Adverse

Current constipation medications don't provide relief for some patients with Chronic Idiopathic Constipation, per Gastroenterologist survey

Retrieved on: 
Tuesday, April 9, 2024
Adverse, Laxative, Gastrointestinal disease, Defecation, Patient, Human, American Journal, Weight loss, Constipation, News, Quality of life, Vibrant consonant, Hope, Invention, FDA

The survey of roughly 100 high-volume gastroenterology providers found that 74 percent of those interviewed are either unsure or positive that the medications they prescribe for patients with chronic constipation are not working.

Key Points: 
  • The survey of roughly 100 high-volume gastroenterology providers found that 74 percent of those interviewed are either unsure or positive that the medications they prescribe for patients with chronic constipation are not working.
  • Disrupting the U.S. $4.6 billion constipation treatment market, Vibrant Gastro’s first-in-class technology offers providers and patients with a new, non-pharmaceutical alternative to address this issue.
  • Patients track the progress of the treatment on their phone with an app to increase compliance, consistency and to monitor results.
  • A study presented at Digestive Disease Week in 2023 found significant symptomatic relief in patients and a substantially improved quality of life.

Leading FDA Compliance Specialist Offers Cosmetic Companies a Simpler Way To Manage Adverse Event Reporting Requirements

Retrieved on: 
Thursday, September 28, 2023
Food, Marketing, Adverse, Cosmetics, QR, Entrepreneurship, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Dietary supplement, Medical device, Pharmaceutical industry, Software

HAMPTON, Va., Sept. 28, 2023 /PRNewswire/ -- Registrar Corp, the leading regulatory compliance services, training, and software firm has introduced their new Adverse Event Reporting software to help cosmetic companies simplify FDA requirements.

Key Points: 
  • New Adverse Event Reporting software and services help save cosmetic companies time and effort in complying with updated FDA regulations.
  • HAMPTON, Va., Sept. 28, 2023 /PRNewswire/ -- Registrar Corp , the leading regulatory compliance services, training, and software firm has introduced their new Adverse Event Reporting software to help cosmetic companies simplify FDA requirements.
  • Registrar Corp's Adverse Event Reporting Software saves companies both time and effort by helping them comply with FDA.
  • "With this historic change to industry regulations, cosmetic companies are now required to collect, maintain, and submit reports on adverse events to FDA.

AstaLynx Global Announces Growing Prominence of Adverse Event Signal Detection Platform

Retrieved on: 
Tuesday, June 20, 2023
Deep learning, Natural language processing, Risk management, Adverse, NLP

NEW YORK, June 20, 2023 /PRNewswire/ -- AstaLynx Global is pleased to announce the growing prominence of its proprietary signal detection and management system, ADRium-Signals™.

Key Points: 
  • NEW YORK, June 20, 2023 /PRNewswire/ -- AstaLynx Global is pleased to announce the growing prominence of its proprietary signal detection and management system, ADRium-Signals™.
  • Over the last 12 months, ADRium-Signals has replaced two of the top leading legacy signal detection systems at several midsize pharmaceutical companies.
  • We envision building a platform that is capable of proactive safety monitoring - being able to predict Adverse Events before they happen," said Tarun Prashanth, CEO of AstaLynx.
  • In addition to offering signal detection and management technology via ADRium-Signals, AstaLynx provides end to end Pharmacovigilance services including case processing, aggregate reporting, signal detection and risk management, executed by their expert team of medical reviewers, safety scientists, and drug safety professionals.

Renewi plc: Annual Report and Accounts 2023

Retrieved on: 
Saturday, May 27, 2023
Workforce, Pressure, Climate, Injury, Crime, Public opinion, Bank statement, Policy, Annual, Health, Innovation system, Company register, Wind, ICT, Transparency, Annual report, Registrar of Companies (India), DTR, Knowledge, Disclosure, Companies Act 1985, Companies Act 2006, Adverse, Safety, Insurance, Retail, Bank, Civil engineering, Risk management, Audit, Renewi

The following additional information, summarised from the Renewi plc Annual Report and Accounts 2023, is disclosed in accordance with Disclosure and Transparency Rule 6.3.5.

