Pharmaceuticals and Medical Devices Agency

BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, November 8, 2023
FDA, Research, Security (finance), N-terminal prohormone of brain natriuretic peptide, Heart failure, Arrest, Heart, Therapy, Facial muscles, Medicare, Microsoft Exchange Server, Mortality, Data, BCDA, Pharmaceuticals and Medical Devices Agency, Maintenance, Ischemia, Phase, Quality of life, Data monitoring committee, PMDA, LVAD, Clinical trial, Risk, Marketing, III, Safety, Trial of the century, Patient, DSMB, Pharmaceutical industry, Medical device, Cryptocurrency, Helix

The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.

Key Points: 
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • During the third quarter of 2023, BioCardia worked with the DSMB to unblind a small committee within the Company to review the closed session DSMB report of interim study results to better understand the rationale behind their recommendation.
  • The Company expects to complete the roll-in cohort of patients in the fourth quarter of 2023 and begin the randomized phase of the trial.
  • Third Quarter 2023 Financial Results:
    Revenues were approximately $357,000 for the three months ended September 2023, compared to approximately $212,000 for the three months ended September 2022.

EQS-News: CHEPLAPHARM opens presence in Tokyo

Retrieved on: 
Tuesday, November 7, 2023
United States federal executive departments, Marketing authorisation, Dean, Cheplapharm Arzneimittel, Medication, Toronto Metropolitan University, Business development, Medicines and Healthcare products Regulatory Agency, Ministry, Ministry of Health, Labour and Welfare, Business administration, Marketing, Business, Strategic planning, Temple, Aerospace engineering, Patient, Pharmaceuticals and Medical Devices Agency, Pharmaceutical industry, Novartis, Health

CHEPLAPHARM Arzneimittel GmbH, based in Greifswald/Germany, has opened a presence in the Japanese capital Tokyo and obtained the pharmaceutical licence for Japan.

Key Points: 
  • CHEPLAPHARM Arzneimittel GmbH, based in Greifswald/Germany, has opened a presence in the Japanese capital Tokyo and obtained the pharmaceutical licence for Japan.
  • The managing director of the founded CHEPLAPHARM KK is Kentaro Ichimori, who most recently held a leading position for Sandoz in Japan.
  • Establishing a presence in Japan and launching CHEPLAPHARM as a local brand is important to further build trust with local business partners, doctors and patients.
  • The opening of an office in Tokyo and the presence on the Japanese market serves to establish CHEPLAPHARM as a brand in Japan and make it better known, thus leveraging further growth potential.

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.

REPROCELL Announces License Agreement with Gameto for the Advancement of its Program to Improve Assisted Fertility using iPSCs

Retrieved on: 
Wednesday, October 4, 2023
GMP, IPSC, Oocyte, Biotechnology, Medicines and Healthcare products Regulatory Agency, IVF, European Medicines Agency, Patient, Cell engineering, Health, Woman, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceuticals and Medical Devices Agency, Pharmaceutical industry

NEW YORK, Oct. 4, 2023 /PRNewswire/ -- REPROCELL Inc. today announced that it has entered into an agreement to grant Gameto Inc., a female-led biotechnology company with a mission to redefine women's healthcare, a non-exclusive right to use REPROCELL's StemRNA™ Clinical Seed iPSCs. The clinical-grade iPSC line will be used for the development and commercialization of Gameto's program to improve the IVF and egg freezing process, Fertilo. Terms of the agreement were not disclosed.

Key Points: 
  • Gameto plans to use the iPSC line to advance its program, Fertilo, designed to improve IVF and egg freezing.
  • The clinical-grade iPSC line will be used for the development and commercialization of Gameto's program to improve the IVF and egg freezing process, Fertilo.
  • "We are thrilled to partner with Gameto to enable and support their program, Fertilo.
  • "Women using these current services are still subject to dozens of hormonal injections and the associated side effects and complications.

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.

InterVenn Biosciences Welcomes Accomplished Diagnostics Executive Joshua Stahl as CEO

Retrieved on: 
Wednesday, September 27, 2023
Science, Other Science, Biotechnology, Research, General Health, Health, Technology, Other Technology, Interim, NGS, Medicines and Healthcare products Regulatory Agency, Liquid biopsy, Carolyn Bertozzi, Multimedia, Medication, Pharmaceuticals and Medical Devices Agency, RUO, Acquisition, Patient, IVD, Growth, Management, Medical imaging, Oncology, Archery

InterVenn Biosciences , the life sciences company pioneering glycoproteomic-based diagnostics, today announced that Joshua Stahl has been appointed as Chief Executive Officer to guide the company’s next phase of commercial growth.

Key Points: 
  • InterVenn Biosciences , the life sciences company pioneering glycoproteomic-based diagnostics, today announced that Joshua Stahl has been appointed as Chief Executive Officer to guide the company’s next phase of commercial growth.
  • View the full release here: https://www.businesswire.com/news/home/20230927452734/en/
    Joshua Stahl has been appointed as Chief Executive Officer to guide InterVenn's next phase of commercial growth.
  • (Photo: Business Wire)
    Mr. Stahl has a proven track record of building successful diagnostics companies.
  • Throughout his tenure, Mr. Stahl held leadership roles with increasing responsibility before becoming Chief Scientific Officer and Chief Operating Officer.

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.

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.