The New England Journal of Medicine

European Commission Approves Pfizer’s ABRYSVO™ to Help Protect Infants through Maternal Immunization and Older Adults from RSV

Retrieved on: 
Thursday, August 24, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Inc., Pregnancy, Senior, Civil service commission, Public, The New England Journal of Medicine, PFE, European Directive on Traditional Herbal Medicinal Products, Respiratory syncytial virus, Committee, Development, Death, RSV, Committee for Medicinal Products for Human Use, Research, Immunization, EC, Safety, NYSE, European Commission, CHMP, Vaccine, EU, Pfizer

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunization and older adults.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunization and older adults.
  • “Last year’s significant number of newborns, children, and adults being hospitalized across Europe demonstrated the immense need for protection against severe RSV cases.
  • RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.
  • Each year, the virus causes more than 270,000 hospitalizations and about 20,000 deaths in individuals 60 years and older.7

Positive Phase 1/2 Clinical Trial Results of Genethon’s Gene Therapy for Crigler-Najjar Syndrome, a Rare Liver Disease, Published in The New England Journal of Medicine

Retrieved on: 
Tuesday, August 22, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Haemophilia, DSM-IV codes, PI, Nerve, The New England Journal of Medicine, Clinical trial, Quality of life, Crigler–Najjar syndrome, Academic Medical Center (Amsterdam), Research, Creativity, Light, Jaundice, Bilirubin, UGT1A1, Liver, Ageing, Safety, Jeanne Labrune, Pharmaceutical industry, Patient

Genethon, a pioneer and leader in gene therapy research and development for rare genetic diseases, announced today positive Phase 1/2 clinical trial results of its gene therapy, GNT-0003, for Crigler-Najjar syndrome were published in The New England Journal of Medicine.

Key Points: 
  • Genethon, a pioneer and leader in gene therapy research and development for rare genetic diseases, announced today positive Phase 1/2 clinical trial results of its gene therapy, GNT-0003, for Crigler-Najjar syndrome were published in The New England Journal of Medicine.
  • The data demonstrate the possibility of restoring expression of liver enzyme UGT1A1 by using gene therapy in cases of Crigler-Najjar syndrome.
  • The Phase 1/2 trial results published in an article titled, “Gene Therapy in Patients with the Crigler-Najjar Syndrome,” showed GNT-0003 lowered bilirubin levels below the toxic threshold with a single intravenous injection.
  • This is the first proof of the efficacy of a gene therapy in a metabolic disease of the liver.

Mainz Biomed Announces Live Launch of ColoAlert® with testDNA Laboratory in Poland

Retrieved on: 
Tuesday, August 22, 2023
Polish Center for Holocaust Research, The New England Journal of Medicine, Partnership, CRC, Cancer, Research, World Cancer Research Fund International, Collection, Risk, Colorectal cancer, Colonoscopy, Accreditation, Mortality, Ageing, Pharmaceutical industry

BERKELEY, Calif. and MAINZ, Germany, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces the commercial launch of ColoAlert® in Poland, made possible through a strategic collaboration with testDNA Sp.

Key Points: 
  • BERKELEY, Calif. and MAINZ, Germany, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces the commercial launch of ColoAlert® in Poland, made possible through a strategic collaboration with testDNA Sp.
  • The partnership marks another significant step forward in providing new and innovative testing options to underserved populations in the battle against colorectal cancer (“CRC”).
  • As an accredited research laboratory sanctioned by the Polish Center for Accreditation, the laboratory is headquartered in Katowice, Poland, and boasts an expansive network of over 300 collection points throughout the country.
  • Together, we are well positioned to help transform and improve the current cancer screening options in Poland and provide timely interventions that have the potential to save lives."

