Pharmacotherapy

AUA/SUFU Guideline on the Treatment of Overactive Bladder Allows Access to ReviTM System Earlier in Treatment Journey

Retrieved on: 
Montag, April 29, 2024
FDA, Commercial software, Society, Risk, Urinary incontinence, Food, De novo, American Urological Association, Paruresis, Pharmacotherapy, MMHC, Guideline, OAB, Deficit spending, Prescription, Patient, Neuromodulation, Physician, AUA, Ankle, Diagnosis, SUFU, Anticholinergic, Female

The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.

Key Points: 
  • The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.
  • First, the guidelines were updated to include iTNM as an acceptable minimally invasive therapy.
  • "We are delighted to witness the transformation of the new OAB treatment guideline by the AUA/SUFU.
  • This guideline represents a significant turning point in physicians' approach to OAB management," commented Dan Lemaitre, Chief Executive Officer of BlueWind Medical.

Benitec Biopharma Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study

Retrieved on: 
Donnerstag, April 18, 2024
FDA, Dysphagia, Mutation, EDT, Nature, COMP, Oculopharyngeal muscular dystrophy, Hope, Food, News, Death, Yogurt, Pharmacotherapy, Observation, PABPN1, Disease, OPMD, Subject, Ptosis, Patient, EMA, Caregiver, Committee, Clinical trial, Trial of the century, Orphan drug, European Medicines Agency, Pharmaceutical industry

HAYWARD, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announces positive interim clinical data from the 90-day timepoint following the administration of BB-301 to the study’s first subject (Subject 1) treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD). BB-301 has been granted Orphan Drug designation by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

Key Points: 
  • “To date, no clinical studies have systematically demonstrated a clinical improvement in OPMD patients across both objective and subjective measures of swallowing.
  • We are, therefore, pleased to report positive interim clinical data from multiple radiographic measures as well as subject-reported outcome measures from the first subject treated with BB-301,” said Jerel A.
  • Videofluoroscopic swallowing studies represent the gold standard analytical method for the quantitative assessment of dysphagia (swallowing difficulty) in the clinical setting.
  • The event replay will be placed on the News & Events tab on the Investor page of the Benitec website.

Remepy Launches with $15 Million in Funding To Bring First Hybrid Drug To Market

Retrieved on: 
Mittwoch, Mai 1, 2024
Research, Infectious Diseases, Clinical Trials, Health Technology, Philanthropy, General Health, Pharmaceutical, Health, Science, Oncology, Brain, MCI, Cancer, IP, Blood, Magnetic resonance, Immunotherapy, Pharmacotherapy, Speech, Digital, Therapy, Moa, Patient, Physician, Movement, Biomarker, Immune system, Mechanism, Sensory deprivation, Medical imaging

Remepy, a pioneer in “hybrid drugs,” today announced that it has successfully closed a $10M seed investment round, which together with earlier funding totals $15M.

Key Points: 
  • Remepy, a pioneer in “hybrid drugs,” today announced that it has successfully closed a $10M seed investment round, which together with earlier funding totals $15M.
  • The digital molecules are designed for hybrid drug experiences.
  • Remepy’s innovative approach creates a new market for hybrid medications, and a whole new world of data and IP assets for pharmaceutical companies.
  • Remepy is pioneering Hybrid Drugs: traditional drugs combined with digital therapeutics that are personalized and enhance the effect of pharmaceutical treatments.

Novotech Publishes Research Report on Acute Myeloid Leukaemia Clinical Trial Landscape for Clinical Stage Biotechs

Retrieved on: 
Donnerstag, April 11, 2024
Contract research organization, IDH2, FDA, Mutation, Acute myeloid leukemia, SWOT, Risk, Research, Prognosis, AML, USFDA, Leukemia, Pharmacotherapy, Therapy, Smoking, Incidence, Azacitidine, Protein, ROW, FLT3, Standard of care, Acute promyelocytic leukemia, Drug development, Biomarker, Clinical trial, IDH1, Growth, Pharmaceutical industry

BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.

