Ministry of Health, Labour and Welfare

ITANDI, a Japanese real estate company shows its support to the "Orange Ribbon Anti Child Abuse Movement"

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Friday, September 9, 2022
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provides services in the real estate industry (mainly in the rental and leasing sector) announced that it is working with the Japan Network for Prevention of Child Abuse and Neglect (NPO organization) and becomes one of the partners that supports the "Orange ribbon anti child abuse movement".

Key Points: 
  • provides services in the real estate industry (mainly in the rental and leasing sector) announced that it is working with the Japan Network for Prevention of Child Abuse and Neglect (NPO organization) and becomes one of the partners that supports the "Orange ribbon anti child abuse movement".
  • To prevent such tragic event from happening again, the Oyama city started this "Orange ribbon anti child abuse movement" to rise the awareness of child abuse.
  • Such a tragic case of child abuse is not rare, an average of more than 50 cases of child abuse were reported a year in Japan.
  • Finally, we will be adding "the support of anti child abuse movement" to our list as our 7th sustainability goals.

RECELL System Insurance Coverage Begins in Japan for Treatment of Acute Burns

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Thursday, September 1, 2022
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We will utilize the capabilities of our robust team to support the successful launch of RECELL in Japan, said Mr. Tatsuro Tsutsumi, CEO of COSMOTEC.

Key Points: 
  • We will utilize the capabilities of our robust team to support the successful launch of RECELL in Japan, said Mr. Tatsuro Tsutsumi, CEO of COSMOTEC.
  • The RECELL System technology platform, approved by the FDA for the treatment of acute thermal burns in both adults and children, harnessesthe regenerative properties of a patients own skin to create Spray-On Skin cells.
  • In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, acute traumatic wounds, vitiligo, and aesthetics.
  • The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan.

Myriad Genetics Receives Expanded Coverage in Japan for Use of BRACAnalysis® Diagnostic System as a Companion Diagnostic for Lynparza® in Early-Stage Breast Cancer

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Thursday, August 25, 2022
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This most recent coverage expansion confirms the benefits of using biomarkers to help guide care for patients with breast cancer, said Nicole Lambert, chief operating officer, Myriad Genetics.

Key Points: 
  • This most recent coverage expansion confirms the benefits of using biomarkers to help guide care for patients with breast cancer, said Nicole Lambert, chief operating officer, Myriad Genetics.
  • BRACAnalysis Diagnostic System is designed to detect and interpret germline BRCA1 and BRCA2 variants.
  • The test identifies deleterious or suspected deleterious germline BRCA variants in patients with HER2-negative high-risk early breast cancer.
  • BRACAnalysis is a diagnostic system that classifies a patients clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes.

Brand Institute Partners on Brand Name Development for Treatment of Relapsed or Refractor Peripheral T-Cell Lymphoma Now Approved by Ministry of Health, Labour and Welfare (Japan)

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Tuesday, July 5, 2022
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DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors.

Key Points: 
  • DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors.
  • DARVIAS has been approved for relapsed or refractory Peripheral T-Cell Lymphoma by Japan's Ministry of Health, Labour and Welfare (MHLW).
  • "The entire Brand Institute and Drug Safety Institute team congratulates Solasia on the MHLW approval of the DARVIAS injection," said Brand Institute's Chairman and C.E.O., James L. Dettore.
  • The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers.

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

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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.

Galapagos to showcase commitment to rheumatoid arthritis care at the upcoming European League Against Rheumatism congress

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Wednesday, May 25, 2022
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Mechelen, Belgium; 25 May 2022, 22.01 CET; Galapagos NV (Euronext & Nasdaq: GLPG) will present 11 abstracts at the European League Against Rheumatism (EULAR) congress 2022, 01-04 June, taking place in Copenhagen, Denmark.

Key Points: 
  • Mechelen, Belgium; 25 May 2022, 22.01 CET; Galapagos NV (Euronext & Nasdaq: GLPG) will present 11 abstracts at the European League Against Rheumatism (EULAR) congress 2022, 01-04 June, taking place in Copenhagen, Denmark.
  • A meet-the-expert session, Patient-centred care in RA: cutting through the jargon will feature insights and answers to audience questions on putting patients at the heart of their RA care.
  • Additionally, Galapagos will present preclinical data on selective SIK3 (salt-inducible kinase) inhibition as a novel mode of action for the treatment of RA.
  • Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.

LUCA Science and Kyowa Kirin Announce Joint Research Agreement on Mitochondrial Disease Treatment With Novel Mitochondria Modality

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Wednesday, May 18, 2022
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LUCA Science Inc. (LUCA Science, Tokyo, Japan) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, Tokyo, Japan, TSE:4151) are pleased to announce they have entered into a research collaboration agreement on the treatment of mitochondrial diseases using platform of an innovative mitochondrial modality.

Key Points: 
  • LUCA Science Inc. (LUCA Science, Tokyo, Japan) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, Tokyo, Japan, TSE:4151) are pleased to announce they have entered into a research collaboration agreement on the treatment of mitochondrial diseases using platform of an innovative mitochondrial modality.
  • View the full release here: https://www.businesswire.com/news/home/20220517005653/en/
    Through this research collaboration, Kyowa Kirin, a leading specialty pharmaceutical company with deep disease science research knowledge based on diverse experiences in biopharmaceutical drug discovery, will leverage LUCA Science's proprietary functional mitochondria therapy platform to develop an innovative treatment for mitochondrial diseases.
  • LUCA Science has a deep-rooted commitment to finding a cure for mitochondrial disease.
  • We are excited to collaborate with Kyowa Kirin to advance research in mitochondrial disease treatment with our novel modality to further demonstrate the potential of mitochondria as a biopharmaceutical agent.

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

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Tuesday, May 10, 2022
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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.

OPKO Health Reports 2022 First Quarter Business Highlights and Financial Results

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Monday, May 9, 2022
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MIAMI, May 09, 2022 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended March 31, 2022.

Key Points: 
  • MIAMI, May 09, 2022 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended March 31, 2022.
    Business highlights for the first quarter of 2022 and subsequent weeks include the following:
    Acquired ModeX Therapeutics, Inc. (ModeX), gains proprietary immunotherapy technology, new executives and Directors.
  • BioReference processed approximately 2.0 million COVID-19 PCR tests in the first quarter of 2022 versus 4.1 million in the first quarter of 2021.
  • Operating loss for the first quarter of 2022 was $72.4 million compared with operating income of $38.5 million for the 2021 quarter.
  • Also, OPKO expects to receive $85 million in milestone payments from Pfizer during the second quarter of 2022.

RIBOMIC Announces Completion of IND Submission for an Observational Study for Continuous Phase 2 Trial of RBM-007 for Treatment of Achondroplasia

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Tuesday, April 19, 2022
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RBM-007 has been shown to have potent effects in limiting excessive interactions between fibroblast growth factors, which are known to cause achondroplasia.

Key Points: 
  • RBM-007 has been shown to have potent effects in limiting excessive interactions between fibroblast growth factors, which are known to cause achondroplasia.
  • Achondroplasia is a rare disease characterized by short stature (adult height of approximately 130 cm for males and approximately 125 cm for females) with short limbs.
  • Achondroplasia has no known cure, and is designated as an intractable disease by the Ministry of Health, Labour and Welfare in Japan.
  • "RIBOMIC," "RiboART system" and the RIBOMIC logo are registered trademarks or trademarks of RIBOMIC Inc. in various jurisdictions.