Pharmaceuticals and Medical Devices Agency

Cara Therapeutics Reports First Quarter 2023 Financial Results

Retrieved on: 
Monday, May 15, 2023
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STAMFORD, Conn., May 15, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March 31, 2023.

Key Points: 
  • – Conference call today at 4:30 p.m. EDT –
    STAMFORD, Conn., May 15, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March 31, 2023.
  • “The U.S. and global launches of KORSUVA® (difelikefalin) injection / Kapruvia® gained momentum in the first quarter of 2023.
  • Wholesalers shipped 45,720 vials to dialysis centers, the majority of which were Fresenius clinics, during the first quarter of 2023.
  • Vial orders more than doubled quarter to quarter, signifying an acceleration in patient demand.

Catalyst Pharmaceuticals Reports Record First Quarter 2023 Results, Achieving 98% Total Revenue Growth Year-over-Year

Retrieved on: 
Wednesday, May 10, 2023
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Achieved Q1 2023 FIRDAPSE® net product revenue of $57.5 Million, representing a substantial 34% YoY increase.

Key Points: 
  • Achieved Q1 2023 FIRDAPSE® net product revenue of $57.5 Million, representing a substantial 34% YoY increase.
  • Research and Development Expenses: Research and development expenses in the first quarter of 2023 were $3.6 Million, compared to $3.4 Million in the first quarter of 2022.
  • Amortization of Intangible Assets: Amortization of intangible assets was $6.5 Million in the first quarter of 2023, compared to $0.00 in the first quarter of 2022.
  • 2023 Financial Guidance: The Company forecasts full-year 2023 total revenues, including FYCOMPA®, to be between $375 Million and $385 Million, representing a 75% - 80% increase in total revenues compared to 2022.

BioCardia Reports First Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, May 10, 2023
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SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission.

Key Points: 
  • SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission.
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • In March, positive echocardiography data from the trial was presented at the 2023 American College of Cardiology annual meeting in New Orleans.
  • First Quarter 2023 Financial Results:
    Revenues were approximately $64 thousand for the three months ended March 2023, compared to approximately $60 thousand for the three months ended March 2022.

Lisata Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 9, 2023
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BASKING RIDGE, N. J., May 09, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, provides a business update and reports financial results for the three months ended March 31, 2023.

Key Points: 
  • Conference call scheduled for today at 4:30 p.m. Eastern time
    BASKING RIDGE, N. J., May 09, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, provides a business update and reports financial results for the three months ended March 31, 2023.
  • LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies.
  • The combination of LSTA1 with corresponding standards-of-care in other solid tumor indications is planned for clinical study commencing before the end of the second quarter of 2023.
  • Lisata will hold a live conference call today, May 9, 2023, at 4:30 p.m. Eastern time to discuss financial results, provide a business update and answer questions.

Thorne HealthTech Wins 2023 MedTech Breakthrough Award for Best Overall Medical Device Product for Thorne's OneDraw® Blood Collection Device

Retrieved on: 
Wednesday, May 3, 2023
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NEW YORK, May 3, 2023 /PRNewswire/ -- Thorne HealthTech, Inc. ("Thorne") (NASDAQ: THRN), a leader in delivering innovative solutions for a personalized approach to health and wellness, announced today that its OneDraw® Blood Collection Device has been selected as the Best Overall Medical Device Product in the eighth annual MedTech Breakthrough Awards program.

Key Points: 
  • NEW YORK, May 3, 2023 /PRNewswire/ -- Thorne HealthTech, Inc. ("Thorne") (NASDAQ: THRN), a leader in delivering innovative solutions for a personalized approach to health and wellness, announced today that its OneDraw® Blood Collection Device has been selected as the Best Overall Medical Device Product in the eighth annual MedTech Breakthrough Awards program.
  • MedTech Breakthrough is an independent market intelligence organization that recognizes the "breakthrough" companies, individuals, platforms, and products in today's health, fitness, and medical technology industries.
  • Thorne's OneDraw Blood Collection Device is a single-use system that revolutionizes the collection, stabilization, and transport of whole blood samples, allowing for remote sample collection anytime and anywhere in a convenient and comfortable way.
  • "Thorne's OneDraw device is a true breakthrough in the medical device industry, and we are thrilled to recognize them as the Best Overall Medical Device Product in the 2023 MedTech Breakthrough Awards program," said James Johnson, Managing Director, MedTech Breakthrough.

An Introduction to the Medical Device Regulation Training Course: In-Depth Insight Into the European MDR Legislation - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 19, 2023
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She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Key Points: 
  • She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
  • Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.
  • Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK.
  • Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

electroCore Announces Remittance of Annual License Fee from Teijin for Certain Exclusive Rights in Japan

Retrieved on: 
Tuesday, April 11, 2023
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Under the license agreement, the Company received a non-refundable, upfront payment for the licenses and rights granted to Teijin.

Key Points: 
  • Under the license agreement, the Company received a non-refundable, upfront payment for the licenses and rights granted to Teijin.
  • Teijin’s exclusive rights are subject to a license fee payable on each anniversary of the license agreement until the first commercial sale in Japan on any approved indication.
  • By making the annual license fee payment, Teijin has extended its exclusive rights for another year.
  • As part of the license agreement, Teijin will have the right of first negotiation for a license to additional indications in Japan.

EDAP Announces Regulatory Clearance of ExactVu Micro-Ultrasound in Japan

Retrieved on: 
Thursday, April 6, 2023
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LYON, France, April 6, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today provided a regulatory and clinical update. The Company has received approval from the Pharmaceutical and Medical Devices Agency (“PMDA”) for the commercialization of the ExactVu™ micro-ultrasound biopsy platform in Japan.

Key Points: 
  • LYON, France, April 6, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today provided a regulatory and clinical update.
  • The Company has received approval from the Pharmaceutical and Medical Devices Agency (“PMDA”) for the commercialization of the ExactVu™ micro-ultrasound biopsy platform in Japan.
  • “We are pleased to announce the approval of the ExactVu system in Japan,” said Marc Oczachowski, Chief Executive Officer and Chairman of the Board of EDAP TMS.
  • ExactVu™ is already available for sale in the European Union (CE Mark), the United States (FDA 510(k) clearance), and in Canada (Health Canada license).

Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published

Retrieved on: 
Tuesday, April 4, 2023
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A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.

Key Points: 
  • A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
  • This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
  • The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
  • The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published

Retrieved on: 
Tuesday, April 4, 2023
Priority review, Plaque, CET, MHLW, Marketing, Advisory Committee, Memantine, Food, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Clinical trial, Quality of life, Ministry of Health, Labour and Welfare, Brain, Alzheimer's disease, SOC, MCI, Medication, Pharmaceuticals and Medical Devices Agency, Advisory Committee on Immunization Practices, EMA, Clarity, Ministry, Eisai, Prescription Drug User Fee Act, HIV disease progression rates, Patient, Standard of care, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), Neurology, MAA, AD, FDA, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Caregiver, Safety, Pharmaceutical industry, Biogen, Health

A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.

Key Points: 
  • A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
  • This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
  • The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
  • The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.