EQS-News: Mainz Biomed Announces Live Launch of ColoAlert® with testDNA Laboratory in Poland

Retrieved on: 
Tuesday, August 22, 2023
Polish Center for Holocaust Research, The New England Journal of Medicine, Partnership, CRC, Cancer, Research, World Cancer Research Fund International, Collection, Risk, Colorectal cancer, Colonoscopy, Accreditation, Mortality, Ageing, Pharmaceutical industry

The partnership marks another significant step forward in providing new and innovative testing options to underserved populations in the battle against colorectal cancer (“CRC”).

Key Points: 
  • The partnership marks another significant step forward in providing new and innovative testing options to underserved populations in the battle against colorectal cancer (“CRC”).
  • As an accredited research laboratory sanctioned by the Polish Center for Accreditation, the laboratory is headquartered in Katowice, Poland, and boasts an expansive network of over 300 collection points throughout the country.
  • With a comprehensive portfolio, testDNA is renowned for delivering state-of-the-art genetic-based testing solutions tailored to individual needs.
  • Together, we are well positioned to help transform and improve the current cancer screening options in Poland and provide timely interventions that have the potential to save lives."

U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age

Retrieved on: 
Monday, August 21, 2023
Infectious Diseases, FDA, Pharmaceutical, Health, Aurora, Inc., Pregnancy, University, Senior, Life, Hospital, Gestational age, Public, Safety, The New England Journal of Medicine, Infection, PFE, Clinical trial, Children's Hospital Colorado, University of Colorado School of Medicine, Development, Protein, RSV, Risk, Respiratory syncytial virus vaccine, Immunization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Vaccine, Pfizer

ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

Key Points: 
  • ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.
  • “We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available.
  • These results were published in The New England Journal of Medicine in April 2023.
  • Simões, M.D., Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora.

Eisai Presents Latest Analysis of Lecanemab's Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer's Association International Conference (AAIC) 2023

Retrieved on: 
Thursday, July 20, 2023
PK, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GFAP, Glial fibrillary acidic protein, Clinical trial, SC, The New England Journal of Medicine, Pathology, PET, Brain, Biomarker, Clarity, Plasma, AAIC, Fluid mechanics, Amyloid, Astrocyte, Neurogranin, Lecanemab, AD, FDA, Conference, Food, Safety, Biogen, Medical imaging, Pharmaceutical industry, Alzheimer's disease, CSF

This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.

Key Points: 
  • This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.
  • The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease (AD) on July 6, 2023.
  • In an exposure/bioavailability and modeling study comparing intravenous (IV) and subcutaneous (SC) dosing of lecanemab, the bioavailability of SC dosing of lecanemab was shown to be approximately 50% of that of IV dosing.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Eisai: FDA Grants Traditional Approval for LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Friday, July 7, 2023
Amyloid-related imaging abnormalities, Insurance, Disease, CMS, Clinical trial, PCNS, The New England Journal of Medicine, Deficit spending, Research, Today, MCI, Neurotoxicity, Committee, Medicare, Clarity, ARIA, HIV disease progression rates, Patient, Immunoglobulin G, Co-promotion, Diagnosis, Lecanemab, AD, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, ADCS, Conditional sentence, Pharmaceutical industry, Alzheimer's disease, Biogen, Eisai

Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.

Key Points: 
  • Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.
  • LEQEMBI treatment reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.
  • Importantly, following FDA's traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available and released more details on the registry, including the easy-to-use data submission process.
  • "Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer's disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease.

89bio Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, August 9, 2023
New England, EASL, Cirrhosis, Histology, Non-cirrhotic portal fibrosis, NASH, F2, Week, Triglyceride, The New England Journal of Medicine, FGF21, Biomarker, ELF, Sale, A1C, Congress, Fibrosis, Vital signs, Patient, Administration, Liver, Fasting, Research and development, DEXA, ALT, R, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Safety, Glycated hemoglobin, Pharmaceutical industry, Medical imaging, Cryptocurrency, Nature Medicine, G&A, NEJM

SAN FRANCISCO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the second quarter ended June 30, 2023.

