Medicines and Healthcare products Regulatory Agency

Mirati Therapeutics Receives Approval from the MHRA for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

Retrieved on: 
Friday, November 3, 2023
PD-L1, United Kingdom, NSCLC, Medication, Mirati, Lung cancer, University Hospital (Newark, New Jersey), University Hospitals Birmingham NHS Foundation Trust, MHRA, Immunotherapy, Medicines and Healthcare products Regulatory Agency, Therapy, Patient, Mirati Therapeutics, SAN, Pharmaceutical industry

"KRAZATI offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRASG12C mutation.

Key Points: 
  • "KRAZATI offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRASG12C mutation.
  • "Fourteen percent of people living with NSCLC harbour the KRASG12C mutation yet there are limited targeted treatment options for patients with this devastating disease1,2," said Dr Shobhit Baijal (Consultant Medical Oncologist of The University Hospital Birmingham).
  • "The expansion of treatment options for NSCLC benefits patients and clinicians alike.
  • As someone intensively involved in the management of lung cancer patients, I look forward to KRAZATI being available for use in clinical practice."

AIRS Medical Accelerates Global Expansion, Showcasing clinical achievements of MRI Enhancement Solution at RSNA 2023

Retrieved on: 
Monday, October 30, 2023
Air medical services, Pharmaceuticals and Medical Devices Agency, RSNA, MRI, US, Clinical research, ISO/IEC, US FDA, Medicine, Certification, Research, Medicines and Healthcare products Regulatory Agency, Radiology, PMDA, Growth, Theatre, Abstract, ISO, MDSAP, Medical device, Medical imaging

Attending at RSNA 2023 as an AI showcase sponsor, showcasing clinical achievements with two AI Theater Presentations and two accepted abstracts.

Key Points: 
  • Attending at RSNA 2023 as an AI showcase sponsor, showcasing clinical achievements with two AI Theater Presentations and two accepted abstracts.
  • SEOUL, South Korea, Oct. 30, 2023 /PRNewswire/ -- AIRS Medical has shown remarkable growth in global market expansion.
  • AIRS Medical will showcase SwiftMR™, an AI-powered MRI enhancement solution at RSNA2023, the largest radiological conference in North America on November 24~29th.
  • AIRS Medical accelerates international expansion with the recent certification of Japan's Pharmaceuticals and Medical Devices Agency (PMDA) on October 13th.

Life Molecular Imaging and Sinotau Pharmaceutical Group Announce the Regulatory Approval of their Amyloid PET Imaging Radiopharmaceutical Neuraceq® in China

Retrieved on: 
Tuesday, October 24, 2023
Alzheimer's disease, Amyloid, FDA, LMI, United Kingdom, Trial of the century, AD, Radiopharmaceutical, NMPA, Plaque, MCI, Food, Medication, Physician, European Medicines Agency, Dementia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, PET, Disease, MHRA, National Medical Products Administration, EMA, Brain, Medicines and Healthcare products Regulatory Agency, GMP, Patient, Diagnosis, Medical imaging

BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China. Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer's disease (AD). It visualizes beta-amyloid plaque accumulation in the brain, an established biomarker for AD. Neuraceq® (欧韦宁®) will be manufactured by Sinotau and made commercially available. With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline. The density of amyloid plaques can be assessed to guide early diagnosis and patient management.

Key Points: 
  • BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China.
  • Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer's disease (AD).
  • With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline.
  • "Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer which can be imaged through PET-CT/MRI is the first approved Aβ-PET tracer in China and the first approved PET tracer in China in recent 20 years.

