Society

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

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Thursday, March 28, 2024
Research, HNC, Symantec Endpoint Protection, Head, Type, Manganese, Chronic kidney disease, Incidence, ASN, CKD, New Drug Application, LAPC, Patient, Layoff, CRL, NDA, Cancer, Galera, Workforce, Pancreatic cancer, Clinical trial, Cisplatin, Society, Therapy, GRECO, File, Food, SOM, FDA, PDUFA, Pharmaceutical industry

We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.

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

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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.

Coave Therapeutics to Present at Upcoming Conferences

Retrieved on: 
Wednesday, March 27, 2024
Research, Congress, Gene, ARVO, Society, Cell

Paris, France, March 27, 2024 – Coave Therapeutics (‘Coave’), a genetic medicine company focused on developing life-changing therapies, announces that its management will be attending the following upcoming investor and industry conferences:

Key Points: 
  • Paris, France, March 27, 2024 – Coave Therapeutics (‘Coave’), a genetic medicine company focused on developing life-changing therapies, announces that its management will be attending the following upcoming investor and industry conferences:
    Cell & Gene Meeting on the Med – April 9-11 ; Rome, Italy
    LSX World Congress – April 29-30 ; London, UK
    BioEquity Europe – May 12-24 ; San Sebastián, Spain
    Gene Therapy Analytical Development Europe Summit - May 22-24 ; London, UK
    In addition, Coave’s scientific team will be present at the upcoming scientific, medical & regulatory conferences:
    ARVO (Association for Research in Vision and Ophthalmology) - May 5-6 ; Seattle, WA, US
    ASGCT (American Society of Gene and Cell Therapy) - May 7-11 ; Baltimore, MD, US

HeartFlow Initiates DECIDE Registry to Evaluate Utility of HeartFlow AI-Enabled Plaque Analysis for Patients with Suspected Coronary Artery Disease

Retrieved on: 
Tuesday, March 26, 2024
Nuclear, Education, Coronary artery disease, Disease, Safety, Partnership, Physiology, Anatomy, Patient, Journal, Biomarker, AI, Death, Plaque, Society, CAD, CCTA, Charleston Area Medical Center, MACE, Cone Health, Collection, FDA, Physician, IVUS, Hospital

The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).

Key Points: 
  • The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).
  • The DECODE study showed that clinicians using the HeartFlow Plaque Analysis changed their management decisions for 66% of patients compared to CCTA alone across various patient presentations and disease stages.
  • “We believe real-world prospective data from the new DECIDE Registry will empower clinicians with enhanced patient insights leveraging HeartFlow Plaque Analysis to improve patient outcomes.
  • The primary endpoint for this registry will highlight change in medical management after HeartFlow Plaque Analysis compared to after CCTA alone.

HeartSciences Announces Podium Presentation at World Congress of Anesthesiologists on the Utility of MyoVista® Wavelet ECG For Detection of Left Ventricular Diastolic Dysfunction in Preoperative Patients

Retrieved on: 
Tuesday, March 26, 2024
Diabetes, Disease, Echocardiography, HSCS, Congress, Algorithm, Intelligence, Anesthesia, Patient, Mortality, LVDD, Society, Anesthesiology, Type, Use, American Society of Echocardiography, Medical device

Preoperative left ventricular diastolic dysfunction (LVDD) is very common and one of the important causes of perioperative morbidity and mortality in cardiac and non-cardiac surgeries.

Key Points: 
  • Preoperative left ventricular diastolic dysfunction (LVDD) is very common and one of the important causes of perioperative morbidity and mortality in cardiac and non-cardiac surgeries.
  • In the study, patients undergoing preoperative anesthesia evaluation for cardiac and non-cardiac surgeries were enrolled.
  • For patients indicated for preoperative echocardiography, LVDD was diagnosed and graded as per American Society of Echocardiography (ASE) guidelines and a MyoVista wavECG was also performed.
  • Based on these findings, 25 of the 60 non-LVDD patients could be safely excluded from referral to preoperative echocardiography.

Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months

Retrieved on: 
Tuesday, March 26, 2024
Fracture, SABRE, Bone disease, Hip, Risk, Patient, Quality of life, BMD, Woman, Society, Osteoporosis, Ecosystem, PTH, FDA, Ageing, Food

The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.

