Brazilian Health Regulatory Agency

Global Orthopedic Regenerative Medicine Market to 2028 - Featuring Anika Therapeutics, Baxter International and Stryker Among Others - ResearchAndMarkets.com

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Friday, February 4, 2022
Health, Pharmaceutical, Foam, Organic, Growth, Cartilage, Brazilian Health Regulatory Agency, Risk, Tissue engineering, CGMP, Cell, Food, Food and Drug Administration, Bone marrow, Tissue, Research, Partnership, ANVISA, Muhlenbergia rigens, Pain, Region, FDA, Therapy, Lists of diseases, B cell, Medical device, Pharmaceutical industry

Regenerative orthopedic medicines can help in healing damaged tissues, and improve the discomfort and pain which occurred due to musculoskeletal diseases.

Key Points: 
  • Regenerative orthopedic medicines can help in healing damaged tissues, and improve the discomfort and pain which occurred due to musculoskeletal diseases.
  • Orthopedic regenerative medicines help in healing injuries of ligament, tendon, bone, spinal disc, muscle, cartilage, and musculoskeletal tissues.
  • Market players are indulged in receiving approvals from regulatory authorities for the treatment of orthopedic diseases, which is expected to drive the growth of the global orthopedic regenerative medicine market over the forecast period.
  • Increasing inorganic activities by market players such as collaborations, partnerships, and agreements is expected to drive the growth of the global orthopedic regenerative medicine market over the forecast period.

Versius adopted for urological procedures in Pakistan

Retrieved on: 
Thursday, January 20, 2022
General surgery, Nephrology, Patient, Technology, News, Organ transplantation, Sindh Institute of Urology & Transplantation, SIUT, CMR Surgical, Hernia, Vision Guided Robotic Systems, Time, Degenerative disease, CMR, Father Muller Charitable Institutions, Hospital, Patient safety, GMT, Dentistry, Medical device, Brazilian Health Regulatory Agency, Transplant

At SIUT, Versius is being used as part of a multispecialty programme, beginning with urological procedures and later expanding into general surgery

Key Points: 
  • At SIUT, Versius is being used as part of a multispecialty programme, beginning with urological procedures and later expanding into general surgery
    Cambridge, United Kingdom.
  • CMR Surgical the global surgical robotics business has today announced the successful completion of high-volume urological procedures at the Sindh Institute of Urology and Transplantation (SIUT) using the next generation surgical robotic system, Versius, in Pakistan.
  • Completing over 100 cases within two months, SIUT have rapidly integrated Versius into high-volume complex urological procedures, including cystectomies, prostatectomies and radical nephrectomies.
  • Versius will be used as part of a multispecialty robotics programme, later being used for a range of general surgery procedures, including cholecystectomies and hernia repairs.

Versius adopted for urological procedures in Pakistan

Retrieved on: 
Thursday, January 20, 2022
General surgery, Nephrology, Patient, Technology, News, Organ transplantation, Sindh Institute of Urology & Transplantation, SIUT, CMR Surgical, Hernia, Vision Guided Robotic Systems, Time, Degenerative disease, CMR, Father Muller Charitable Institutions, Hospital, Patient safety, GMT, Dentistry, Medical device, Brazilian Health Regulatory Agency, Transplant

At SIUT, Versius is being used as part of a multispecialty programme, beginning with urological procedures and later expanding into general surgery

Key Points: 
  • At SIUT, Versius is being used as part of a multispecialty programme, beginning with urological procedures and later expanding into general surgery
    Cambridge, United Kingdom.
  • CMR Surgical the global surgical robotics business has today announced the successful completion of high-volume urological procedures at the Sindh Institute of Urology and Transplantation (SIUT) using the next generation surgical robotic system, Versius, in Pakistan.
  • Completing over 100 cases within two months, SIUT have rapidly integrated Versius into high-volume complex urological procedures, including cystectomies, prostatectomies and radical nephrectomies.
  • Versius will be used as part of a multispecialty robotics programme, later being used for a range of general surgery procedures, including cholecystectomies and hernia repairs.

