Diagnosis

Gamida Cell Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Wednesday, March 27, 2024
Capacity utilization, Diagnosis, Research, RSA, Bone marrow, TCT, Rituximab, Cell, General counsel, Health, Patient, EAP, Highbridge Capital Management, Society, Ronald Reagan, ATM, Depreciation, ID, Transplant, Therapy, Medicare, NK, CMS, Marketing, UCLA Health, Dentistry

BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Gamida Cell will become a private company, wholly owned by Highbridge, and the company’s outstanding ordinary shares are expected to be canceled.
  • The company has confirmed coverage with payers who cover more than 90% of commercial lives, exceeding the 2023 goal of 70%.
  • The full year Net Revenue included $1.1 million of net review for the fourth quarter of 2023.

Increased Adoption of Artificial Intelligence Across the Healthcare Industry Driving Strong Market Growth

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Wednesday, March 27, 2024
PWD, African Americans, Conditional sentence, Patient, Big data, Intellectual property, Lidar, Artificial intelligence, Certification, AMD, Risk, Sony, PALM, 3D, NIH, Treatment, Culture, Safety, OTCQB, CE marking, Weather, SSS, Prevalence, Radiology, Intelligence, Family, PLTR, Depth perception, Triage, News, Historical trauma, Cancer, AI, MDR, MPH, Butterfly, Health equity, Diagnosis, Arrhythmia, Health, Butterfly network, Growth, Patent, Perception, SNM, PTAB, AIP, FAAFP, FRCS, Medical device

In diagnostics, AI enables healthcare providers to make the most appropriate treatment decisions for their patients.

Key Points: 
  • In diagnostics, AI enables healthcare providers to make the most appropriate treatment decisions for their patients.
  • Mordor Intelligence continued: “The increased prevalence of cancer and the high burden of other chronic diseases are, in turn, increasing the demand for accurate diagnosis and treatment.
  • This is likely to increase the adoption of AI for early diagnosis purposes, ultimately boosting the market growth.
  • The use of artificial intelligence in the North American healthcare market is being driven by the increasing use of advanced technology in healthcare systems, the growth in funding of AI-based startups, the rising burden of chronic diseases in the country, the growing need to reduce healthcare costs, and the implementation of big data in healthcare.

Aeterna Zentaris Reports Fourth Quarter and Full Year 2023 Financial Results and Announces Completion of Enrollment in Ongoing Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency

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Wednesday, March 27, 2024
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TORONTO, ONTARIO, March 27, 2024 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today reported its financial and operating results for the year ended December 31, 2023 and provided an update on the completion of enrollment for its ongoing Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency ("CGHD").

Key Points: 
  • The Company completed enrollment of all patients in the DETECT-trial and expects that the last patient will receive the patient’s first growth hormone stimulation test using macimorelin in April 2024.
  • The study included approximately 100 subjects in Europe and North America.
  • Dr. Klaus Paulini, Chief Executive Officer of Aeterna commented, “With enrollment now completed in the DETECT-trial, we expect the completion of the DETECT-trial in the second quarter and Top-Line Data in the third quarter of this year.
  • The Company had $34.0 million in cash and cash equivalents at December 31, 2023.

EDAP Reports Fourth Quarter and Full-Year 2023 Financial Results

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Wednesday, March 27, 2024
AAGL, Patient, TMS, Investment, Endometriosis, Therapy, USD, Marketing, Congress, Urology, Teaching hospital, INPI, Food, Prostate cancer, EAU, Cancer, Hospital, Intellectual property, AUA, FDA, Diagnosis, DIE, Growth, EDAP, Operating cost, EDT, Randomized controlled trial

Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.

Key Points: 
  • Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.
  • The increase was driven by 10 Focal One systems sold in the fourth quarter of 2023 versus 7 systems sold in the fourth quarter of 2022.
  • Total revenue in the Distribution business for the fourth quarter of 2023 was EUR 9.9 million (USD 10.7 million), as compared to EUR 6.7 million (USD 7.0 million) for the fourth quarter of 2022.
  • Operating loss for the fourth quarter of 2023 was EUR 3.5 million (USD 3.8 million), compared to an operating loss of EUR 1.6 million (USD 1.6 million) in the fourth quarter of 2022.

Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA

Retrieved on: 
Wednesday, March 27, 2024
Diagnosis, NMPA, Patient, Ageing, NDA, Breakthrough, CDE, Duchenne muscular dystrophy, Therapy, Vamorolone, Safety, File, DMD, Neuromuscular disease, Pharmaceutical industry

Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.

