Ministry of Health (Saudi Arabia)

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.

Mexico Needs mpox Vaccine, Says AHF and Vaccine Advocates in The Lancet Letter

Retrieved on: 
Wednesday, March 8, 2023
LGBTQ+, AIDS, Health, Consumer, Infectious Diseases, Pharmaceutical, Science, Bangladesh Technical Education Board, Travel, Public sector, Federal Commission for the Protection against Sanitary Risk, Mpox, CDC, Ministry of Health (Saudi Arabia), Public health emergency of international concern, Infection, Vaccine, European Medicines Agency, MPOX, Ministry, Centers for Disease Control and Prevention, AIDS Healthcare Foundation, Risk, HIV, Disease, STI, AHF, WHO, Director general, Death, Public, NGO, COVID-19, Letter, Policy, Viral disease, Trade Wars, COFEPRIS, World Health Organization, Oregon Higher Education Coordinating Commission, SSA, Ministry of Health, Pharmaceutical industry, Medical device, EU, Lancet

The European Medicines Agency and the US FDA have also authorized the use of the vaccine.

Key Points: 
  • The European Medicines Agency and the US FDA have also authorized the use of the vaccine.
  • Among the authors of this study is the highest decision-maker in public health in Mexico, Dr. Hugo López-Gatell, Undersecretary of Health.
  • The letter was accepted and finally published by the same magazine in its correspondence section titled " MPOX vaccines are needed in Mexico ,” on March 6, 2023.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare .

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.

Pfizer Expands ‘An Accord for a Healthier World’ Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries

Retrieved on: 
Tuesday, January 17, 2023
Professional Services, Philanthropy, Medical Supplies, Environmental, Social and Governance (ESG), Health, Other Philanthropy, Pharmaceutical, Inc., Hospital, Cancer, AMR, PFE, NYSE, Vaccine, Hope, Oral cancer, Health equity, Collaboration, Disease, Mortality, Medicine, Ministry of Health (Saudi Arabia), Infection, Pharmaceutical industry, Accord, Pfizer

However, to better align with disease burden and unmet patient needs in these countries, Pfizer will now expand its offering under the Accord to include off-patent products, bringing the total offering from 23 products to around 500 products.

Key Points: 
  • However, to better align with disease burden and unmet patient needs in these countries, Pfizer will now expand its offering under the Accord to include off-patent products, bringing the total offering from 23 products to around 500 products.
  • The Accord portfolio offering now includes both patented and off-patent medicines and vaccines that treat or prevent many of the greatest infectious and non-communicable disease threats faced today in lower-income countries.
  • This includes chemotherapies and oral cancer treatments that have the potential to treat nearly one million new cancer cases in Accord countries each year1.
  • As Pfizer launches new medicines and vaccines, those products will also be included in the Accord portfolio on a not-for-profit basis.

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.

AHF Eswatini Commemorates 15th Year with New Centre of Excellence!

Retrieved on: 
Friday, January 13, 2023
Oncology, AIDS, Philanthropy, Health, Foundation, General Health, Pharmaceutical, Local-level governments of Papua New Guinea, AIDS Healthcare Foundation, TB, Population Services International, Entrepreneurship, Education, AIDS, HIV, Matsapha, Medicine, Government, Ministry, Center of excellence, Cervical cancer, Kingdom, Georgetown University, MOH, FLAS, Partnership, Pharmacy, Woman, Growth, Patient, HIV/AIDS, AHF, Ministry of Health (Saudi Arabia), SZL, PSI, Member, ART, Multimedia, Watts Labor Community Action Committee, Pharmaceutical industry, Medical device

View the full release here: https://www.businesswire.com/news/home/20230112005861/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230112005861/en/
    As part of its commemoration of 15 years in the country, AHF Eswatini will unveil its newly constructed state-of-the-art LaMvelase Centre of Excellence in partnership with the Manzini City Council on Jan. 13.
  • (Photo: Business Wire)
    As part of its commemoration, AHF Eswatini will unveil its newly constructed state-of-the-art LaMvelase Centre of Excellence in partnership with the Manzini City Council (who provided the land on which the clinic sits).
  • Although providing treatment was AHF Eswatini’s foremost priority, it has attained much more in over a decade.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare .

Qualigen Therapeutics Provides Update on Developments at NanoSynex; Significant Progress Reported on Infectious Disease Diagnostic Platform

Retrieved on: 
Thursday, January 5, 2023
Innovation, Fungus, Cancer, Microsoft, Laniado Hospital, Antimicrobial resistance, Bacteria, Ministry, Therapy, Infection, Orphan, Virus, InterAction Council of Former Heads of State and Government, Ministry of Health (Saudi Arabia), BFM Business, CE, Letter, European Committee on Antimicrobial Susceptibility Testing, Parasitism, FDA, Hospital, BIOMED, Tel Aviv Stock Exchange, Prevalence, Survival, AST, Pharmaceutical industry, Antibiotics, Medical imaging, Medical device, Health, Bloodstream infections

Michael Poirier, Qualigen’s Chairman and CEO stated: “We are very encouraged by the milestones achieved and progress made to date by our partners in Israel.

Key Points: 
  • Michael Poirier, Qualigen’s Chairman and CEO stated: “We are very encouraged by the milestones achieved and progress made to date by our partners in Israel.
  • We believe NanoSynex’s AST may represent a breakthrough diagnostic test in the critical area of infectious disease.
  • Key accomplishments this year include:
    Closed majority investment transaction with our strategic partner Qualigen Therapeutics for enhanced product development and commercialization of our novel antimicrobial susceptibility test platform.
  • Completed development of our latest system design composed of disposable test cards, benchtop reader and real time data analysis software.