Pharmacotherapy

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: 
Monday, 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: 
Tuesday, 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: 
Thursday, March 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: 
Tuesday, March 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: 
Wednesday, March 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.

American Liver Foundation Statement on FDA Approval of Resmetirom

Retrieved on: 
Thursday, March 14, 2024
HCC, Liver failure, American Liver Foundation, Fatty liver disease, Liver disease, Disease, Caregiver, Risk, Cirrhosis, Inflammation, Chairperson, Patient, Life, Liver transplantation, Hope, Doctor of Philosophy, MASH, MD, ALF, Pharmacotherapy, Fibrosis, NASH, Hepatology, Hepatocellular carcinoma, NAFLD, FDA, Liver, Food, Pharmaceutical industry

FAIRFIELD, N.J., March 14, 2024 /PRNewswire/ -- Today, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis. NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease* (NAFLD) and causes inflammation in the liver and liver damage.

Key Points: 
  • NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease * (NAFLD) and causes inflammation in the liver and liver damage.
  • "American Liver Foundation applauds the FDA approval of the groundbreaking new drug therapy treatment, resmetirom, for patients with NASH who have progressed to fibrosis," said Lorraine Stiehl , Chief Executive Officer, American Liver Foundation.
  • American Liver Foundation offers many free resources to patients and families affected by liver disease.
  • *Note: The nomenclature for NAFLD and NASH recently changed to metabolic dysfunction-associated liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) respectively.

StrainsForPains, Inc. Discusses Inspiration, App Technology and CBD Market Entrance with The Stock Day Podcast

Retrieved on: 
Thursday, February 29, 2024
Pet, Anxiety, Parkinson's disease, Intelligence, Traction, Chemical oxygen demand, DSM-IV codes, Quality of life, Cancer, MIT, Pain, OTC Markets Group, State, Database, Cannabinoid, State university system, International Cannabinoid Research Society, Chronic pain, Business, SUNY, Depression, CBD, Patient, Medicine, Osteoarthritis, Pharmacotherapy, Movement, Interview, Insomnia, Cannabis, Research, Alzheimer's disease

I financed and worked with Olivia Newton-John's Koala Blue in the 1980's and Richard Diehl's Graphsoft (now Vectorworks) in the 1990's.

Key Points: 
  • I financed and worked with Olivia Newton-John's Koala Blue in the 1980's and Richard Diehl's Graphsoft (now Vectorworks) in the 1990's.
  • I developed regenerative medicine systems with stem cell technology in the 1980's working on umbilical cord therapy to treat genetic diseases, cancers, and inherited disorders.
  • In 2024 we will focus our efforts on the development of our upcoming advanced AI app and our CBD brand that will expand into many products.
  • We will seek to forge a new path in our approach to healthcare, that will expand to CBD products for pets as well as a nutritional app.

Sharps Technology and Roncadelle Operations Sign Worldwide Sales and Distribution Agreement for their Innovative Portfolio of Safe Technology Drug Delivery Systems

Retrieved on: 
Thursday, March 7, 2024
Needle, FDA, Weight loss, Syringe, Vaccine, Communication, CDMO, Safety, Administration, World Health Organization, Pharmacotherapy, Partnership, Pharmaceutical industry

The agreement, signed on March 4, 2024, lays the groundwork for further collaboration between Sharps and Roncadelle to develop and manufacture next-generation drug delivery products.

Key Points: 
  • The agreement, signed on March 4, 2024, lays the groundwork for further collaboration between Sharps and Roncadelle to develop and manufacture next-generation drug delivery products.
  • “We believe that this is just the beginning of Sharps’ collaboration with Roncadelle.
  • “This alliance underscores our unwavering commitment to innovation and excellence, reshaping standards within the global healthcare landscape.”
    Sharps Technology specializes in the development and manufacturing of innovative drug delivery systems.
  • As part of the cooperative agreement, Sharps and Roncadelle intend to collaborate on the development of new drug delivery products.

Osmol Therapeutics Appoints Ron Weitzman, M.D., as Interim Chief Medical Officer

Retrieved on: 
Monday, March 4, 2024
Montreal Cognitive Assessment, CIPN, Prostate cancer, Chemotherapy-induced peripheral neuropathy, MBA, Therapy, Internal medicine, Drug, Novartis, Pharmacotherapy, Oncology, IND, CICI, Pharmaceutical industry

NEW HAVEN, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Osmol Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing preventative treatments for chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced cognitive impairment (CICI), today announced that it has appointed Ron Weitzman, M.D., as interim Chief Medical Officer, replacing Arthur DeCillis, M.D., who is joining Osmol’s Scientific Advisory Board.

Key Points: 
  • NEW HAVEN, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Osmol Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing preventative treatments for chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced cognitive impairment (CICI), today announced that it has appointed Ron Weitzman, M.D., as interim Chief Medical Officer, replacing Arthur DeCillis, M.D., who is joining Osmol’s Scientific Advisory Board.
  • “We are pleased to welcome Ron, with his significant oncology drug development expertise, to the Osmol team,” said Bob Linke, MBA, President and CEO of Osmol Therapeutics.
  • Ron Weitzman, M.D., has held leadership roles at various global biopharmaceutical companies, including Tango Therapeutics, Exelixis, Genentech and Novartis.
  • Most recently he served as Chief Medical Officer at Tango Therapeutics, where he oversaw development of multiple oncology drugs, including three Investigational New Drug (IND) applications, while leading the clinical and clinical operations teams.

Sharps Technology Enters Latin American Market and Receives First Orders for Securegard Disposable Smart Safety Syringes from Strategic Distribution Partner in Colombia

Retrieved on: 
Wednesday, February 21, 2024
Safety, Hospital, Pharmacotherapy, World Health Organization, Sale, Pharmacy, Patient, Pharmaceutical industry

The initial product orders have been placed through a collaborative effort between Sharps and a Latin American distribution partner based in Colombia and represent a significant step towards promoting safer healthcare practices in the region.

Key Points: 
  • The initial product orders have been placed through a collaborative effort between Sharps and a Latin American distribution partner based in Colombia and represent a significant step towards promoting safer healthcare practices in the region.
  • “We are building strategic partnerships within the entire Latin American distribution network to support region-wide efforts to improve medical safety and healthcare outcomes.
  • The introduction of Securegard technology into Latin America can greatly enhance the overall quality level of healthcare available in that market.
  • For additional information on Sharps Technology and its Securegard smart safety syringes, please visit www.sharpstechnology.com .