Key Points: 
  • Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.
  • The Center for Drug Evaluation (CDE) of the Chinese drug authority NMPA accepted the filing and granted priority review for vamorolone in DMD for patients aged 4 years and older which could, subject to a positive outcome, lead to approval by Q1 2025.
  • Duchenne muscular dystrophy is a rare neuromuscular disease affecting about 70,000 patients in China.
  • The submission is further supported by a study which investigated the pharmacokinetic parameters of vamorolone in healthy adult Chinese volunteers.

World First Use of Lightpoint's SENSEI® Drop-In Gamma Probe in Bladder Cancer Surgery Performed in Spain

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Tuesday, March 26, 2024
Diagnosis, Biopsy, Sentinel lymph node, Radiation, Prostate cancer, Patient, ASX, SLN, Prostate, Bladder cancer, Hospital, TLX, Lymph node, Health technology, Medtech, AA, Medical imaging

SENSEI® is smaller than an AA battery and designed specifically for robotic-assisted and minimally invasive surgery.

Key Points: 
  • SENSEI® is smaller than an AA battery and designed specifically for robotic-assisted and minimally invasive surgery.
  • The miniature size and proprietary features make the technology ideal for tight surgical spaces such as around the bladder.
  • Radio-guided surgery has historically been limited by the fact that gamma probes are generally only suitable for open surgery.
  • Nynke van den Berg, General Manager Medical Technologies (MedTech) at Telix added, “A first bladder cancer procedure with the SENSEI® drop-in gamma probe is a significant milestone for Telix and the Lightpoint team.

AOFAS Awards More Than $250,000 in Grants to Fund Foot and Ankle Orthopaedic Research

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Tuesday, March 26, 2024
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Rosemont Ill., March 26, 2024 (GLOBE NEWSWIRE) -- The American Orthopaedic Foot & Ankle Society (AOFAS) awarded its annual research grants to 9 promising foot and ankle research projects.

Key Points: 
  • Rosemont Ill., March 26, 2024 (GLOBE NEWSWIRE) -- The American Orthopaedic Foot & Ankle Society (AOFAS) awarded its annual research grants to 9 promising foot and ankle research projects.
  • With funding from the Orthopaedic Foot & Ankle Foundation , the AOFAS Research Grants Program provides AOFAS members and their research teams with the resources to discover new foot and ankle treatments and advance patient care.
  • “The AOFAS Research Grants Program supports foot and ankle orthopaedic surgeons’ important work with basic, translational, and clinical science,” said AOFAS Research Committee Chair Jason T. Bariteau, MD, from Emory University in Atlanta.
  • The AOFAS Research Grants Program is funded by the Orthopaedic Foot & Ankle Foundation, supported in part by a grant from Arthrex, Inc.

Annexon Reports Fourth Quarter and Year-End 2023 Financial Results and Key Anticipated Milestones

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Tuesday, March 26, 2024
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BRISBANE, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress and reported fourth quarter and full year 2023 financial results.

Key Points: 
  • Finally, we anticipate clinical proof-of-concept data from our novel oral inhibitor ANX1502 later in the year.
  • ANX005 in GBS: First-in-class monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain.
  • ANX005 in GBS: Topline data from pivotal, randomized, placebo-controlled Phase 3 trial expected in the second quarter of 2024.
  • Cash and operating runway: Cash and cash equivalents and short-term investments were $259.7 million as of December 31, 2023.

Telomir Pharmaceuticals Announces Collaboration with Argenta to Study Osteoarthritis in Canines

Retrieved on: 
Friday, March 29, 2024
Diagnosis, B cell, Regeneration, TELO, Disease, Research, Nonsteroidal anti-inflammatory drug, MD, Quality of life, Human, Osteoarthritis, FDA, Ageing

BALTIMORE, March 26, 2024 (GLOBE NEWSWIRE) -- Telomir Pharmaceuticals, Inc. (Nasdaq:TELO) (“Telomir” or the “Company”), a pre-clinical-stage pharmaceutical company focused on the development and commercialization of Telomir-1 as the first novel small molecule to lengthen the DNA’s protective telomere caps in order to potentially address age-related conditions, today announced that Telomir and global animal health research company Argenta have agreed to begin a three to six-months study on the efficacy of Telomir-1 as a treatment for osteoarthritis and other diseases of aging in canines.

Key Points: 
  • The study will evaluate the efficacy of Telomir-1 for mitigating the progression of osteoarthritis based on symptomatic, radiographic, gross pathologic and histopathologic evaluations.
  • In addition, Telomir believes that this study could be used as part of its pre-clinicial program for eventually evaluating Telomir-1 in humans.
  • It is estimated that nearly 18 million canines in the United States are affected by osteoarthritis.
  • “Osteoarthritis is the most common ailment in canines yet there are currently no treatments that combat the disease.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, March 26, 2024
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“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.