Brazilian Health Regulatory Agency

Completion of PIC/S Participating Authorities' Audits of Kexing Biopharm's Licensed Product Infliximab for Injection

Retrieved on: 
Tuesday, April 2, 2024
Certification, Brazilian Health Regulatory Agency, News, EPO, ANVISA, GMP, PIC/S, Infliximab, Food

New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.

Key Points: 
  • New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.
  • In addition, this month, the product has undergone a site GMP audit by another PIC/S Participating Authority, the Indonesian Food and Drug Authority (BPOM).
  • The company's proprietary product, human erythropoietin (EPO), has been present in Indonesia since 2005, gaining popularity and increasing market share.
  • In terms of infliximab, progress has been remarkable in the overseas factory inspection since the third quarter of 2023.

Avicanna Reports Full Year 2023 Audited Financial Results 

Retrieved on: 
Tuesday, April 2, 2024
Cream, Cannabidiol, Cannabinoid, Dravet syndrome, Brazilian Health Regulatory Agency, Interest, Medical cannabis, Seizure, Business, Lennox–Gastaut syndrome, Patient, Pharmacy, Active ingredient, Research, Acquisition, RDC, Ultra, Stock, CBD, Insurance, Health Canada, Bank statement, GMP, Dermatology, TSX, Therapy, Pharmaceutical industry

TORONTO, April 02, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce year end 2023 results and audited financial statements.

Key Points: 
  • TORONTO, April 02, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce year end 2023 results and audited financial statements.
  • Cash used in operations of $1.38 million; an 81% reduction compared to $7.4 million in 2022.
  • “2023 was a tremendous year for Avicanna where we solidified of our leadership position in the Canadian medical cannabis sector through our proprietary products and the launch of MyMedi.ca.
  • We have successfully demonstrated the scalability of our revenues and made significant improvements in our fundamentals while advancing all our business pillars.

MediPharm Labs Reports Fourth Quarter and Full Year Results

Retrieved on: 
Wednesday, March 27, 2024
OPEX, Brazilian Health Regulatory Agency, CFO, International, Webcast, Patient, VIVO, Research, Good manufacturing practice, Acquisition, Prescription, ANVISA, GMP, Adjustment, TSX, Cannabis, Good, THC, Marketing, Fine chemical

TORONTO, March 27, 2024 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, today announced its financial results for the full year and three months ended December 31, 2023.

Key Points: 
  • TORONTO, March 27, 2024 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, today announced its financial results for the full year and three months ended December 31, 2023.
  • MediPharm has two medical cannabis products with ANVISA authorizations and will increase deliveries to a new pharma partner in 2024.
  • David Pidduck, CEO, MediPharm Labs commented, "MediPharm now has the margins, Opex and Adjusted EBITDA results all trending in the right direction.
  • We are proud of the work completed in 2023 and excited about the future of MediPharm Labs."

Radformation Receives Regulatory Clearances for Automation Solutions in Australia, Brazil, Canada, and Thailand

Retrieved on: 
Thursday, February 22, 2024
Software, Oncology, Health, FDA, Artificial Intelligence, Hospitals, Health Technology, Technology, ANVISA, Health Canada, Brazilian Health Regulatory Agency, TGA, Safety, Therapeutic Goods Administration, Patient, Radiation, Research, Workflow, Medical imaging

“These clearances reflect our commitment to global healthcare innovation and our dedication to meet the rigorous regulatory standards essential to improve patient care worldwide” said Kurt Sysock, CEO of Radformation.

Key Points: 
  • “These clearances reflect our commitment to global healthcare innovation and our dedication to meet the rigorous regulatory standards essential to improve patient care worldwide” said Kurt Sysock, CEO of Radformation.
  • Included in these clearances is AutoContour, Radformation’s AI-driven auto-segmentation and contouring solution designed to jump start the treatment planning process.
  • “By harnessing the speed and standardization offered by AutoContour and ClearCheck, we’ve significantly streamlined our pre-treatment processes”, said Pedro.
  • *The Thai Food and Drug Administration clearance applies specifically to Radformation products AutoContour and EZFluence.

MediPharm Labs Achieves Pharmaceutical GMP Certification with Brazilian Health Authority

Retrieved on: 
Wednesday, February 7, 2024
Growth, Certification, TGA, THC, Prescription, Patient, US FDA, CAD, FDA, Brazilian Health Regulatory Agency, TSX, CBD, API, Health Canada, ANVISA, GMP, Drug

MediPharm Labs is the first purpose-built pharmaceutical cannabis company in North America to receive a GMP certificate from the Brazilian Health Regulatory Agency (ANVISA), for production of cannabis finished goods.