Key Points: 
  • The following additional information, summarised from the Renewi plc Annual Report and Accounts 2023, is disclosed in accordance with Disclosure and Transparency Rule 6.3.5.
  • The 2023 Annual Report contains a responsibility statement in compliance with DTR 4.1.12.
  • Statutory accounts for 2021/22 have been delivered to the Registrar of Companies and those for 2022/23 will be delivered following the Company's Annual General Meeting on 13 July 2023.
  • The changes to the Board of Directors of Renewi plc since the 2022 Annual Report are:
    A list of current directors is maintained on the Renewi plc website: www.renewi.com.

Synlogic Announces Data Presentations at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting

Retrieved on: 
Monday, March 20, 2023
DSM-IV codes, Society, University of Pittsburgh, University, Pediatrics, Therapy, Phenylketonuria, SIMD, Aes, Adverse, AbbVie, Publication, Biomarker, Doctor of Philosophy, CBS, PKU, Research and development, Homocysteine, Plasma, Homocystinuria, Genetics, HCU, MD, Patient, Nature, Met, Annual general meeting, HCY, Extrapyramidal system, UPMC, Cystathionine, Synthetic biology, Medical genetics, Pharmaceutical industry, Dietary supplement, Research

In separate poster presentations, the company also presented clinical data and preclinical data related to its homocystinuria (HCU) program.

Key Points: 
  • In separate poster presentations, the company also presented clinical data and preclinical data related to its homocystinuria (HCU) program.
  • “We were delighted to review these encouraging findings from our two rare metabolic disease programs among the expert metabolic clinicians who attend the SIMD meeting,” said Dave Hava, Chief Scientific Officer and Head of Research and Development at Synlogic.
  • Clinical data presented included positive data from the Phase 1 study evaluating SYNB1353 in healthy volunteers using a dietary model of HCU.
  • Posters presented at the SIMD meeting are posted on the Publications page of the Synlogic website.

Wave Life Sciences Provides Positive Update on Proof-of-Concept Study for WVE-N531 in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, December 19, 2022
Clinical trial, Duchenne muscular dystrophy, MD, DMD, COVID-19, Dystrophin, MBA, Degenerative disease, PN, Pharmacology, Half-life, Plasma, BLQ, Webcast, Adverse, Human, RNA editing, Doctor of Philosophy, RNA, RT-PCR, Q&A, Vaccine, Wave

High muscle concentrations of WVE-N531 and exon skipping were observed six weeks after initiating biweekly multidosing at 10 mg/kg, achieving proof-of-concept in the study.

Key Points: 
  • High muscle concentrations of WVE-N531 and exon skipping were observed six weeks after initiating biweekly multidosing at 10 mg/kg, achieving proof-of-concept in the study.
  • “These data provide early evidence that WVE-N531 is working as intended, leading to substantial exon skipping after just three consecutive doses.
  • This is the earliest timepoint at which exon skipping has been reported in a clinical trial of boys with DMD,” said Anne-Marie Li-Kwai-Cheung, Chief Development Officer of Wave Life Sciences.
  • Following the live event, an archived version of the webcast will be available on the Wave Life Sciences website.

Provention Bio Announces Positive Final Results from First-In-Human Study of Coxsackievirus B Vaccine Candidate PRV-101

Retrieved on: 
Monday, March 28, 2022
Autoimmunity, Company, Risk, Pancreas, Regulation, Form 10-K, Degenerative disease, BANK, Fortis Healthcare, Adult, Annual report, News, Pregnancy, Program, VNT, Incidence, Adverse, RED, Immunity, U.S. Securities and Exchange Commission, Security (finance), Safety, Lupus, Twitter, Disclosure, Lists of diseases, Nasdaq, COVID-19, Infection, CRST, Patient, Volunteering, Mother, Vaccine, Pharmaceutical industry, T1D, CVB

RED BANK, N.J., March 28, 2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced positive results from the final analysis of its first-in-human PROVENT study of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate targeting all key CVB strains associated with type 1 diabetes (T1D) autoimmunity. Provention is developing PRV-101 for the prevention of acute CVB infection and its complications, as well as for the potential delay or prevention of associated autoimmune disorders T1D and celiac disease.

