Lancet

Cerevel Therapeutics Announces Publication in The Lancet of Emraclidine Data from Phase 1b Clinical Trial in People Living with Schizophrenia

Retrieved on: 
Thursday, December 15, 2022
Behavior, Marketing, Yale school, Positive and Negative Syndrome Scale, Delusion, Growth, HIV disease progression rates, Research, COVID-19, Life, Schizophrenia International Research Society, Clinical trial, Cardiovascular disease, American College, FDA, Safety, Congress, Biotechnology, Diabetes, Disability, Child, Psychology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Adolescence, Extrapyramidal symptoms, Hallucination, Epilepsy, Symptoms of COVID-19, Brain, Patient, Degenerative disease, Translational research, PANSS, Pharmacokinetics, Yale School of Medicine, Government budget balance, Obesity, Therapy, Positive, Risk, Weight gain, Pharmaceutical industry, Dietary supplement, Medical imaging, Neuroscience, Schizophrenia, Lancet, Psychiatry

CAMBRIDGE, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced today the publication of data from its Phase 1b clinical trial of emraclidine, a novel muscarinic M4 selective positive allosteric modulator, in adults living with schizophrenia in The Lancet.

Key Points: 
  • Recently, in order to accelerate a potentially registrational package for emraclidine in schizophrenia, the company also initiated EMPOWER-3, a 52-week open-label safety extension trial.
  • This two-part, phase 1b trial was designed to assess the safety and tolerability of emraclidine in people living with schizophrenia.
  • The first part of the trial (part A) was a multiple ascending-dose design to establish safety, tolerability, and appropriate dosing based on pharmacokinetics.
  • Current pharmacologic treatments for schizophrenia primarily target excessive striatal dopaminergic signaling by directly antagonizing postsynaptic dopamine D2 receptor subtypes.

UK marketing authorisations for IOPIDINE® (apraclonidine) fully transferred to Essential Pharma as change in UK NICE guidelines for glaucoma treatment expected to lead to increase in patients’ need for product

Retrieved on: 
Thursday, December 15, 2022
Acquisition, Trabeculoplasty, OHT, Eye, Essential, NICE, Ocular hypertension, MA, NHS, Intraocular pressure, UCL, Moorfields, Pressure, Health, COAG, Ageing, Growth, History, Risk, SLT, Glaucoma, Patient, Light, Fine chemical, Pharmaceutical industry, Lancet, EU, Novartis, Ophthalmology

Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial, Lancet.

Key Points: 
  • Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial, Lancet.
  • Essential Pharma operates globally, supplying a portfolio of over 150 essential medicines across multiple therapeutic areas.
  • Essential Pharma's growth strategy is based around identifying and acquiring mature, at-risk products from larger pharmaceutical groups looking to streamline their product portfolios.
  • Essential Pharma's growth strategy is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long term sustainable growth, including healthcare.

CMS (867.HK) Joins Hand with Incyte on Ruxolitinib Cream, Brings 1st Repigmentation Drug for Vitiligo Patient

Retrieved on: 
Tuesday, December 6, 2022
Cream, Janus, Woman, JAK, Sclerotherapy, Quality of life, AD, Incidence, Partnership, Atopic dermatitis, Heredity, Autoimmune disease, Marketing, FDA, Safety, Vitiligo, CMS, Skin, Tablet, Dermatology, PD-1, Neck, TCS, Face, Plasma protein binding, Territory, Conditional sentence, Patient, Report, Alopecia areata, Prejudice, Varicose veins, Disease, Ruxolitinib, Patent, FGFR1, Janus kinase 1, Week, TCI, Pharmaceutical industry, Fine chemical, Lancet, Incyte, Novartis, Lilly

Ruxolitinib Cream is the only topical JAK inhibitor and the first vitiligo repigmentation drug approved by the U.S. FDA.

Key Points: 
  • Ruxolitinib Cream is the only topical JAK inhibitor and the first vitiligo repigmentation drug approved by the U.S. FDA.
  • Through this transaction, CMS once again brings a novel treatment option for patients with unmet medical needs.
  • The product was approved by the FDA in July 2022 for the topical non-segmental vitiligo patients.
  • In July this year, Ruxolitinib Cream became the first and only drug approved by the U.S. FDA for vitiligo patients repigmentation.

