PMDA

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.

QIAGEN and Myriad Genetics partner to advance companion diagnostics development for cancer

Retrieved on: 
Thursday, October 26, 2023
Survival, QGEN, FDA, NYSE, Myriad Genetics, Genetics, SRL Diagnostics, PCR, Health, Cell, MYGN, Circulating tumor DNA, Senior, PMDA, Research fellow, NGS, Partnership, Cancer, MRD, Workflow, Myriad, HRD, GMP, QIAGEN, Patient, Neoplasm, DNA, Vaccine, Medical device

The alliance between QIAGEN and Myriad brings together the respective strengths of each partner.

Key Points: 
  • The alliance between QIAGEN and Myriad brings together the respective strengths of each partner.
  • Myriad leverages its CLIA-certified, CAP-accredited lab platform, assay development expertise and robust commercial infrastructure for clinical sample testing.
  • Our partnership aims to accelerate the advancement of cancer companion diagnostics, making them accessible to pharma partners worldwide,” said Jonathan Arnold, Vice President, Head of Translational Science and Precision Diagnostics at QIAGEN.
  • Myriad has provided testing support for hundreds of clinical trials, has obtained 10 companion diagnostic approvals from the FDA and PMDA, and anticipates that the QIAGEN partnership will drive the expansion of the Myriad portfolio of oncology products.

QIAGEN and Myriad Genetics partner to advance companion diagnostics development for cancer

Retrieved on: 
Thursday, October 26, 2023
Survival, QGEN, FDA, NYSE, Myriad Genetics, Genetics, SRL Diagnostics, PCR, Health, SALT, Cell, MYGN, Circulating tumor DNA, Senior, PMDA, Research fellow, NGS, Partnership, Cancer, MRD, Workflow, Myriad, HRD, GMP, QIAGEN, Patient, Neoplasm, DNA, Vaccine, Medical device

The alliance between QIAGEN and Myriad brings together the respective strengths of each partner.

Key Points: 
  • The alliance between QIAGEN and Myriad brings together the respective strengths of each partner.
  • Myriad leverages its CLIA-certified, CAP-accredited lab platform, assay development expertise and robust commercial infrastructure for clinical sample testing.
  • Our partnership aims to accelerate the advancement of cancer companion diagnostics, making them accessible to pharma partners worldwide,” said Jonathan Arnold, Vice President, Head of Translational Science and Precision Diagnostics at QIAGEN.
  • Myriad has provided testing support for hundreds of clinical trials, has obtained 10 companion diagnostic approvals from the FDA and PMDA, and anticipates that the QIAGEN partnership will drive the expansion of the Myriad portfolio of oncology products.

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).

Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval

Retrieved on: 
Wednesday, October 4, 2023
Surgery, Medical Devices, Health, Clinical Trials, Cardiology, Elixir, Percutaneous coronary intervention, Medicine, Plaque, AC 25.1309-1, BRS, CAD, Pharmaceuticals and Medical Devices Agency, Catheter, TLF, PCI, Resolute, Motion, Catheterization laboratory, Standard of care, Patient, Physician, PMDA, Division, Randomized controlled trial, Stent, Coronary artery disease, Pharmaceutical industry

Elixir Medical , a developer of disruptive cardiovascular technologies, announced submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) for the approval of the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease (CAD).

Key Points: 
  • Elixir Medical , a developer of disruptive cardiovascular technologies, announced submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) for the approval of the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease (CAD).
  • DynamX coronary bioadaptor was developed to overcome the limitations of drug-eluting stents (DES) and bioresorbable scaffolds (BRS).
  • “Our submission for approval in Japan is an exciting milestone for the company and industry.
  • The DynamX coronary bioadaptor represents a culmination of major design and manufacturing breakthroughs and three clinical trials consistently demonstrating differentiated functional performance compared to the standard of care,” said Motasim Sirhan, CEO of Elixir Medical.

Phillips-Medisize Teams with GlucoModicum to Develop an Innovative Needle-Free Continuous Glucose Monitor

Retrieved on: 
Tuesday, October 3, 2023
CGM, Talisman, CE, Diabetes, Life, Classification, Electronics, Smartphone, Food, Medication, Pharmaceuticals and Medical Devices Agency, Data collection, Food and Drug Administration, Science, Blood, Development, CDMO, Documentation, In vitro, Miniaturization, Automation, PMDA, MHD, Algorithm, Engineering, Patient, Scientific Reports, FDA, Skin, Safety, Software, Medical device, Molex

"We wanted to create a solution that is needle free, accurate and more affordable so people would better monitor their glucose," said Jokke Mäki, managing director of GlucoModicum.

Key Points: 
  • "We wanted to create a solution that is needle free, accurate and more affordable so people would better monitor their glucose," said Jokke Mäki, managing director of GlucoModicum.
  • "Working with Phillips-Medisize, we applied compelling science to develop a world-class product that may help billions of people better manage their diabetes."
  • While their scientists conducted rigorous research, GlucoModicum sought an experienced contract development and manufacturing organization (CDMO) to assist in realizing their vision for a new device, called Talisman.
  • Together, the companies are also beginning to explore other potential uses of this innovative technology to support management of other diseases.