Key Points: 
  • The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.
  • In November 2023 we issued a press release echoing ASBMR’s announcement that SABRE had submitted its final qualification package to FDA for the replacement of fracture as a regulatory endpoint.
  • Today we are thrilled to echo ASBMR’s announcement that FDA has set a concrete timetable to issue its ruling.
  • Fractures, particularly of the hip, are considered the most serious consequence of osteoporosis, which predominantly affects postmenopausal women and older men.

ACAMS’ "Financial Crime Matters" Podcast Leads the Charge in Unraveling Financial Crime Complexities, Reaching Milestone of 500,000+ Downloads

Retrieved on: 
Tuesday, March 26, 2024
ACAMS, AML, Business, Blockchain, Child, Interview, Society, Traction, District attorney, Folio, Illegal drug trade, AFC

WASHINGTON, D.C., March 26, 2024 (GLOBE NEWSWIRE) -- ACAMS’ acclaimed podcast series, "Financial Crime Matters," which is dedicated to exploring the intricate world of financial crime, has reached a significant milestone with over 500,000 downloads as of March 2024.

Key Points: 
  • WASHINGTON, D.C., March 26, 2024 (GLOBE NEWSWIRE) -- ACAMS’ acclaimed podcast series, "Financial Crime Matters," which is dedicated to exploring the intricate world of financial crime, has reached a significant milestone with over 500,000 downloads as of March 2024.
  • Launched in March 2019, the podcast has steadily gained traction among anti-financial crime (AFC) professionals and a broader audience interested in staying informed about illicit financial crime threats.
  • The inaugural episode of "Financial Crime Matters” featured Bradley Hope, co-author of the bestselling book "Billion Dollar Whale."
  • With an array of compelling episodes in the pipeline, "Financial Crime Matters" remains committed to fostering informed dialogue and empowering individuals with the knowledge to combat financial crime effectively.

Reviva to Present RECOVER Phase 3 Clinical Trial Data for Brilaroxazine in Schizophrenia at the ASCPT 2024 Annual Meeting

Retrieved on: 
Tuesday, March 26, 2024
Central nervous system, Poster, Annual general meeting, CNS, Society, CO

CUPERTINO, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will be presenting a poster at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2024 Annual Meeting, to be held in Colorado Springs, CO, USA on March 27-29, 2023.

Key Points: 
  • CUPERTINO, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will be presenting a poster at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2024 Annual Meeting, to be held in Colorado Springs, CO, USA on March 27-29, 2023.
  • Details for the presentation can be found below:

Portage Biotech Completes Monetization of Intensity Therapeutics (INTS) shares

Retrieved on: 
Tuesday, March 26, 2024
Immunotherapy, Society, Therapy, ASCO, SITC, PRTG, Intensity, Annual general meeting, Pharmaceutical industry

WESTPORT, Conn., March 26, 2024 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, today reported that it has completed selling its equity holding in Intensity Therapeutics (NASDAQ: INTS).

Key Points: 
  • WESTPORT, Conn., March 26, 2024 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, today reported that it has completed selling its equity holding in Intensity Therapeutics (NASDAQ: INTS).
  • Portage was an early INTS investor and during the past few months, Portage has been able to monetize its equity holdings in INTS and bring in proceeds, net of related expenses, totaling $2.8M of non-dilutive funding.
  • The Company will use the proceeds to further fund its PORT-6 Phase 1a portion of the ADPORT-601 trial.
  • “We are excited with the potential of the Company’s adenosine platform and are focusing our efforts on advancing its ADPORT-201 Phase 1a/1b clinical trial of PORT-6 (adenosine 2A inhibitor) and PORT-7 (adenosine 2B inhibitor) in selected solid tumors.”

Ocular Therapeutix™ To Present Data at the 2024 ASCRS Annual Meeting (American Society of Cataract and Refractive Surgery)

Retrieved on: 
Tuesday, March 26, 2024
Incidence, Ocular hypertension, Refractive surgery, ASCRS, Diabetic retinopathy, Patient, IRIS, Cataract, Quality of life, Eye, Society, Annual general meeting

BEDFORD, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, announced multiple scientific presentations at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting being held April 5-8 in Boston, Massachusetts.

Key Points: 
  • BEDFORD, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, announced multiple scientific presentations at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting being held April 5-8 in Boston, Massachusetts.
  • Title: Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: Results from a Phase 2 Clinical Trial
    Title: Incidence of Safety Events Following Cataract Surgery with Intracanalicular Dexamethasone: A Study of 50,000 Eyes Using the IRIS Registry
    Title: Characteristics of Cataract Surgery Patients Receiving Intracanalicular Dexamethasone Insert: An IRIS Registry Analysis of 50,000 Eyes