Placebo

GENFIT Reports Full-Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, April 4, 2024
MAA, ACLF, Primary biliary cholangitis, Patient, Research, Ipsen, Placebo, EMA, Bank statement, Marketing, PBC, FDA, EF, Pharmaceutical industry

“A remarkable milestone was reached by GENFIT in 2023 with the announcement of positive topline data for our Phase 3 ELATIVE® trial evaluating elafibranor in Primary Biliary Cholangitis.

Key Points: 
  • “A remarkable milestone was reached by GENFIT in 2023 with the announcement of positive topline data for our Phase 3 ELATIVE® trial evaluating elafibranor in Primary Biliary Cholangitis.
  • This was followed by another asset acquisition in July 2023, where GENFIT licensed the exclusive worldwide rights of CLM-022, a potential first-in-class inflammasome inhibitor, from Celloram.
  • IND was in effect as of April 17, 2023 and the first patient was randomized in the UNVEIL-IT® Phase 2 trial in July 2023.
  • GENFIT equally obtained a “Prime status” label by ISS ESG, upgrading its corporate rating from C to C+.

Attention Disc Medicine, Inc. Investors: Company Investigated by the Portnoy Law Firm

Retrieved on: 
Monday, April 1, 2024
Patient, Placebo, Disc, IRON, Erythropoietic protoporphyria, EPP

LOS ANGELES, April 01, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Disc Medicine, Inc. (“Disc” or the “Company”) (NASDAQ: IRON) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Disc stock. Disc investors are encouraged to contact the firm to discuss their legal rights.

Key Points: 
  • LOS ANGELES, April 01, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Disc Medicine, Inc. (“Disc” or the “Company”) (NASDAQ: IRON) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Disc stock.
  • Disc investors are encouraged to contact the firm to discuss their legal rights.
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
  • The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing.

Acadia Pharmaceuticals Announces Top-Line Results from Phase 3 ADVANCE-2 Trial of Pimavanserin in Negative Symptoms of Schizophrenia

Retrieved on: 
Monday, March 11, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Somatic symptom disorder, Patient, Placebo, ACAD, Schizophrenia, Safety, Pharmaceutical industry

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the Phase 3 ADVANCE-2 trial evaluating pimavanserin for the treatment of negative symptoms of schizophrenia.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the Phase 3 ADVANCE-2 trial evaluating pimavanserin for the treatment of negative symptoms of schizophrenia.
  • The safety and tolerability profile of pimavanserin was consistent with previous clinical trials, showing a low rate of adverse events.
  • “We are disappointed the trial did not meet its primary endpoint given the significant unmet need in patients with negative symptoms of schizophrenia,” said Steve Davis, Acadia’s Chief Executive Officer.
  • In ADVANCE-2, pimavanserin was well-tolerated with an adverse event rate of 30.4% compared with 40.3% for the placebo arm.

Clinical Trial Supply & Logistics Market Projected to Reach $41.04 billion by 2030 - Exclusive Report by 360iResearch

Retrieved on: 
Monday, March 25, 2024
Catalent, Medical device, Temperature, Growth, Prevalence, Face, Molecule, Thermo Fisher Scientific, Medication, CTSL, Pharmacy, Partnership, Intelligence, Imp, Conditional sentence, ICON, Global health, Research, Good manufacturing practice, IMP, Transport, ICON PLC, Placebo, Infosys, GMP, Excipient, Investment, Clinical trial, GDP, Drug development, API, Clinical data management, Table, Ageing, Parexel

"Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"

Key Points: 
  • "Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"
    Clinical trial supply and logistics (CTSL) is a critical backbone for conducting clinical studies worldwide, providing essential services, including planning, storing, managing, and distributing clinical trial materials (CTMs).
  • South America also sees increased adoption of clinical trial supply and logistics, fueled by its developing healthcare infrastructure.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Clinical Trial Supply & Logistics Market.
  • "Dive into the Clinical Trial Supply & Logistics Market Landscape: Explore 187 Pages of Insights, 582 Tables, and 26 Figures"

Clinical Trial Supply & Logistics Market Projected to Reach $41.04 billion by 2030 - Exclusive Report by 360iResearch

Retrieved on: 
Monday, March 25, 2024
Catalent, Medical device, Temperature, Growth, Prevalence, Face, Molecule, Thermo Fisher Scientific, Medication, CTSL, Pharmacy, Partnership, Intelligence, Imp, Conditional sentence, ICON, Global health, Research, Good manufacturing practice, IMP, Transport, ICON PLC, Placebo, Infosys, GMP, Excipient, Investment, Clinical trial, GDP, Drug development, API, Clinical data management, Table, Ageing, Parexel

"Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"

Key Points: 
  • "Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"
    Clinical trial supply and logistics (CTSL) is a critical backbone for conducting clinical studies worldwide, providing essential services, including planning, storing, managing, and distributing clinical trial materials (CTMs).
  • South America also sees increased adoption of clinical trial supply and logistics, fueled by its developing healthcare infrastructure.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Clinical Trial Supply & Logistics Market.
  • "Dive into the Clinical Trial Supply & Logistics Market Landscape: Explore 187 Pages of Insights, 582 Tables, and 26 Figures"

Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US

Retrieved on: 
Thursday, March 7, 2024
CHIM, Placebo, USD, Otto, ETEC, Diarrhea, Gastrointestinal tract, Food, Treatment, BLA, Enterotoxigenic Escherichia coli, Bacteria, ASX, Food and Drug Administration, Patient, IMC, Disease, Biologics license application, Infection, Trial of the century, Immuron, Pharmaceutical industry

MELBOURNE, Australia, March 07, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim topline results confirming that a single daily dose of Travelan® is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC).