PTC Therapeutics Provides an Update on Commercial Progress and R&D Pipeline at 40th Annual J.P. Morgan Healthcare Conference

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Monday, January 10, 2022
PKU, Amyotrophic lateral sclerosis, Cardinal, Brazilian Health Regulatory Agency, Growth, Duchenne muscular dystrophy, Standard of care, Committee, Volanesorsen, DMD, Phenylketonuria, Investor, Biologics license application, CHMP, Patient, Duchenne, PTC Therapeutics, Spinal muscular atrophy, SG, Conference, NASDAQ, GAAP, ALS, ANVISA, Classification, PTC, Therapy, European Medicines Agency, Committee for Medicinal Products for Human Use, Union, Seizure, AADC, Mitochondrial disease, Huntington's disease, Prescription, European Directive on Traditional Herbal Medicinal Products, Mission statement, Key, FDA, EMA, BLA, SMA, Roche, Medical device, Animal, Video game, Pharmaceutical industry, Medicine, Vaccine, Ataluren, Risdiplam, Deflazacort

SOUTH PLAINFIELD, N.J., Jan. 10, 2022 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) will present an update on its commercial progress and R&D pipeline at the 40th Annual J.P. Morgan Healthcare Conference today, Monday Jan. 10th at 7:30am EST.

Key Points: 
  • SOUTH PLAINFIELD, N.J., Jan. 10, 2022 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) will present an update on its commercial progress and R&D pipeline at the 40th Annual J.P. Morgan Healthcare Conference today, Monday Jan. 10th at 7:30am EST.
  • Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics, will provide an update on 2021 accomplishments and highlight upcoming potential value-creating milestones.
  • The presentation will be webcast live on the Events and Presentations page of the Investors section of PTC Therapeutics website at www.ptcbio.com .
  • PTC successfully advanced its clinical pipeline in 2021:
    APHENITY, a Phase 3 registration-directed trial of PTC923 in phenylketonuria (PKU) was initiated.

Waylivra™ Receives Innovative Drug Category Pricing to Treat Familial Chylomicronemia Syndrome in Brazil

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Tuesday, January 4, 2022
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Waylivra is the only treatment for familial chylomicronemia syndrome (FCS) in Brazil.

Key Points: 
  • Waylivra is the only treatment for familial chylomicronemia syndrome (FCS) in Brazil.
  • Category 1 classification is given to innovative treatments that provide greater efficacy than current standards of care, and it allows for pricing in line with international markets.
  • If approved, Waylivra will be the first approved treatment for FPL in Brazil, and this will mark the first approval globally for this indication.
  • "I am pleased withthe decision by CMED to grant FCS patients access to Waylivra in Brazil.

Ada's medical AI solutions obtain registration as a class II medical device in Brazil

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Tuesday, December 14, 2021
Ada, Organization, Solution, Growth, ANVISA, NEW, Patient, Brazilian Health Regulatory Agency, Technology, Health, Certification, Medical device

BERLIN, NEW YORK and BRASLIA, Brazil, Dec. 14, 2021 /PRNewswire/ --Ada Health, the global digital health company, announced today that its AI powered symptom assessment and care navigation platform has obtained class II medical device status in Brazil.

Key Points: 
  • BERLIN, NEW YORK and BRASLIA, Brazil, Dec. 14, 2021 /PRNewswire/ --Ada Health, the global digital health company, announced today that its AI powered symptom assessment and care navigation platform has obtained class II medical device status in Brazil.
  • The Brazilian health regulatory agency, ANVISA (Agncia Nacional de Vigilncia Sanitria) , sets strict standards for companies seeking class II medical device status and requires suppliers to show clinical evidence and follow transparent quality management processes.
  • Ada prides itself on the rigorous evaluation of its medical AI solutions, ensuring that it meets the most ambitious industry standards across several global markets.
  • Ada's Class II medical device status provides additional assurances for health organizations in Brazil that apply strict standards to their own and their suppliers' offerings and value proven clinical excellence.

Ada's medical AI solutions obtain registration as a class II medical device in Brazil

Retrieved on: 
Tuesday, December 14, 2021
Solution, Health, Ada Health, Technology, Patient, Ada, NEW, Brazilian Health Regulatory Agency, Growth, ANVISA, Certification, Organization, Medical device

BERLIN, NEW YORK and BRASÍLIA, Brazil, Dec. 14, 2021 /PRNewswire/ -- Ada Health, the global digital health company, announced today that its AI powered symptom assessment and care navigation platform has obtained class II medical device status in Brazil. Ada is the first and only AI-driven digital health assessment platform to achieve this in Brazil, demonstrating the company's continual commitment to medical and regulatory excellence.

