PDMA

Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for the Indication of Amyotrophic Lateral Sclerosis

Retrieved on: 
Friday, January 26, 2024
Principal, ALS, Research, University of Tokushima, Biomedical sciences, Patient, Safety, Respiratory failure, Ministry, Neurodegenerative disease, Paralysis, Disease, MHLW, JAMA Neurology, Agonal respiration, Death, Eisai, Medication, PDMA, Muscle atrophy, NDA, Pharmaceutical industry

TOKYO, Jan 26, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan.

Key Points: 
  • TOKYO, Jan 26, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan.
  • In May 2022, ultrahigh-dose mecobalamin received orphan drug designation by the Ministry of Health, Labour and Welfare (MHLW).
  • The results of JETALS were published in the peer-reviewed journal JAMA Neurology.
  • ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction.

Sopheon Customers Win Three Straight Outstanding Corporate Innovator Awards

Retrieved on: 
Wednesday, September 6, 2023
PDMA, Creativity, Organization, OCI, Product Development and Management Association, Corporation, Management, Sopheon

PITTSBURGH, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Sopheon , the InnovationOps software company, announced that its customers have won the Outstanding Corporate Innovator (OCI) Award for three consecutive years.

Key Points: 
  • PITTSBURGH, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Sopheon , the InnovationOps software company, announced that its customers have won the Outstanding Corporate Innovator (OCI) Award for three consecutive years.
  • “Sopheon is proud to work alongside many of the most innovative companies in the world,” said Greg Coticchia, CEO of Sopheon.
  • Sopheon enables a perfect combination of creativity and structure that allows companies to respond to market needs in real time.
  • To learn more about how Sopheon empowers executives, leaders and team members involved with innovation and product development to embrace change, visit our website at www.sopheon.com .

Cadrenal Therapeutics Announces Appointment of Robert Lisicki to Board of Directors

Retrieved on: 
Monday, July 24, 2023
Inflammation, PDMA, Amgen, BS, Sabine Lisicki, Therapy, State University of New York, Arena Pharmaceuticals, Compensation, State university system, EMA, Economics, Acquisition, Immunology, Regeneron Pharmaceuticals, FDA, Pfizer, Pharmaceutical industry, Pain, Circulatory system

PONTE VEDRA, Fla., July 24, 2023 /PRNewswire/ -- Cadrenal Therapeutics, Inc., ("Cadrenal" or the "Company") (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) for certain rare medical conditions, today announced the appointment of Robert Lisicki to its Board of Directors and Compensation and Nomination/Governance Committees.

Key Points: 
  • PONTE VEDRA, Fla., July 24, 2023 /PRNewswire/ -- Cadrenal Therapeutics, Inc., ("Cadrenal" or the "Company") (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) for certain rare medical conditions, today announced the appointment of Robert Lisicki to its Board of Directors and Compensation and Nomination/Governance Committees.
  • "I look forward to leaning on his executive experience and commercial vision as a member of the Cadrenal board."
  • "I believe Cadrenal Therapeutics is developing a novel and potentially paradigm-changing therapeutic," said Robert Lisicki.
  • Lisicki will occupy a newly created seat on the Cadrenal Board of Directors.

Scivita Medical's 4K UHD Fluorescence Imaging System showcased at EAES 2023

Retrieved on: 
Wednesday, June 21, 2023
PDMA, Single, International, CET, Exhibition, UHD, Endoscopy, Gynaecology, Patient, 3D film, European Association of Urology, International Congress on Tuberculosis, Elective surgery, Urology, D, Medical device, Fluorescence

Medical technology company Scivita Medical attended EAES 2023 and showcased its 4K UHD Fluorescence Imaging System, 3D Visualization System (Booth: E36), which reflects Scivita Medical's determination to its core strategy of "globalization".