Ligand Appoints Martine Zimmermann to its Board of Directors

Retrieved on: 
Tuesday, September 26, 2023
Biotechnology, Health, Science, Pharmaceutical, Research, Doctor of Pharmacy, Drug development, Senior, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, AstraZeneca, EMA, Euronext Paris, Acquisition, PMDA, Louis Pasteur University, Regulatory affairs, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Medical device, Pharmacy, Ipsen

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced the appointment of Martine Zimmermann, PharmD, to its Board of Directors as an independent director.

Key Points: 
  • Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced the appointment of Martine Zimmermann, PharmD, to its Board of Directors as an independent director.
  • Dr. Zimmermann brings 25 years of global experience in the pharmaceutical industry to Ligand’s board.
  • “We are very pleased to welcome Martine to our board of directors.
  • Dr. Zimmermann received her Doctorate in Pharmacy (PharmD) with a specialty in immunology from the Louis Pasteur University, Strasbourg in France.

MEI Pharma Reports Fiscal Year 2023 Results and Operational Highlights

Retrieved on: 
Tuesday, September 26, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Workforce, Bevacizumab, Commercialization, Doctor of Philosophy, Lymphoid leukemia, Food, Medicines and Healthcare products Regulatory Agency, Calendar, Clinical trial, Cancer, OXPHOS, Aplastic anemia, Medication, Pharmaceuticals and Medical Devices Agency, Acute myeloid leukemia, PI3K, Kyowa Kirin, Development, VEGF, AML, BCL2, Glycolysis, Patient, Investment, PMDA, Colorectal cancer, Neoplasm, MEI, Research, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, CDK9, Venetoclax, Safety, Pharmaceutical industry, Cryptocurrency, Shareholder

MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its fiscal year ended June 30, 2023.

Key Points: 
  • MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its fiscal year ended June 30, 2023.
  • The certified results showed that 59.70% of outstanding shares were voted, of which 47.86% voted in favor of the proposed transaction, and 51.44% against.
  • In May 2023, MEI regained compliance with the Nasdaq minimum bid requirement after the Company implemented a 1-for-20 reverse stock split in April 2023.
  • As of June 30, 2023, MEI had $100.7 million in cash, cash equivalents, and short-term investments with no outstanding debt.

Weight-loss Programs Level Up With Smart Wearable Devices

Retrieved on: 
Friday, September 15, 2023
Sequence, CGM, Weight, Insurance, Planet Fitness, Diabetes, Garmin, Classification, Marketing, Obesity, Acquisition, Patient, Digital, Arrhythmia, News, NYSE, Financial News, Male, AMOLED, GRMN, Diet, Cael Sanderson, Smartphone, USD, Motivation, Apple, BMI, Mental health, Empowerment, Exercise, Human, WW International, National Health Service, Stroke, Sleep, Cancer, Pharmaceuticals and Medical Devices Agency, Mind, Zio, IRTC, Vital signs, PMDA, Blood, Heart rate, Hand, Blood pressure, White, Wrist, MHLW, Weight loss, Medication, Samsung, WW, Georgy Shonin, NMRD, Female, Mobile phone, Dietary supplement, Medical device, Birth control, Online shopping, Labour, Nemaura Medical, Health, Amazon

NEW YORK, Sept. 15, 2023 /PRNewswire/ -- The wearable technology market has evolved in recent years into a major tech segment, in large part thanks to consumer market growth which is driven by sales of smartwatches. Major companies like Apple and Samsung are heavily involved in the innovation of wearable devices, which are now capable of performing a wide range of features including cellular connectivity, health monitoring, contactless payment and more. Due to the advanced health monitoring features found in the devices, the wearable technology market is now playing an important role in the medical sector as well. In recent years, the devices have allowed healthcare providers to remotely monitor a patient's various physiological parameters. The most commonly measured data include vital signs such as heart rate, blood pressure, number of calories burned during a day, sleep quality and oxygen level in the blood. Nemaura Medical Inc. (NASDAQ: NMRD), Planet Fitness, Inc. (NYSE: PLNT), WW International, Inc. (NASDAQ: WW), Garmin Ltd. (NYSE: GRMN), iRhythm Technologies, Inc. (NASDAQ: IRTC)

Key Points: 
  • Due to the advanced health monitoring features found in the devices, the wearable technology market is now playing an important role in the medical sector as well.
  • In recent years, the devices have allowed healthcare providers to remotely monitor a patient's various physiological parameters.
  • Nemaura Medical Inc. (NASDAQ: NMRD) announced breaking news earlier this week regarding, "interim results from its metabolic health program.
  • The high medical needs designation in Japan is granted to innovative devices recognized as having high medical utility for significant diseases.