Click Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Episodic Migraine

Retrieved on: 
Friday, December 16, 2022
Health, Technology, Neurology, Health Technology, Software, Pharmaceutical, Highs in the Mid-Sixties, Volume 17, Impact, Major depressive disorder, Neurology, Clinical trial, Employment, The Lancet, Geisel School of Medicine, Atopic dermatitis, CNS, Prevalence, MS, Verily, Food, Chronic pain, FDA, Breakthrough, ACS, Headache, Injury, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Digital, Journal, Doctor of Philosophy, Global Burden of Disease Study, Disease, MDD, Acute coronary syndrome, MD, Disability, Ageing, CNI, Dynamo, Research, GBD, Therapy, Standard of care, FAAN, Patient, Dartmouth, Pharmaceutical industry, Medical device, Medical imaging, Migraine, Lancet, Head, Schizophrenia, Obesity

Click Therapeutics, Inc. (Click), a leader in Digital Therapeutics as prescription medical treatments, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for CT-132.

Key Points: 
  • Click Therapeutics, Inc. (Click), a leader in Digital Therapeutics as prescription medical treatments, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for CT-132.
  • Clicks CT-132 prescription digital therapeutic is under development as an adjunctive preventive treatment for episodic migraine in patients aged 18 years and older.
  • The program is designed to expedite the development and review of medical devices meeting Breakthrough criteria in the United States.
  • We are thrilled to receive this Breakthrough designation as it will facilitate collaborative discussions with the FDA and help expedite the process of bringing a first-in-class migraine digital therapeutic to patients, said Austin Speier, Chief Strategy Officer of Click Therapeutics.

Anumana and Pfizer Partner to Enable Early Detection of Underdiagnosed Cardiovascular Disease

Retrieved on: 
Thursday, December 15, 2022
Software, Research, Data Management, Technology, Medical Devices, Hospitals, Artificial Intelligence, Health Technology, Science, Cardiology, FDA, Health, Other Science, Atrial fibrillation, Kidney disease, Diagnosis, Quality of life, Triage, Pulmonary hypertension, Mayo Clinic, Automated ECG interpretation, Cardiac amyloidosis, FDA, Pfizer, Classification, Degenerative disease, Heart, Algorithm, Human, Hyperkalemia, ECG, Research, De novo, Blood, Patient, Nature Medicine, Literature, Medical device, Lancet, Pramana

Anumana, Inc. , an AI-driven health technology company and portfolio company of nference , has entered into a multi-year agreement with Pfizer, Inc. for Anumana to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early suspicion of cardiac amyloidosis.

Key Points: 
  • Anumana, Inc. , an AI-driven health technology company and portfolio company of nference , has entered into a multi-year agreement with Pfizer, Inc. for Anumana to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early suspicion of cardiac amyloidosis.
  • The research agreement with Pfizer will help deepen Anumanas efforts to implement AI-enabled early detection software that can reveal signals from ECGs that humans cannot interpret.
  • Multiple Anumana algorithms have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical trial validation.
  • Anumana algorithms are investigational medical devices and have not yet received regulatory approval or clearance.

Artilysin®: Fearless Into the Post-antibiotic Era

Retrieved on: 
Thursday, December 15, 2022
Veterinary, Research, Medical Devices, Hospitals, Biotechnology, Pharmaceutical, Health, Cosmetics, Retail, Science, Biotechnology, Research and development, Infection, Death, Cosmetics, ABQ BioPark Botanic Garden, Multimedia, WHO, Veterinary medicine, Antibiotics, Vaccine, Research, Lancet

To counter this threat, Lysando AG has developed the so-called Artilysin technology: Novel antimicrobial proteins with a unique mode of action.

Key Points: 
  • To counter this threat, Lysando AG has developed the so-called Artilysin technology: Novel antimicrobial proteins with a unique mode of action.
  • View the full release here: https://www.businesswire.com/news/home/20221215005034/en/
    Lysando AG has developed the so-called Artilysin technology: Novel antimicrobial proteins with a unique mode of action.
  • The Artilysin technology allows the Lysando team to design fit-for-purpose molecules by flexibly combining modules with antibacterial activity.
  • Moreover, the technology for example in topical applications acts locally, does not breach the body's natural barriers or disrupt our skin's natural defense system.