Key Points: 
  • - Global digital health company Ada Health continues to strengthen its position as a leading provider of trusted medical AI by obtaining registration as a medical device in Brazil.
  • - Today's announcement is expected to further reinforce client interest in the vetted benefits of Ada's medical AI solutions.
  • BERLIN, NEW YORK and BRASLIA, Brazil, Dec. 14, 2021 /PRNewswire/ --Ada Health, the global digital health company, announced today that its AI powered symptom assessment and care navigation platform has obtained class II medical device status in Brazil.
  • Ada's Class II medical device status provides additional assurances for health organizations in Brazil that apply strict standards to their own and their suppliers' offerings and value proven clinical excellence.

CytoDyn’s CRO in Brazil Met with ANVISA to Modify CD16 Trial for Critically Ill COVID-19 Patients to Expedite Interim Analysis After 51 Patients, Potentially in 1Q2022

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Wednesday, December 8, 2021
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By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the USA, patients received only two weekly doses of 700 mg of leronlimab via sub-cutaneous injections.

Key Points: 
  • By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the USA, patients received only two weekly doses of 700 mg of leronlimab via sub-cutaneous injections.
  • The primary endpoint in this study was based on the valuable information we had generated from the past CD12 trial.
  • The p-value for length of hospital stay for the critically ill patients who were on invasive mechanical ventilator or ECMO was 0.005.
  • The primary endpoint of the CD16 trial in Brazil is Time to Recovery, which is similar to this endpoint.

Illuccix® Granted Use Authorisation for Prostate Cancer Imaging in Brazil

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Tuesday, November 30, 2021
GMP, Patient, Man, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Prostate cancer, Prostate, Radiopharmaceutical, CEO, Brazilian Health Regulatory Agency, Lung cancer, Company, ASX, Injection, Cancer, Male, TGA, MTR, RPH, Physician, Gallium, GLOBE, PET, Innovation, PSMA, FDA, Kit, TLX, Australian Securities Exchange, Nuclear medicine, Grupo Protege, LinkedIn, Disease, Degenerative disease, Food, Medical imaging

Illuccix (Kit for the preparation of 68Ga PSMA-11 Injection) is a positron emission tomography (PET) imaging agent targeting prostate specific membrane antigen (PSMA) for the staging of prostate cancer.

Key Points: 
  • Illuccix (Kit for the preparation of 68Ga PSMA-11 Injection) is a positron emission tomography (PET) imaging agent targeting prostate specific membrane antigen (PSMA) for the staging of prostate cancer.
  • Dr. Christian Behrenbruch, CEO and Managing Director of Telix said, Prostate cancer is the most commonly diagnosed male cancer in Brazil, with approximately 65,840 new cases each year.2 PSMA-PET imaging has the potential to have a profound impact on the management of prostate cancer, enabling clinicians to detect prostate cancer right throughout the body.
  • We look forward to working closely with our partner RPH to facilitate widespread patient access to Illuccix for men living with prostate cancer in Brazil.
  • Illuccix (TLX591-CDx) is a preparation for imaging prostate cancer with positron emission tomography (PET), targeting prostate specific membrane antigen (PSMA), a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.

Marrone Bio Submits Regulatory Packages for Nematicides/Insecticides in United States and Brazil

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Monday, November 1, 2021
Online, IBAMA, Research, LinkedIn, ANVISA, China Biologic Products, Environment, MBI, MBII, Twitter, Security (finance), U.S. Securities and Exchange Commission, Adoption, NASDAQ, Private Securities Litigation Reform Act, Crop protection, Ministry, EPA, Brazilian Health Regulatory Agency, Review, Leadership, Social media, Forward-looking statement, Marketing, Daniel Grant, Instagram, Tree, Brazilian Institute of Environment and Renewable Natural Resources, Movement, Ministry of Agriculture (Azerbaijan), COVID-19, Nut, Soybean, Institute, GLOBE, Vegetable, Sale, Risk management

With estimated peak potential revenue in excess of $100 million for both products, MBI-306 and its variants and MBI-206 will be important contributors to advancing Marrone Bios growth and leadership in crop bioprotection.

Key Points: 
  • With estimated peak potential revenue in excess of $100 million for both products, MBI-306 and its variants and MBI-206 will be important contributors to advancing Marrone Bios growth and leadership in crop bioprotection.
  • MBI-206 has been submitted for approval in Brazil for two uses: as a seed treatment and as a foliar/in-furrow product.
  • The companys commercial products are sold globally and supported by a robust portfolio of more than 500 issued and pending patents.
  • Additional information that could lead to material changes in the companys performance is contained in its filings with the Securities and Exchange Commission.