Key Points: 
  • The data were simultaneously presented in a late-breaking oral session at the EASL Congress 2023 in Vienna, Austria and were also selected for inclusion in the Best of EASL Congress summary.
  • The Company intends to meet with the U.S. Food and Drug Administration in the second half of 2023 and to pursue European Union scientific advice in parallel.
  • As of June 30, 2023, 89bio had cash, cash equivalents and short-term available-for-sale securities totaling $478.0 million.
  • 89bio reported a net loss of $38.4 million for the three months ended June 30, 2023, compared to a net loss of $25.1 million for the three months ended June 30, 2022.

Vertex Announces Publication of VX-548 Positive Phase 2, Proof-of-Concept Results in New England Journal of Medicine

Retrieved on: 
Thursday, August 3, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, The New England Journal of Medicine, Medical Affairs Bureau, Emergency medicine, VRTX, Vertex, Medicine, Associate, NEJM, Harvard Medical School, Pain, Breakthrough therapy, Abdominoplasty, Patient, Manuscript, Hypoventilation, Neuropathic pain, Safety, Vertex Pharmaceuticals, Pharmaceutical industry, Brigham

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced publication in the New England Journal of Medicine (NEJM) of preclinical data and the results from its Phase 2 proof-of-concept trials evaluating treatment with the selective, oral NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty and bunionectomy surgeries.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced publication in the New England Journal of Medicine (NEJM) of preclinical data and the results from its Phase 2 proof-of-concept trials evaluating treatment with the selective, oral NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty and bunionectomy surgeries.
  • The Phase 2 results from VX-548 show the potential this medicine could bring to patients.”
    Vertex expects to complete the pivotal program in late 2023 and share results from these studies in late 2023 or early 2024.
  • VX-548 has been granted Breakthrough Therapy and Fast Track designations in the U.S. for moderate to severe acute pain.
  • In addition, Vertex has initiated a Phase 2 dose-ranging study of VX-548 in neuropathic pain.

Zetron and EaseAlert Partner to Bring 'Heart-Smart' Communications to First Responders

Retrieved on: 
Thursday, August 3, 2023
Heart, Computer-aided dispatch, The New England Journal of Medicine, CT, Firefighter, Engineering, CAD, Vibration, Splenic infarction, Cardiovascular disease, Expo Hall, Research, Association of Public-Safety Communications Officials-International, Emergency, MAX, Death, LED, Risk, National Fire Protection Association, Health, APCO, Medical device, Zetron

REDMOND, Wash., Aug. 3, 2023 /PRNewswire-PRWeb/ -- Zetron, a global leader in integrated mission critical communications technology, today announced it has partnered with EaseAlert, a pioneer in heart-smart Firefighter Alerting Systems (FFAS), to integrate EaseAlert's pre-alerting solutions with Zetron's MAX Fire Station Alerting system. The integration enables either a Computer Aided Dispatch (CAD) system or MAX Fire Station Alerting to trigger vibration and LED notifications directly to wrist-worn devices on firefighters just prior to conventional audible tones being broadcast. The gentle 'pre-alert' is designed to reduce the harmful physical and psychological impacts to firefighters of being routinely and unexpectedly startled by brash piercing audible alarms.

Key Points: 
  • By integrating with EaseAlert we're now also able to support improved heart health by reducing stress, lowering blood pressure and decreasing the risk of heart attacks in firefighters."
  • "Teaming with Zetron to bring heart-smart notification technology to its MAX Fire Station Alerting system helps us accomplish that mission.
  • Together, we'll bring health and productivity benefits to emergency responders across North America, and eventually the world."
  • Zetron and EaseAlert will demonstrate the MAX Fire Station Alerting and EaseAlert FFAS integration live at the upcoming Association of Public Safety Communications Officials (APCO) annual conference in Nashville, TN (USA) on August 7th and 8th.