Key Points: 
  • Medical technology company Scivita Medical attended EAES 2023 and showcased its 4K UHD Fluorescence Imaging System, 3D Visualization System (Booth: E36), which reflects Scivita Medical's determination to its core strategy of "globalization".
  • With solid in-house R&D capabilities, Scivita Medical has built a unique technology platform based on five synergistic core technologies: 4K UHD medical imaging technology, Fluorescence medical imaging technology, 3D medical imaging technology, Ultrathin Endoscopic imaging technology and Single-use Endoscopic technology.
  • The 4K UHD Fluorescence Imaging System exhibited at EAES 2023 is developed by 4K UHD medical imaging technology and Fluorescence medical imaging technology from this unique technology platform.
  • Scivita Medical 4K UHD Fluorescence combined with 3D Technology to obtain ultra-high-definition 3D images with fluorescence effect, which can be used in hepatobiliary surgery, thoracic surgery, gynecology, gastrointestinal surgery, and urology, etc.

Scivita Medical's Headquarters, R&D and Manufacturing Plant Officially Opened

Retrieved on: 
Friday, June 2, 2023
PDMA, Heart, CE, Male, Marketing, Nigerian Investment Promotion Commission, CPC, Committee, Endoscopy, USD, Female, Metro Orlando Economic Development Commission, Patient, SIP, Suzhou Industrial Park, Growth, Lishan Constructing Administrative Bureau, R, FDA, Investment, D, Medical device, Science

SUZHOU, China, June 2, 2023 /PRNewswire/ -- On June 2, 2023 (Beijing Time), Scivita Medical's headquarters, R&D and manufacturing plant was officially opened in Suzhou Industrial Park (SIP).

Key Points: 
  • SUZHOU, China, June 2, 2023 /PRNewswire/ -- On June 2, 2023 (Beijing Time), Scivita Medical's headquarters, R&D and manufacturing plant was officially opened in Suzhou Industrial Park (SIP).
  • Dr Chin To, Scivita Medical's co-founder, General Manager, Chief Technology Officer, said: "The newly established headquarters, R&D and manufacturing plant is a significant milestone in Scivita Medical's journey, and it will play a big part in enhancing the comprehensive strength of Scivita Medical in all aspects.
  • Over the years, Scivita Medical's endoscopes have acquired the competitive edge required to thrive in the global market.
  • The official opening of Scivita Medical's headquarters, R&D and manufacturing plant will further strengthen its comprehensive capabilities in innovation, R&D, and production on a global scale.

Scivita Medical's Headquarters, R&D and Manufacturing Plant Officially Opened

Retrieved on: 
Friday, June 2, 2023
PDMA, Heart, CE, Male, Marketing, Nigerian Investment Promotion Commission, CPC, Committee, Endoscopy, USD, Female, Metro Orlando Economic Development Commission, Patient, SIP, Suzhou Industrial Park, Growth, Lishan Constructing Administrative Bureau, R, FDA, Investment, D, Medical device, Science

SUZHOU, China, June 2, 2023 /PRNewswire/ -- On June 2, 2023 (Beijing Time), Scivita Medical's headquarters, R&D and manufacturing plant was officially opened in Suzhou Industrial Park (SIP).

Key Points: 
  • SUZHOU, China, June 2, 2023 /PRNewswire/ -- On June 2, 2023 (Beijing Time), Scivita Medical's headquarters, R&D and manufacturing plant was officially opened in Suzhou Industrial Park (SIP).
  • Dr Chin To, Scivita Medical's co-founder, General Manager, Chief Technology Officer, said: "The newly established headquarters, R&D and manufacturing plant is a significant milestone in Scivita Medical's journey, and it will play a big part in enhancing the comprehensive strength of Scivita Medical in all aspects.
  • Over the years, Scivita Medical's endoscopes have acquired the competitive edge required to thrive in the global market.
  • The official opening of Scivita Medical's headquarters, R&D and manufacturing plant will further strengthen its comprehensive capabilities in innovation, R&D, and production on a global scale.

PCI Pharma Services Announces New Sterile Fill-Finish Capabilities Now Available in Melbourne and San Diego

Retrieved on: 
Tuesday, April 18, 2023
Pharmaceutical, Medical Supplies, Health, Packaging, Medical Devices, Supply Chain Management, Manufacturing, Retail, PDMA, ANVISA, Clinical trial, Multimedia, PCI, CDMO, Patient, III, Glass, Automation, Syringe, Pharmaceutical industry

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational.