Key Points: 
  • This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study.
  • Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024.
  • To learn more about Phase 2 study design, read: U.S. Food and Drug Administration Step 3: Clinical Research
    IMM-124E (Travelan®) will be the first product developed with Immuron’s platform technology to proceed into Phase 3 clinical trials.
  • Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials.

MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic granulomatosis with polyangiitis (EGPA) with FASENRA

Retrieved on: 
Friday, February 23, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Metabolism, AstraZeneca, Hypereosinophilic syndrome, Chronic pain, Growth, Skin, Fatigue, Immunology, Polyp (medicine), Efficacy, COPD, Biopharmaceutical, Social media, Placebo, Safety, Treatment, Chronic obstructive pulmonary disease, ClinicalTrials.gov, Abstract (summary), Respiratory Medicine, OCS, Bell, Rash, Biomarker, Heart, HES, Sinusitis, Inflammation, Weight loss, Asthma, Gastrointestinal tract, Death, OLE, Disease, Pharmaceutical industry

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.

Key Points: 
  • AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.
  • Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA).
  • Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States.
  • A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON).

AppliedVR and Kernel Flow Announce Clinical Results Evaluating How Brain Changes During Virtual Reality Treatment of Chronic Pain

Retrieved on: 
Thursday, February 8, 2024
VR, Placebo, Pain, Brain, Organization, Mindfulness, Chronic pain, Patient, Research, Medicine, Biomarker, Medical imaging

While participants in the RelieVRx and sham groups both experienced varying levels of pain relief after completing the eight-week treatment, researchers determined that participants in the RelieVRx group experienced enhanced brain activation coherence -- change that previously has been related to reduced pain -- from pre-to-post treatment. Those patients receiving the VR sham control demonstrated a decline in brain coherence. Additionally, those receiving treatment from the RelieVRx device achieved a slower breathing rate as compared to the sham VR group. These results suggest that active RelieVRx treatment can create physiological changes in the body and have an impact on coherent global brain activity.

Key Points: 
  • The research used AppliedVR's RelieVRx® medical device, an eight-week, skills-based program that helps chronic low back pain (CLBP) patients learn self-management skills, combined with Kernel Flow and FlowVR—a compact, affordable, TD-fNIRS brain measurement headset customized for use in VR—to measure brain hemodynamic changes associated with pain relief.
  • These results suggest that active RelieVRx treatment can create physiological changes in the body and have an impact on coherent global brain activity.
  • AppliedVR and Kernel plan to conduct clinical studies to uncover how RelieVRx as an intervention could drive certain physiological changes in breathing and brain patterns that have been linked to pain relief.
  • "This exciting research shows how our Kernel Flow technology can measure the brain and help quantify notoriously difficult to measure conditions," said Kernel CEO Ryan Field.

Anavex Life Sciences Provides an Update on Rett Syndrome Program

Retrieved on: 
Tuesday, January 2, 2024
DSM-IV codes, Lethargy, Șaeș, AVATAR, Rett syndrome, Caregiver, Microsoft Access, Research, Fragile X syndrome, Marketing, FDA, EMA, Data analysis, Disease, Somnolence, MD, Doctor of Philosophy, Clinical trial, Seizure, Orphan drug, Clinical Global Impression, European Medicines Agency, CHMP, Expanded access, Anxiety, Committee, Safety, Patient, Placebo, Real, RTT, Therapy, OLE, Fast Track, RWE, Pharmaceutical industry

NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders today reported topline results from the randomized, double-blind, placebo-controlled, Phase 2/3 EXCELLENCE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 30 mg ANAVEX®2-73 in 92 pediatric patients with Rett syndrome (RTT) between the ages of 5 through 17 years. Participants were randomized 2:1 (ANAVEX®2-73 [62 patients] to placebo [30 patients]) for 12 weeks, followed by a week 16 safety visit. As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.

Key Points: 
  • As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.
  • After 12 weeks, the study showed improvement on the key co-primary endpoint Rett Syndrome Behaviour Questionnaire (RSBQ), which is a detailed 45-item questionnaire for assessing multiple Rett syndrome characteristics by the patients’ caregivers.
  • As of today, some patients with Rett syndrome have been on ANAVEX®2-73-treatment for over 4 years, combined OLE and Compassionate Use Program.
  • In addition to Rett syndrome, Anavex is evaluating ANAVEX®2-73 in other neurodevelopmental disorders, including Fragile X syndrome, and in neurodegenerative disorders like Parkinson’s disease.

AEON Biopharma Completes Enrollment in Phase 2 Study of ABP-450 (prabotulinumtoxinA) for Preventive Treatment of Chronic Migraine

Retrieved on: 
Tuesday, December 12, 2023
AEON, Steps, Patient, Food, Migraine, FDA, Hope, Injection, Headache, Patent, Incidence, MMD, Safety, Placebo, OLE, Pharmaceutical industry

IRVINE, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced today completion of enrollment with the last patient first visit in the Phase 2 study of ABP-450 for the preventive treatment of chronic migraine. The Company expects to announce topline data in the third quarter of 2024.

Key Points: 
  • “We are excited to continue to successfully execute our clinical strategy with the completion of enrollment in the Phase 2 study of ABP-450 for chronic migraine.
  • The study has enrolled a total of 492 patients across approximately 50 sites in the United States, Canada and Australia.
  • To date, there have been 421 patients enrolled in the OLE study across the episodic and chronic migraine Phase 2 cohorts.
  • Chronic Migraine Program Next Steps - The Company expects to announce topline data from the study in the third quarter of 2024.