Mortality

Seres Therapeutics Announces Completion of Patient Enrollment for SER-155 Phase 1B Cohort 2 Clinical Trial in Allogenic HSCT

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Disease, Allo, Infection, Incidence, Patient, Immune tolerance, Gastrointestinal tract, GI, David Berry (inventor), Mortality, Bacteria, HSCT, Bloodstream infections, Graft-versus-host disease, Therapy, Chronic liver disease, Safety, Immunodeficiency, Data, Pharmaceutical industry

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its Phase 1b trial of SER-155 in patients who received Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its Phase 1b trial of SER-155 in patients who received Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT).
  • Infections are a leading cause of mortality and morbidity in this immunocompromised patient population.
  • Our pending clinical results could validate the promise of microbiome therapeutics to prevent poor outcomes associated with pathogens in the GI tract.
  • Study Cohort 2, which includes 45 participants, incorporates a randomized, double-blinded placebo-controlled 1:1 design to further evaluate safety and engraftment, as well as clinical outcomes.

Launch of two first-in-class medicines in 2023 marks start of exciting phase of growth for Ferring

Retrieved on: 
Tuesday, April 9, 2024
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, CER, Nadofaragene firadenovec, AER, Audit, Growth, Alexandra, Countess of Frederiksborg, Ferring, Falk, Partnership, ESG, Mortality, Nordic Investment Bank, PPH, Committee on Finance, Annual report, Count, Vice, Food, Management

EBITDA increased by +€43 million (+12% at AER) to reach €406 million and operating profit for the year reached €139 million.

Key Points: 
  • EBITDA increased by +€43 million (+12% at AER) to reach €406 million and operating profit for the year reached €139 million.
  • The year marked a major turning-point for Ferring with the launch of two innovative first-in-class medicines in the United States.
  • Ferring is evolving to make the most of these opportunities, and there were a number of significant changes to the senior leadership.
  • Jean-Frédéric Paulsen, Chairman of the Board of Directors, said: “The launch of two groundbreaking medicines in the US, along with the other important changes in 2023, mark the start of an exciting new phase of growth for Ferring.

United States Cardiovascular Devices Market, Size, Share, Forecast 2024-2030 Featuring Abbott Laboratories, Boston Scientific, Edwards Lifesciences, Cardinal Health, Medtronic, GE, J&J, & Siemens - ResearchAndMarkets.com

Retrieved on: 
Monday, April 8, 2024
Health, Medical Devices, Cardiology, Hospital, Cardiac catheterization, Disease, American Heart Association, Stent, Cardiovascular disease, Coronary artery disease, Prevalence, Biotechnology, CVD, ECG, Incidence, Diabetes, Electrocardiography, Public, Research, Mortality, Insight, Death, Risk, Arrhythmia, Diagnosis, Heart failure, CAD, Medical device

Consequently, producers are investing in innovation and developing new cardiovascular devices to satisfy growing healthcare wishes, expanding the increase in the United States cardiovascular devices market.

Key Points: 
  • Consequently, producers are investing in innovation and developing new cardiovascular devices to satisfy growing healthcare wishes, expanding the increase in the United States cardiovascular devices market.
  • Technology is pivotal in employing growth in the United States cardiovascular devices market.
  • Numerous market players actively enforce strategic tasks, propelling an increase in the United States cardiovascular devices market.
  • In the United States cardiovascular devices market, diagnostics and monitoring devices have a significant presence
    The United States cardiovascular device market is broken up by device type into Diagnostics and Monitoring Devices and Therapeutic and Surgical Devices.

FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose

Retrieved on: 
Monday, April 8, 2024
General Health, FDA, Health, Pharmaceutical, Medical Supplies, Hypoventilation, Hypersensitivity, Nalmefene, Pulmonary edema, Caregiver, Safety, Tachycardia, Risk, New Drug Application, Patient, Ventricular tachycardia, Naloxone, Health care, Buprenorphine, Mortality, NDA, MD, Methadone, Ventricular fibrillation, Hypotension, Oxygen, LAAM, Recurrence, Allergy, Purdue University, Hypertension, Fentanyl, Pharmaceutical industry

Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.

Key Points: 
  • Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.
  • "Through this auto-injector FDA submission, our goal is to help expand the availability of nalmefene to the community alongside existing available options for healthcare professionals.
  • Priority review status means that FDA will expedite the review process to evaluate a drug that would significantly improve treatment of a serious condition.
  • Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

Surgical Safety Technologies joins Wellcome Leap's SAVE Program to Shorten MD Surgeon Training Time, Certify non-MD Practitioners Worldwide

Retrieved on: 
Tuesday, April 9, 2024
Certification, Partnership, Patient, Hospital, Research, Mortality, Acquisition, AI, MD, Risk, Surgeon, Workforce, Patient safety, Disability, LOS, SAVE, Artificial intelligence, Virtual reality, Medical device

NEW YORK and LOS ANGELES, April 9, 2024 /PRNewswire/ -- Surgical Safety Technologies, a pioneer in AI-enhanced surgical quality and safety improvement, today announced their participation in Wellcome Leap's SAVE (Surgery: Assess / Validate / Expand) program. As a SAVE performer, Surgical Safety Technologies will provide its OR Black Box® Platform to researchers and academics working to create and deploy new models for minimally invasive abdominal surgery skills acquisition and objective assessment, and produce new patient recovery and deterioration detection systems. The team of performers will measure the impact of this program on surgical procedure access and outcomes around the world.