Key Points: 
  • PROVENT is a Phase 1 placebo-controlled, double-blind, randomized first-in-human study conducted at the Clinical Research Services Turku - CRST Oy, a clinical trial unit in Turku, Finland.
  • "These final results from this first-in-human trial of PRV-101 are extremely encouraging," said Francisco Leon, M.D., Ph.D., chief scientific officer and co-founder of Provention Bio.
  • Provention Bio, Inc. uses its website, www.proventionbio.com , as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D.
  • As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

Health Canada Authorizes Booster Dose of Moderna’s COVID-19 Vaccine in Individuals 18 Years of Age and Older

Retrieved on: 
Monday, November 15, 2021
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Chills, Milk, Government of Canada, Degenerative disease, AEFI, Pregnancy, Private Securities Litigation Reform Act, Syncope, Inc., Person, RNA transfection, Government, Severe acute respiratory syndrome coronavirus 2, U.S. Securities and Exchange Commission, Health Canada, Infection, Allergy, RNA, Swelling, Ageing, Arthralgia, Immunization, Profile, Vaccine, COVID-19, Data analysis, COVID-19 vaccine, Annual report, Fatigue, Intention, Science, Association, Myocarditis, Myalgia, Headache, Biotechnology, Pain, Vaccine-associated enhanced respiratory disease, Therapy, History, Pericarditis, SEC, Fever, Anaphylaxis, Appropriation, Vaccination, Adverse, Public Health Unit, Erythema, Pharmaceutical industry, Birth control

Notably, a booster dose of mRNA-1273 at the 50 g dose level boosted neutralizing titers significantly above the Phase 3 benchmark.

Key Points: 
  • Notably, a booster dose of mRNA-1273 at the 50 g dose level boosted neutralizing titers significantly above the Phase 3 benchmark.
  • After a booster dose, a similar level of neutralizing titers was achieved across age groups including in older adults (ages 65 and above).
  • The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.
  • Individuals who have received one dose of SPIKEVAX should receive a second dose of SPIKEVAX to complete the vaccination series.

Actinium Announces Multiple Abstracts Highlighting Iomab-B and Actimab-A Accepted for Presentation at the 63rd Annual American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 4, 2021
ACT, CD19, 2021 Essex County Council election, Radiation, Annual report, Cellular, AWE, Partnership, BMT, U.S. Securities and Exchange Commission, Patient, Security (finance), FDA, NYSE, SEC, Relapse, ARC, ASH, Adverse, Adoptive cell transfer, ARCS, Antibody, Company, CEO, Safety, Randomness, AML, Transplant, Toxic epidermal necrolysis, Form 10-Q, Society, Pharmaceutical industry, Medical device

Specifically, with Iomab-B we look forward to presenting the interim data update from full trial enrollment at ASH prior to top line results in 2022.

Key Points: 
  • Specifically, with Iomab-B we look forward to presenting the interim data update from full trial enrollment at ASH prior to top line results in 2022.
  • We are thrilled to have the opportunity to highlight the differentiated nature of our targeted radiotherapies in improving patient outcomes.
  • We look forward to show casing the latest data from these combination trials as well at ASH," said Sandesh Seth, Actinium's Chairman and CEO.
  • Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/
    Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

Trevena Announces Two OLINVYK® Presentations at ANESTHESIOLOGY® 2021

Retrieved on: 
Wednesday, October 13, 2021
Kidney, Naloxone, Incidence, Migraine, CKD, Epilepsy, Respiratory rate, Schedule 2, Trevena, BMI, FDA, Opioid use disorder, GLOBE, Schedule, Private Securities Litigation Reform Act, Trevena Inc, Risk, Research, Acute respiratory distress syndrome, Coronavirus Scientific Advisory Board (Turkey), Pennsylvania State University, PCA, Society, Company, Maintenance, Assistant, Obesity, TRV734, Oxygen saturation (medicine), Penn State Milton S. Hershey Medical Center, Senior, Pain, Ora Golan, Security (finance), SEC, Adverse, Central nervous system disease, Chronic kidney disease, RR, COVID-19, U.S. Securities and Exchange Commission, Central nervous system, Nobel Prize, CNS, ASA, American Society of Anesthesiologists, Safety, Pharmaceutical industry, Health insurance

CHESTERBROOK, Pa., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced two presentations at ANESTHESIOLOGY 2021, the national conference for the American Society of Anesthesiologists (ASA).

Key Points: 
  • CHESTERBROOK, Pa., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced two presentations at ANESTHESIOLOGY 2021, the national conference for the American Society of Anesthesiologists (ASA).
  • OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids.
  • Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders.
  • In addition, the forward-looking statements included in this press release represent the Companys views only as of the date hereof.