Incidence

Newron Announces Positive Top-line Results From Potentially Pivotal Phase II/III Study 008A With Evenamide in Schizophrenia Patients

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星期二, 四月 30, 2024
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Clinical Global Impression, Clozapine, NCE, XETRA, Safety, Psychiatry, MD, PANSS, Common, Extrapyramidal system, CNS, Schizophrenia, Vomiting, Incidence, Patient, Peripheral nervous system, Evenamide, Headache, Positive, Medication, Pharmaceutical industry

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.

Key Points: 
  • Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.
  • 291 patients were randomized to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy.
  • Two hundred and eighty of the 291 patients completed the study with only three patients discontinuing the study due to adverse events, two of them on evenamide and one patient on placebo who died during the study.
  • Ravi Anand, MD, Chief Medical Officer of Newron, stated: “The results seen in study 008A with evenamide are ground-breaking and unique from many perspectives.

Virtual Incision Announces Publication of Data from its U.S. Investigational Device Exemption Study in the Clinical Journal, Diseases of Colon and Rectum

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星期二, 四月 30, 2024
Medical Devices, Health, Surgery, Health Technology, Clinical Trials, General Health, Colorectal surgery, FDA, Lankenau Medical Center, Learning, Safety, Food, IDE, Surgeon, MD, Trial of the century, Doctor of Philosophy, FACS, MIRA, Incidence, Patient, De novo, Aes, Investigational device exemption, Quality of life

Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .

Key Points: 
  • Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .
  • The study was designed to assess the safety and efficacy of MIRA, the world’s first miniaturized robotic-assisted surgery device, in adults undergoing colectomy procedures.
  • Results were provided to the Food and Drug Administration (FDA) as part of the submission to support the de novo marketing authorization of the device.
  • The data demonstrated the following results:
    The primary efficacy endpoint, the successful completion of pre-defined procedural steps without conversion to open surgery, was met.

Dermavant Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

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星期一, 四月 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Other Health, Dermatitis, Itch, Pain, Shanda, Skin, Inflammation, Food, Swelling, Stinger, Rash, Body surface area, Nose, Agency, Atopic dermatitis, Folliculitis, Common, Therapy, PDUFA, Incidence, Patient, Psoriasis, Red, Headache, Irritation, Ageing, Pharmaceutical industry

The Prescription Drug User Fee Act ("PDUFA") action date assigned by the Agency is in Q4 2024.

Key Points: 
  • The Prescription Drug User Fee Act ("PDUFA") action date assigned by the Agency is in Q4 2024.
  • VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD.
  • On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Global Bionic Devices Research Report 2024: Market to Surpass $10.25+ Billion by 2030, Driven by Transformative Impact on Quality of Life in Retaining Mobility and Independence - ResearchAndMarkets.com

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星期一, 四月 29, 2024
General Health, Health, Medical Devices, Conditional sentence, Amputation, WHO, Person, Huber loss, Hearing loss, Disability, Hospital, Bionics, Cardiology, Elective surgery, Growth, Environment, Incidence, Neurology, Disability studies, Consciousness, Dental implant, Crash, Rehabilitation, Ageing, Fixation, Quality of life, Accident, Prevalence, Medical device

The demand for bionic devices has surged in recent times because of their transformative effect on the quality of existence.

Key Points: 
  • The demand for bionic devices has surged in recent times because of their transformative effect on the quality of existence.
  • North America dominated the global bionic devices market in 2023 and is anticipated to lead the market throughout the forecast period.
  • The electronic bionic devices captured a significant share of the global bionic devices market in 2023.
  • It is predicted that the ambulatory surgical centers will capture nearly a quarter share of the total bionic devices market.

Global $4.93 Bn Neonatal Intensive Care Market Trends, Competitive Analysis and Forecasts, 2018-2023 & 2024-2030 - ResearchAndMarkets.com

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星期一, 四月 29, 2024
Medical Devices, Health, Consumer, Hospitals, Baby, Maternity, General Health, Conditional sentence, Hypothermia, Mortality, NICU, Humidity, Infant, Risk, Hospital, Page, Death, Jaundice, SWOT analysis, Medicine, Research, Light, Growth, Heart rate, Observation, Application, Incidence, Patient, Developed country, European Journal, White lung, Pediatrics, Temperature, Government, RDS, Prevalence, Disease, Dietary supplement

North America dominated the global neonatal intensive care market in 2023, followed by Europe.