Key Points: 
  • BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.
  • Importantly it also includes an in-depth SWOT analysis to guide strategic decision-making, prioritize research areas, and identify challenges for clinical stage biotechs.
  • The Acute Myeloid Leukaemia (AML) - Global Clinical Trial Landscape report notes that since 2019, the global biotech and biopharmaceutical industry initiated over 1,000 clinical trials for AML.
  • These reports offer current insights into global clinical trial activity, revealing which regions experience the highest trial volumes and the unique factors behind these trends.

Green Circle Life Expands Availability of Healthy Weight for Life Program for the SmartFHR™ Platform

Retrieved on: 
Dienstag, April 16, 2024
Technology, Professional Services, Health, Pharmaceutical, Health Technology, Health Insurance, Data Analytics, Software, Fitness & Nutrition, Human Resources, Telemedicine, Virtual Medicine, Snack, ROI, Pharmacy, NCQA, AutoZone, HR, Eli Lilly, Insurance, Compensation, Partnership, Weight loss, Doctor of Philosophy, Quality assurance, Pharmacotherapy, Prescription, Obesity, Exercise, Life, Novo Nordisk, Diet, GCL, Workforce, National Committee, Quality of life

HWFL is an employer-offered weight management program designed to work with individuals to set realistic goals, attain and maintain their desired weight through lifestyle changes.

Key Points: 
  • HWFL is an employer-offered weight management program designed to work with individuals to set realistic goals, attain and maintain their desired weight through lifestyle changes.
  • The program, which provides private, personalized coaching, encourages users to engage in physical activities, nutritional adjustments and monitor weight outcomes.
  • Dinesh Sheth, founder and CEO of Green Circle Life, emphasized, “Health and wellness are at the forefront of HR challenges, and obesity is a national epidemic.
  • Healthy weight is not a 'one and done' 'one size fits all' proposition but rather a constantly evolving journey.

Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs

Retrieved on: 
Montag, April 1, 2024
Harvard Medical School, Investigational device exemption, Human, Obesity, Cardiovascular disease, Exercise, Risk, Patient, Food and Drug Administration, Weight loss, IDE, MD, Diet, Pharmacotherapy, Duodenum, Hospital, T2D, Wellness, Pathology, Therapy, BMI, FDA, Endoscopy, Food, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced U.S. Food and Drug Administration (FDA) approval of a pivotal Investigational Device Exemption (IDE) to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist (GLP-1RA) drug therapy, addressing a key unmet need in the treatment of obesity. Obesity affects over 40% of the US population and is a critical precursor to various highly morbid and expensive chronic conditions such as type 2 diabetes, metabolic dysfunction-associated fatty liver disease, and cardiovascular disease.

Key Points: 
  • The IDE approval launches the groundbreaking Remain-1 study, set to begin in the second half of 2024.
  • Remain-1 is a randomized, double-blind trial of Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy.
  • It is designed to be a pivotal study to potentially enable registrational filing for Revita for weight maintenance after GLP-1RA discontinuation.
  • The rationale for the Remain-1 pivotal study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy.

BlueWind Medical Revi™ Patient-Centric Solution for Urge Urinary Incontinence Now Available at Mount Carmel Health in Ohio

Retrieved on: 
Dienstag, April 9, 2024
Physician, Patient, Tibial, OASIS, Ankle, Quality of life, Pharmacotherapy, Urinary incontinence, Safety, Commercial software, Neuromodulation, FDA, Medical device

PARK CITY, Utah, April 9, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a trailblazer in patient-centric healthcare innovations, announced that distinguished urologist Dr. Jeffrey Carey of the Central Ohio Urology Group is now offering Revi implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI).