Key Points: 
  • MediPharm Labs is the first purpose-built pharmaceutical cannabis company in North America to receive a GMP certificate from the Brazilian Health Regulatory Agency (ANVISA), for production of cannabis finished goods.
  • TORONTO, Feb. 7, 2024 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce receipt of GMP certification for their Barrie, Ontario facility from ANVISA, the governing body of Brazil's pharmaceutical industry.
  • MediPharm Labs now has GMP certification from the United States FDA, European Union, Australia's TGA and holds a drug establishment license from Health Canada.
  • The certification joins our long list of global regulatory achievements, including US FDA, Australian TGA, European Union pharmaceutical GMP and Canadian pharmaceutical GMP authorizations.

Health Canada Approves UPLIZNA® (inebilizumab for injection) for the Treatment of Neuromyelitis Optica Spectrum Disorders (NMOSD)

Retrieved on: 
Tuesday, January 16, 2024
Death, Fellow, Patient, Therapy, Ottawa Hospital Research Institute, Multiple sclerosis, Paratriathlon, University, ANVISA, Autoimmune disease, Risk, Food, Disease, Central nervous system, Labour, Ministry of Health, FDA, Pain, Physician, Inflammation, NMOSD, Clinical trial, B cell, Health Canada, Paralysis, Brazilian Health Regulatory Agency, Pharmaceutical industry

-- NMOSD is a devastating autoimmune disease of severe and recurrent central nervous system attacks which can result in blindness, paralysis and death –

Key Points: 
  • "Just a single NMOSD attack can have a life-altering impact, including pain, debilitation and irreversible vision loss.
  • Health Canada based its approval of UPLIZNA on results from the N-MOmentum pivotal trial ( 2014-000253-36 ), the largest NMOSD clinical trial to date.
  • UPLIZNA demonstrated a significant reduction in the risk of an NMOSD attack with only two infusions per year, following the initial loading doses.
  • "We can now accurately diagnose NMOSD, which is distinctly different from MS and warrants specific treatment.

Pulsenmore Receives Brazilian ANVISA Approval for Its Prenatal Home Ultrasound Solution

Retrieved on: 
Wednesday, January 10, 2024
Pregnancy, Patient, ANVISA, Brazilian Health Regulatory Agency, Prenatal care, Medical imaging

RAMAT GAN, Israel, Jan. 10, 2024 /PRNewswire/ -- Pulsenmore (TASE: PULS), the global leader in self-scan ultrasound technology for home use, proudly announces the approval of its pioneering prenatal care solution by the Brazilian Health Regulatory Agency (ANVISA), marking a significant milestone in the company's international expansion.

Key Points: 
  • RAMAT GAN, Israel, Jan. 10, 2024 /PRNewswire/ -- Pulsenmore (TASE: PULS), the global leader in self-scan ultrasound technology for home use, proudly announces the approval of its pioneering prenatal care solution by the Brazilian Health Regulatory Agency (ANVISA), marking a significant milestone in the company's international expansion.
  • The approval underscores Pulsenmore's commitment to transforming the landscape of prenatal care, offering a groundbreaking solution for expectant mothers and healthcare organizations alike.
  • The approval from ANVISA now enables Pulsenmore to provide Brazilian health organizations and consumers with unparalleled access to this transformative solution, reducing the necessity for in-clinic visits and offering a continuous, personalized healthcare experience.
  • We are excited about the positive impact Pulsenmore can bring to Brazilian healthcare, ushering in a new era of accessible and high-quality prenatal care."

IceCure Medical Reports Financial Results as of and for the Nine Months Ended September 30, 2023, and Provides Update on Recent Operational Highlights

Retrieved on: 
Wednesday, November 15, 2023
Lung, Woman, CIRSE, Freezing, Patient, Participation, Research, Kidney, Marketing, Neoplasm, Conference, Congress, System, ICE3, Hamas, Webcast, Safety, Food, Luminate (company), European Society of Radiology, Conference call, ANVISA, Health, Breast, Cryoablation, Breast cancer, Kidney cancer, Nine Months, Classification, Brazilian Health Regulatory Agency, Prostate, Health Canada, De novo, Circulatory system, Liver, Novomer, Episcopal conference, FDA, Cancer Diagnostic Probe, Medical device, Pharmaceutical industry, Nursing, Medical imaging, Birth control, Cryptocurrency, Broadcasting, Luminal

Gross profit was $0.73 million for the nine months ended September 30, 2023, compared to $0.98 million for the nine months ended September 30, 2022.