Meridian Medical Technologies, LLC, and the European Commission’s DG HERA Sign Agreement for 13 Countries From the EEA to Purchase Tecovirimat SIGA

Retrieved on: 
Monday, October 23, 2023
Other Defense, Infectious Diseases, Contracts, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Defense, European Economic Area, Vaccinia, Medication, SIGA Technologies, Cowpox, Health Emergency Preparedness and Response Authority, Mpox, Meridian Medical Technologies, European Medicines Agency, JPA, MHRA, European, HERA, Smallpox, Tecovirimat, EMA, Joint, Gross metropolitan product, Medicines and Healthcare products Regulatory Agency, Health technology, Patient, Vaccine, Nursing, Meridian, EEA, EU

Meridian Medical Technologies, LLC (Meridian), a global health security leader in providing medical countermeasures, today announced a framework contract under the Joint Procurement Agreement (JPA) was signed between Meridian and the European Commission’s Directorates-General (DG) HERA (Health Emergency Preparedness and Response Authority).

Key Points: 
  • Meridian Medical Technologies, LLC (Meridian), a global health security leader in providing medical countermeasures, today announced a framework contract under the Joint Procurement Agreement (JPA) was signed between Meridian and the European Commission’s Directorates-General (DG) HERA (Health Emergency Preparedness and Response Authority).
  • As part of a promotional licensing agreement, Meridian is a global commercialization partner for SIGA Technologies, Inc. (NASDAQ: SIGA), which is the marketing authorization holder and manufacturer of Tecovirimat SIGA.
  • Under the JPA, 13 participating countries from the European Economic Area (EEA) (Contracting Parties) can now efficiently purchase Tecovirimat SIGA, which has been approved by the European Medicines Agency (EMA) and Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications.
  • This agreement will result in country-level procurement of oral Tecovirimat SIGA and serve as a template for future procurement opportunities.

Pearl’s Second Opinion® Dental AI Platform Cleared in Turkey

Retrieved on: 
Wednesday, October 18, 2023
Health, Dental, Technology, Health Technology, Artificial Intelligence, Medication, Turkish Medicines and Medical Devices Agency, Estonia, Crown, Medicines and Healthcare products Regulatory Agency, Osteoporosis, Dentist, Impacted wisdom teeth, Machine learning, Radioactive decay, Patient, Calculus, Second, Medical device, Dentistry, Pearl

Pearl , the global leader in dental AI solutions, today announced that its Second Opinion® chairside dental pathology detection aid has received clearance from the Turkish Medicines and Medical Devices Agency (TMMDA) as a Class IIa medical device.

Key Points: 
  • Pearl , the global leader in dental AI solutions, today announced that its Second Opinion® chairside dental pathology detection aid has received clearance from the Turkish Medicines and Medical Devices Agency (TMMDA) as a Class IIa medical device.
  • Pearl’s AI delivers its findings in real-time for patient-facing display in the dental operatory, helping dentists ensure the accuracy of their x-ray evaluations and enabling them to better communicate diagnoses to patients.
  • “At Pearl, it is our mission to equip dental practices around the world with the most clinically advanced AI on the market,” said Ophir Tanz, Founder and CEO of Pearl.
  • “Designed to advance consistent high quality and doctor-patient communication, Second Opinion®’s authorization for use in Turkey will deliver the unrivaled clinical benefits of AI to one of the fastest growing dental markets in the world.”

Elsevier Launches New Pharmapendium, Empowering Pharma Companies to Bring Novel Drugs to Market Faster and Increase Success of Regulatory Submissions

Retrieved on: 
Tuesday, October 10, 2023
Investment, Eli Lilly and Company, Data science, DMPK, Food, Pharmacokinetics, Drug Efficacy Study Implementation, Drug development, Pharma, Meyler, Food and Drug Administration, Drug, Novartis, EMA, FDA, PMDA, Chemistry, Medicines and Healthcare products Regulatory Agency, Human, European Medicines Agency, Boehringer Ingelheim, Pharmaceutical industry, Laboratoires Servier, Elsevier, Medication

Comprehensive drug development and approval package data combined with predictive analytics support translational research, reduce animal testing and ensure drug safety

Key Points: 
  • PharmaPendium enables companies to make faster, more informed decisions about what drug candidates to advance.
  • Pharma professionals and researchers can use the tool to benchmark against competitors, prioritize safety and efficacy, and develop effective strategies for regulatory submissions.
  • The depth and reliability of the platform's data means PharmaPendium is already trusted by the FDA, Pharmaceuticals and Medical Devices Agency (PMDA) and the top 20 global pharma companies.
  • "This improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies."