Key Points: 
  • PARK CITY, Utah, April 9, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a trailblazer in patient-centric healthcare innovations, announced that distinguished urologist Dr. Jeffrey Carey of the Central Ohio Urology Group is now offering Revi implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI).
  • "Many of my patients are looking for an alternative to ongoing drug therapy" shared Dr. Jeffrey Carey.
  • "Revi provides individually tailored therapy that patients deliver themselves, on their schedule, and at their convenience.
  • Coupled with the excellent safety and efficacy of Revi, it's a welcome choice for urge incontinence patients."

Lyra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Donnerstag, März 21, 2024
Research, LYRA, Common, Bronchitis, Disease, MF, New Drug Application, COVID-19, Patient, Smell, Network congestion, CRS, United, Nasal cavity, Pharmacotherapy, Investment, Clinical trial, Therapy, Safety, Sinusitis, ESS, FDA, Food, Pharmaceutical industry

WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.  

Key Points: 
  • WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.
  • LYR-220, a larger insert, is designed for CRS patients whose nasal cavity is enlarged due to previous ESS.
  • Cash, cash equivalents and short-term investments were $102.8 million as of December 31, 2023, compared to $102.6 million as of September 30, 2023.
  • The Company recorded an impairment charge of $1.6 million related to long-lived assets for the year ended December 31, 2023.

Teva UK and Closed Loop Medicine Announce Strategic Partnership to Advance Development of Personalised Medicines

Retrieved on: 
Dienstag, März 26, 2024
Software, Biotechnology, Pharmaceutical, Health, Medical Devices, Health Technology, Technology, Clinical Trials, Disease, Ulcerative colitis, Risk, Partnership, Patient, NHS, Mortality, Pivot, Pharmacotherapy, Investment, Clinical trial, Annual report, Inflammatory bowel disease, Teva, Therapy, Hypertension, Medicine, Pharmaceutical industry

Teva UK Limited and Closed Loop Medicine Ltd have announced a strategic partnership to advance the development of personalised medicines.

Key Points: 
  • Teva UK Limited and Closed Loop Medicine Ltd have announced a strategic partnership to advance the development of personalised medicines.
  • Under the agreement, Closed Loop Medicine – a leading TechBio company – and pharmaceutical company, Teva UK, will investigate opportunities to use Closed Loop Medicine’s proprietary software as a medical device (SaMD) technology platform which aims to advance the development of personalised medicines, improve drug efficacy and outcomes in patients with specific chronic disorders by combining dose-optimised drug therapy with digital care.
  • Dr Paul Goldsmith, Chief Medical Officer and Innovation Officer, Co-Founder and President of Closed Loop Medicine, said: “As clinicians, we know that dosing of drugs is a huge problem.
  • Being able to predict personalised dose levels could be transformational.”
    This strategic partnership harnesses Closed Loop Medicine’s proprietary SaMD and combines it with Teva’s pharmaceutical products creating the opportunity for digital companions to be prescribed alongside traditional therapeutics, enabling real-world data integration and improved effectiveness of innovative and known medicines.

Patients in Utah Now Have Access to the Novel Revi™ Implantable Tibial Neuromodulation Device for the Treatment of Urge Urinary Incontinence

Retrieved on: 
Mittwoch, März 27, 2024
Physician, Patient, OASIS, University, Ankle, Quality of life, Pharmacotherapy, Urinary incontinence, Commercial software, Neuromodulation, FDA

PARK CITY, Utah, March 27, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient-centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Revi is now available in Utah with urologist Dr. Sara Lenherr at the University of Utah.

Key Points: 
  • "Revi is a solution for the millions of people dealing with Urge Urinary Incontinence (UUI).
  • I look forward to offering Revi to my patients, especially those who are unable to tolerate, afford, or are not good candidates for drug therapy," shared Dr. Sara Lenherr.
  • "Revi offers a patient-centered design, which allows for individually tailored therapy that patients can deliver themselves, on their schedule and at their convenience."
  • UUI is a common and debilitating condition, affecting approximately 16 million people in the U.S., most of whom never receive effective treatment.