Key Points: 
  • NEW YORK and LOS ANGELES, April 9, 2024 /PRNewswire/ -- Surgical Safety Technologies , a pioneer in AI-enhanced surgical quality and safety improvement, today announced their participation in Wellcome Leap's SAVE (Surgery: Assess / Validate / Expand) program.
  • The team of performers will measure the impact of this program on surgical procedure access and outcomes around the world.
  • The SAVE program aims to develop new technologies combining AI, visualization and simulation to accomplish three major goals: 1.
  • The integration of Surgical Safety Technologies' platform into surgical training has demonstrated its immense potential to enhance patient safety and democratize access to high-quality care.

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024
Neurology, Neuroprotection, Element, Conference call, Institutional review board, Cerebrospinal fluid, Survival, Disease, ALS, SPA, Bone marrow, CSF, Data monitoring committee, Webcast, Patient, Protocol, Biomarker, Mortality, Microsoft Exchange Server, Stem cell, DMC, Screening, Agency, Safety, CAFS, Brainstorm, Therapy, Marketing, FDA, BLA, Neuroinflammation, Food, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants

Retrieved on: 
Monday, April 8, 2024
Failure, De novo, Health, Prevalence, Infection, Arthroplasty, Patient, Trauma, Mortality, Bacteria, Osteoporosis, Food and Drug Administration, Neoplasm, Amputation, FDA, Onko, Pharmaceutical industry

PARSIPPANY, N.J., April 8, 2024 /PRNewswire/ -- Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a De Novo approval for its novel antibacterial coated implants. Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.

Key Points: 
  • PARSIPPANY, N.J., April 8, 2024 /PRNewswire/ -- Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a De Novo approval for its novel antibacterial coated implants.
  • Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.
  • "Implant contamination is a growing concern to the orthopaedic surgical community," said Steven Gitelis, MD, Onkos Surgical Chief Medical Officer, Rush Medical College, Endowed Professor of Orthopaedic Oncology and Director, Musculoskeletal Oncology at Rush Cancer Center.
  • The Onkos technology is a significant innovation and another option to help reduce local bacterial load on the implant."

All-Star Athlete Brand Coco5 Partners with American Cancer Society & Coaches vs Cancer To Fuel The Fight Against Cancer

Retrieved on: 
Monday, April 8, 2024
Partnership, Patient, American Cancer Society, Research, Mortality, Hope, Athlete, NABC, National Association, NBA, Pharmaceutical industry

PHOENIX, April 8, 2024 /PRNewswire/ -- Athlete-founded beverage brand Coco5 is excited to announce the launch of Fuel The Fight, an impactful partnership with the American Cancer Society and Coaches vs. Cancer. The multi-year initiative supports the American Cancer Society's vision to end cancer as we know it, focusing on raising funds for innovative cancer research and encouraging prevention and early detection to improve mortality rates from cancer.

Key Points: 
  • PHOENIX, April 8, 2024 /PRNewswire/ -- Athlete-founded beverage brand Coco5 is excited to announce the launch of Fuel The Fight, an impactful partnership with the American Cancer Society and Coaches vs. Cancer .
  • The partnership invites fans to play a pivotal role in helping fuel the fight against cancer, which affects millions of people annually.
  • "I've seen firsthand how partnerships transform our fight against cancer," shares Coach Lon Kruger, council chair of Coaches vs. Cancer.
  • "At the American Cancer Society, we recognize that our vision to end cancer as we know it isn't something we can do ourselves," remarks Brant Woodward Senior Executive Vice President of Field Operations for the American Cancer Society.

Association of Black Cardiologists' "We Are The Faces" Campaign Unveils New Videos for Black Maternal Health Week

Retrieved on: 
Saturday, April 6, 2024
Mother, Disease, Health, ABC, Cardiovascular disease, Cardiology, Patient, Mortality, Pregnancy, Spouse, Collection, Obstetrics

WASHINGTON, April 6, 2024 /PRNewswire/ -- In celebration of Black Maternal Health Week (April 11-17, 2024) and April's Minority Health Month, the Association of Black Cardiologists (ABC) is proud to unveil a new slate of videos as part of its third year of the "We Are The Faces of Black Maternal Health" awareness and advocacy campaign.

Key Points: 
  • WASHINGTON, April 6, 2024 /PRNewswire/ -- In celebration of Black Maternal Health Week (April 11-17, 2024) and April's Minority Health Month, the Association of Black Cardiologists (ABC) is proud to unveil a new slate of videos as part of its third year of the "We Are The Faces of Black Maternal Health" awareness and advocacy campaign.
  • This series amplifies the intergenerational impact of the Black maternal health crisis and underscores the critical role of healthcare professionals in addressing racial disparities in maternal health outcomes.
  • ABC members are uniquely positioned to address the maternal health crisis, given the intersection of maternal health and cardiovascular well-being.
  • Together, we can effect tangible change and rewrite the narrative on Black maternal health.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.