application in the second half of 2023.

Key Points: 
  • Kyowa Kirin is finalizing its Phase 3 clinical program for tenapanor for hyperphosphatemia and has disclosed its current expectation to file for approval with Kyowa Kirin in the second half of 2022 and its current expectation that it will receive a decision from Kyowa Kirin regarding its application in the second half of 2023.
  • The royalty rate at which Kyowa Kirin will make payments on net sales to Ardelyx under the License Agreement will be reduced from the high teens to low double digits for a two-year period, and then to mid-single digits.
  • "We are pleased to amend our longstanding agreement with Kyowa Kirin in a mutually beneficial way," said Mike Raab, president and chief executive officer of Ardelyx.
  • "We believe that this agreement is reflective of both the positive clinical data Kyowa Kirin has generated for tenapanor and the attractive opportunity for treating hyperphosphatemia in dialysis patients in Japan."

SB623 Demonstrated Sustained Improvement in Motor Impairment up to 48 Weeks and Associated with Improvement in Function and Activities of Daily Living in Patients with Chronic Traumatic Brain Injury

Retrieved on: 
Tuesday, April 5, 2022
Research, Surgery, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Hospital, Regenerative medicine, Stroke, Trial of the century, American Academy of Neurology, Death, Sakigake, Traumatic brain injury, Disability, Global Burden of Disease Study, Veni, vidi, vici, Central nervous system, Bone marrow, Disease, MHLW, Patient, Incidence, Ministry of Health, Labour and Welfare, Medical director, FMMS, Food, Glasgow Outcome Scale, SL, TBI, Quality of life, Stem cell, Safety, Review, Headache, Person, New England Center for Investigative Reporting, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Brain, American Academy, Physical, AAN, FDA, INN, Pharmaceutical industry, Health insurance, Medical device, Meat, Health, Neurology, SB623, TRAUMATIC BRAIN INJURY, THE STEMTRA TRIAL, SANBIO

These findings reinforce the potential for SB623 to provide clinically meaningful improvements in motor function and ability to resume daily activities.

Key Points: 
  • These findings reinforce the potential for SB623 to provide clinically meaningful improvements in motor function and ability to resume daily activities.
  • These improvements in motor impairment were maintained up to 48 weeks in the treatment group.
  • SanBio is preparing to initiate a Phase 3 trial for SB623 in the United States, where many traumatic brain injury patients currently live.
  • SB623 is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke.

Press Release: Xenpozyme® (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency

Retrieved on: 
Monday, March 28, 2022
ASHG, BLA, Private Securities Litigation Reform Act, Cell, Biologics license application, Niemann–Pick disease, European Medicines Agency, NASDAQ, Lung, ASCEND, Forward-looking statement, Death, Sakigake, SNY, Adult, Annual report, Human genetics, Enzyme replacement therapy, ASMD, CNS, Research, SEC, Liver, Social responsibility, Spleen, MHLW, Carbon monoxide, ASM, Medicine, Achievement, Food, Priority, Society, Priority review, American Society of Human Genetics, COVID-19, Regulation of tobacco by the U.S. Food and Drug Administration, Intellectual property, AMF, EMA, Science, Breakthrough, Development, SAN, FDA, Patient, Form 20-F, Research and development, Pharmaceutical industry, Health, Welfare, EU, Sanofi

Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency

Key Points: 
  • Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency
    Paris, March 28, 2022.
  • As the worlds first medicine approved for ASMD, Xenpozyme offers a potentially transformative option for this historically neglected community.
  • We are proud of this achievement and grateful that Japans PDMA has recognized the significance of the unmet need that Xenpozyme addresses with the Sakigake designation.
  • Xenpozyme is a recombinant human acid sphingomyelinase enzyme developed to replace deficient or defective acid sphingomyelinase (ASM), an enzyme that allows for the breakdown of the lipid sphingomyelin.