Key Points: 
  • North America dominated the global neonatal intensive care market in 2023, followed by Europe.
  • Neonatal monitoring devices such as cardiac monitors are used in neonatal intensive care units for continuous monitoring of neonates.
  • The neonatal & pediatric hospital facilities dominate the global neonatal intensive care market because of their specialized information, dedicated infrastructure, and comprehensive services.
  • The increasing number of maternity hospitals offering neonatal intensive care services worldwide increases the popularity of this segment.

Processa Pharmaceuticals Presents Two Abstracts at the AACR Annual Meeting 2024 Including New Data on the NGC-Cap Phase 1b Trial

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星期四, 四月 11, 2024
FDA, Project, NGC, Safety, Food, Abstract, PCSA, Plasma, Publication, Incidence, Patient, Doctor of Pharmacy, Database, Capecitabine, AACR, AUC, ODR, Breast cancer, Pharmaceutical industry

HANOVER, Md., April 11, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, presented two abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2024, including new Phase 1b data on its Next Generation Capecitabine (NGC-Cap) product. These abstracts are available in the Publications section of Processa’s website.

Key Points: 
  • The NGC-Cap Phase 1b trial evaluated ascending doses of capecitabine when combined with a fixed dose of PCS6422 in patients with advanced, relapsed, or refractory progressive gastrointestinal cancer.
  • NGC-Cap demonstrated greater 5-FU (5-fluorouracil) exposure and lower fluoro-beta-alanine (FBAL) exposure with a better or similar side effect profile compared with monotherapy capecitabine.
  • “The most recent data for the Phase 1b NGC-Cap study presented at AACR highlight NGC-Cap’s ability to distribute more 5-FU to cancer cells with 5-10 times greater systemic exposure than when capecitabine is administered alone.
  • “This Phase 1b study is ongoing due to continued patient response and we plan to release final trial data once the database is locked.

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

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星期四, 四月 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.

Penn Highlands Healthcare Advises How to Recognize Autism Spectrum Disorder

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星期三, 四月 10, 2024
Epilepsy, Disorder, Common, ASD, Spectrum, Social skills, Autism spectrum, Communication, Incidence, Eye, Medicine, Child, Diagnosis, Applied behavior analysis, Anatomical pathology, Quality of life, Prevalence

These could be signs that the child has autism spectrum disorder (ASD) – a neurodevelopmental condition that affects how people communicate, behave, learn and interact with others.

Key Points: 
  • These could be signs that the child has autism spectrum disorder (ASD) – a neurodevelopmental condition that affects how people communicate, behave, learn and interact with others.
  • April is National Autism Acceptance Month, a great time to learn more about ASD.
  • Autism is referred to as a “spectrum” disorder due to the extensive range of symptom types and severities that individuals may experience.
  • Since autism was first diagnosed in the U.S. the incidence has climbed to an alarming one in 36 children in the U.S.

FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV

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星期五, 四月 26, 2024
Research, Pharmaceutical, Consumer, Infectious Diseases, Hospitals, Clinical Trials, Science, Baby, Maternity, Biotechnology, Women, AIDS, FDA, Health, University, Boxed warning, Gilead Sciences, Safety, PWH, Pregnancy, Pharmacokinetics, Woman, Food, CDC, Doctor of Philosophy, PCR, Tablet, Incidence, HIV-1, STR, HIV, DHHS, Associate, Plasma, National Medical Association

This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.

Key Points: 
  • This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.
  • Additionally, guidelines recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.
  • “This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant PWH, an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
  • “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant.

United States Gluten-Free Food Products Market Insights 2024: A $4.25 Billion Industry by 2029, Driven by Rising Incidence of Intolerance & Increasing Availability of Diversified Options - ResearchAndMarkets.com

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星期五, 四月 26, 2024
Food, Beverage, Retail, Online, Snack, Irritable bowel syndrome, Flour, Hain Celestial Group, Flowers Foods, Prevalence, Health, Kraft Heinz, Male, Coeliac disease, Life, Mondelez International, Arthritis, Incidence, Supermarket, Perception, Tic disorder, Bread, General Mills, Growth

The U.S. gluten-free food products market is expected to reach a value of 4.25 billion by 2029 from $2.62 billion in 2023, growing at a CAGR of 8.36%

Key Points: 
  • The U.S. gluten-free food products market is expected to reach a value of 4.25 billion by 2029 from $2.62 billion in 2023, growing at a CAGR of 8.36%
    The U.S. gluten-free food products market report contains exclusive data on 28 vendors.
  • The US gluten-free food products market is highly competitive, with established players and emerging brands competing for market share.
  • The rising incidence of celiac disease and gluten intolerance is a major driver in the U.S. gluten-free food products market.
  • The increasing availability of diversified gluten-free food options is a key driver in the U.S. market, contributing to its ongoing growth.