Hygieia adds to team, continues rapid, national expansion of its d-Nav® Insulin Management Program

Retrieved on: 
Tuesday, December 13, 2022
Technology, Research, Diabetes, Other Technology, Biotechnology, Health, General Health, Other Science, Science, Therapy, Physician, Insulin, Patient, Research, FDA, RNS, Growth, Lancet, Marketing, American Medical Group Association, National Association Medical Staff Services, Risk, Pharmaceutical industry, Medicine, Medical device, Hygieia

For more information on Hygieia and the d-Nav insulin management technology, visit d-Nav.com or call 734-369-9980.

Key Points: 
  • For more information on Hygieia and the d-Nav insulin management technology, visit d-Nav.com or call 734-369-9980.
  • The d-Nav Insulin Management Program adds clinical support that helps people with type 2 diabetes adjust their insulin doses according to their bodys changing insulin needs.
  • The d-Nav Insulin Management Program has been peer-reviewed with studies published in leading medical journals.
  • Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial.

A New Study From Hello Heart Shows Surprising Findings on Walking Patterns and Heart Health

Retrieved on: 
Tuesday, December 13, 2022
Apps, Applications, Technology, Mobile, Wireless, Fitness & Nutrition, Other Technology, Health Technology, Cardiology, Health, Artificial Intelligence, Therapy, Heart, Ecosystem, SBP, Chief Medical Advisor to the President, Weapon, Meta-analysis, Death, Cardiovascular disease, AI, Weight loss, Behavior, News, Risk, Fortune 500, Multimedia, Degenerative disease, Lancet, Hypertension, American Heart, Health, Stroke, Blood pressure, Walking, Pharmaceutical industry, Salt, Dietary supplement, Medical device, Medical imaging, Dot

(Graphic: Business Wire)

Key Points: 
  • (Graphic: Business Wire)
    The findings were collected from 6,000 Hello Heart users nationwide over six months.
  • Hello Heart is helping people to understand how their individual behavior correlates to the impact on their heart health.
  • Using Hello Heart to track my blood pressure readings regularly has really allowed me to take much more control over my heart health.
  • Founded in 2013, Hello Heart is a member of the American Heart Associations Innovators Network and is part of the CVS Health Point Solutions Management program.

Cenobamate (ONTOZRY®), for the Treatment of Uncontrolled Focal-onset Seizures in Adults, Is Now Available in France and Belgium

Retrieved on: 
Wednesday, December 7, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Other Health, Pharma, Lancet, Safety, Patient, ASMS, European Medicines Agency, History, Seizure, Pharmaceutical industry

Angelini Pharma is committed to helping patients in the therapeutic areas of Brain Health and Consumer Healthcare.

Key Points: 
  • Angelini Pharma is committed to helping patients in the therapeutic areas of Brain Health and Consumer Healthcare.
  • In January 2021, Angelini Pharma announced that they concluded a definitive merger agreement under which Angelini Pharma acquired Arvelle Therapeutics.
  • Cenobamate is a novel small molecule that provides a dual, complementary mechanism of action aimed at treatment of seizures.
  • Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicenter, double-blind, randomized, placebo-controlled, dose-response trial.

Lunit AI Can Help Tuberculosis Screening in Prisons, as Published in The Lancet Regional Health - Americas

Retrieved on: 
Thursday, December 15, 2022
INSIGHT, TPP, Mato, Algorithm, General medical journal, Prison, Tuberculosis, AI, Federal University of Mato Grosso do Sul, World Health Organization, Sputum, Multimedia, WHO, TB, Lancet, National university, AUROC, Radiology, CAD, Male, Pharmaceutical industry, Medical device, Medical imaging

The AI solution can detect 10 of the most common chest abnormalities, including tuberculosis, with 97-99% accuracy.

Key Points: 
  • The AI solution can detect 10 of the most common chest abnormalities, including tuberculosis, with 97-99% accuracy.
  • Researchers performed prospective TB screening in three male prisons in Brazil from October 2017 to December 2019.
  • The Lancet is an international peer-reviewed general medical journal and the world's highest-impact academic journal (impact factor: 202.7).
  • [2]WHO consolidated guidelines on tuberculosis: module 2: screening: systematic screening for tuberculosis disease, 2021
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