Athersys Reports Interim Analysis Results of MASTERS-2 Clinical Study with MultiStem in Ischemic Stroke, Signs Memorandum of Understanding (MOU) for Global ARDS License with Healios

Retrieved on: 
Tuesday, October 10, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Shift, MOU, 3D, Bankruptcy, Regenerative medicine, DSMB, PMDA, Medicines and Healthcare products Regulatory Agency, Clutch (eggs), Data analysis, Patient, Sale, Pharmaceutical industry

Separately, Athersys announces that it has entered into a Memorandum of Understanding (MOU) granting HEALIOS K.K. (Healios) global rights to develop and commercialize MultiStem for the treatment of acute respiratory distress syndrome (ARDS). Under the terms of the MOU, Athersys will receive between $1.5M and $4.5M in near term payments with up to $150 million in potential development and sales milestones and additional royalties. Athersys also expects to receive revenue from the sale of existing clinical doses of MultiStem-- which were manufactured in accordance with its 3D bioreactor process that earlier this year received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)--for Healios to use in its Phase 3 clinical trial in ARDS.

Key Points: 
  • Because the sample size required to achieve statistical significance is considerably larger, Athersys intends to conduct additional data analysis with independent statisticians.
  • The Company plans to pause enrollment of new patients while this analysis is being conducted.
  • Separately, Athersys announces that it has entered into a Memorandum of Understanding (MOU) granting HEALIOS K.K.
  • (Healios) global rights to develop and commercialize MultiStem for the treatment of acute respiratory distress syndrome (ARDS).

CEL-SCI Files Request With the UK’s MHRA Regarding Path to Approval for Multikine in the Treatment of Head & Neck Cancer

Retrieved on: 
Thursday, October 5, 2023
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, United, Medicines and Healthcare products Regulatory Agency, NYSE, Consultant, Health Canada, Radiation, European Medicines Agency, Survival, EMA, MHRA, ESMO, Immunotherapy, Head, European Society for Medical Oncology, Conference, Patient, Pharmaceutical industry

These new results arose from an improved selection algorithm of the Multikine target population.

Key Points: 
  • These new results arose from an improved selection algorithm of the Multikine target population.
  • This improved selection algorithm is able to more accurately predict the patients who would benefit most from the Multikine therapy.
  • We are extremely excited about the results seen in the newly defined Multikine target population.”
    CEL-SCI’s pivotal Phase 3 study tested Multikine in newly diagnosed locally advanced head and neck cancer patients.
  • The dire need for a new and effective treatment for newly diagnosed locally advanced primary head and neck cancer is widely recognized in the medical community.

Northwest Biotherapeutics Provides Update On Near Term Plans For Submission of Marketing Authorization Application

Retrieved on: 
Friday, October 13, 2023
MHRA, Medicines and Healthcare products Regulatory Agency, OTCQB, Northwest Biotherapeutics, Glioblastoma, Marketing, Consultant, Medication, Biotechnology, MAA, Pharmaceutical industry

The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.

Key Points: 
  • The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.
  • The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard.
  • With this timeline, the submission of the MAA to the MHRA would take place between mid and late November.
  • The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.

Northwest Biotherapeutics Provides Update On Near Term Plans For Submission of Marketing Authorization Application

Retrieved on: 
Friday, October 13, 2023
MHRA, Medicines and Healthcare products Regulatory Agency, OTCQB, Northwest Biotherapeutics, Glioblastoma, Marketing, Consultant, Medication, Biotechnology, MAA, Pharmaceutical industry

The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.

Key Points: 
  • The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.
  • The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard.
  • With this timeline, the submission of the MAA to the MHRA would take place between mid and late November.
  • The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.