Key Points: 
  • PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational.
  • The innovative machinery from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs.
  • The equipment, paired with PCI’s end-to-end services, accelerates Speed to Study™, and drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution.
  • View the full release here: https://www.businesswire.com/news/home/20230418005121/en/
    The Microcell Vial Filler in action at PCI’s San Diego location.

MEDICA 2022 Newcomer: Scivita Medical celebrates trade show success and the strategy of "globalization"

Retrieved on: 
Monday, November 21, 2022
Medicine, Innovation, Endoscopy, FDA, UHD, Women & Infants Hospital of Rhode Island, International, Fujifilm, Medtech, Research, Patient, PDMA, Single, COVID-19, European, Hospital, MEDICA, Child, Product life-cycle theory, Diagnosis, Collaborative innovation network, Medical device

DUSSELDORF, Germany, Nov. 20, 2022 /PRNewswire/ -- Medical technology company Scivita Medical Technology Co., Ltd. ("Scivita Medical") looks back on an exciting week at the trade fair.

Key Points: 
  • DUSSELDORF, Germany, Nov. 20, 2022 /PRNewswire/ -- Medical technology company Scivita Medical Technology Co., Ltd. ("Scivita Medical") looks back on an exciting week at the trade fair.
  • Scivita Medical is a global medical technology company for minimally invasive diagnostic, establishing R&D centers in both China and Japan.
  • Besides, Scivita Medical has obtained FDA-/CE- and PDMA-certifications for their products and applied patents in China as well as overseas.
  • Driven by the goal of integrating research and development in medical technology, Scivita Medical is cooperating with many clinics and medical centers.

MEDICA 2022 Newcomer: Scivita Medical celebrates trade show success and the strategy of "globalization"

Retrieved on: 
Monday, November 21, 2022
Medicine, Innovation, Endoscopy, FDA, UHD, Women & Infants Hospital of Rhode Island, International, Fujifilm, Medtech, Research, Patient, PDMA, Single, COVID-19, European, Hospital, MEDICA, Child, Product life-cycle theory, Diagnosis, Collaborative innovation network, Medical device

DUSSELDORF, Germany, Nov. 21, 2022 /PRNewswire/ -- Medical technology company Scivita Medical Technology Co., Ltd. ("Scivita Medical") looks back on an exciting week at the trade fair.

Key Points: 
  • DUSSELDORF, Germany, Nov. 21, 2022 /PRNewswire/ -- Medical technology company Scivita Medical Technology Co., Ltd. ("Scivita Medical") looks back on an exciting week at the trade fair.
  • Scivita Medical is a global medical technology company for minimally invasive diagnostic, establishing R&D centers in both China and Japan.
  • Besides, Scivita Medical has obtained FDA-/CE- and PDMA-certifications for their products and applied patents in China as well as overseas.
  • Driven by the goal of integrating research and development in medical technology, Scivita Medical is cooperating with many clinics and medical centers.

US WorldMeds to Deploy StayinFront TouchRx CRM

Retrieved on: 
Tuesday, June 28, 2022
Efficiency, Patient, List of life sciences, Event management, HCPS, Research, GLOBE, Pharma, Associate Director of National Intelligence and Chief Information Officer, PDMA, Goal, Compliance, CLM, United Kingdom, Partnership, Information technology, Technology, Licensure, Federal, Solution, Time, USWM, Mobile, CRM, Fine chemical, Biotechnology

StayinFront will provide its advanced mobile solution, StayinFront TouchRx , to US WorldMeds field representatives to maximize their efficiency and effectiveness.

Key Points: 
  • StayinFront will provide its advanced mobile solution, StayinFront TouchRx , to US WorldMeds field representatives to maximize their efficiency and effectiveness.
  • StayinFront TouchRx is supported by a highly experienced team that has worked with Life Science companies for over 20 years.
  • StayinFront TouchRx, delivers an intuitive interface that empowers field teams and mangers, said Ken Arbadji, Vice President Sales, North America at StayinFront.
  • Pharma and Biotech companies rely on StayinFront to optimize field team performance and streamline sales operations by reducing the complexity, time, and costs of CRM.