Key Points: 
  • Gross profit was $0.73 million for the nine months ended September 30, 2023, compared to $0.98 million for the nine months ended September 30, 2022.
  • Gross margin was 37% for the nine months ended September 30, 2023, compared to 46% for the nine months ended September 30, 2022.
  • Research and development expenses for the nine months ended September 30, 2023, were $6.39 million compared to $6.89 million for the nine months ended September 30, 2022.
  • Total operating expenses for the nine months ended September 30, 2023, were $12.89 million, compared to $13.79 million for the nine months ended September 30, 2022.

Empaveli is the first treatment for PNH that binds to the complement protein C3.

Retrieved on: 
Tuesday, October 17, 2023
Biotechnology, General Health, Pharmaceutical, Health, ANVISA, Partnership, Bureau of Oceans and International Environmental and Scientific Affairs, Multimedia, Brazilian Health Regulatory Agency, Pharma, Paroxysmal nocturnal hemoglobinuria, PNH, System, Rare, Hematology, Patient, Quality of life, Hemolysis, Pharmaceutical industry

Pint Pharma and OrphanDC announced on July 25th that ANVISA, the National Health Surveillance Agency, approved, on July 25th, 2023, the drug EMPAVELI® (pegcetacoplan, indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)).

Key Points: 
  • Pint Pharma and OrphanDC announced on July 25th that ANVISA, the National Health Surveillance Agency, approved, on July 25th, 2023, the drug EMPAVELI® (pegcetacoplan, indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)).
  • Empaveli is the first treatment for PNH that binds to the complement protein C3.
  • View the full release here: https://www.businesswire.com/news/home/20231017388408/en/
    ANVISA, Brazilian National Health Surveillance Agency, approves EMPAVELI® medication for the treatment of PNH (Photo: Business Wire)
    PNH is a rare, chronic, and life-threatening blood disease in which uncontrolled complement activation leads to the destruction of red blood cells through intravascular hemolysis and extravascular hemolysis.
  • “The approval of Empaveli by ANVISA is a milestone for people living with PNH in Brazil, as PNH symptoms can significantly affect patients' quality of life,” said David Munoz, CEO and president of Pint Pharma.

Horizon Therapeutics plc Announces New UPLIZNA® (inebilizumab-cdon) Data in Neuromyelitis Optica Spectrum Disorder (NMOSD) to be presented at ECTRIMS 2023

Retrieved on: 
Monday, October 2, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Civil service commission, ANVISA, Azathioprine, Multiple sclerosis, Congress, European Commission, Evaluation, CEST, Brazilian Health Regulatory Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Treatment, Food, Pharmaceutical industry, NMOSD, Inebilizumab, Patient

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new UPLIZNA analyses will be presented at the 39th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2023, Oct. 11-13.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new UPLIZNA analyses will be presented at the 39th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2023, Oct. 11-13.
  • UPLIZNA is the first and only targeted CD19+ B-cell-depleting therapy approved by the U.S. Food and Drug Administration, the European Commission and the Brazilian Health Regulatory Agency (ANVISA) for the treatment of NMOSD in adults who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+).
  • P015: Association of Cytokine Proteins with Disease Activity in NMOSD Participants Receiving Inebilizumab Treatment (S. Pittock)
    P409: Long-Term Comparative Efficacy of Inebilizumab in the AQP4+ Subpopulation from the N-MOmentum Open-Label Extension Versus Azathioprine and Immunosuppressive Therapies and Versus Placebo in Patients with NMOSD (B. Cree)
    P011: Matching-Adjusted Indirect Comparison of Current Treatments for NMOSD and Evaluation of Long-Term Effectiveness (F. Paul)
    Horizon will host a symposium Thursday, Oct. 12 from 8:45 to 9:45 a.m. CEST, “Looking for unrecognized disease activity in NMOSD to optimize treatment choice and prevent disability,” chaired by Massimo Filippi, M.D., Ph.D., featuring presentations from Maria Rocca, M.D., Orhan Aktas, M.D.
  • and Jeffrey Bennett, M.D., Ph.D.