PBPK

Simulations Plus Reports Third Quarter Fiscal 2023 Financial Results

Retrieved on: 
Donnerstag, Juli 6, 2023
Software, Research, General Health, Professional Services, Pharmaceutical, Technology, Artificial Intelligence, Health Technology, Science, Biotechnology, Consulting, Health, SLP, Share repurchase, PBPK, Simulations Plus, QSP, Acquisition, Growth, EPS, ASR, Environment, Fiscal, Video game, Aquaculture, Bookkeeping

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical drug discovery and development, today reported financial results for its third quarter of fiscal 2023, ended May 31, 2023.

Key Points: 
  • Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical drug discovery and development, today reported financial results for its third quarter of fiscal 2023, ended May 31, 2023.
  • Strong execution on our strategic priorities this quarter resulted in profitable growth that keeps us on track to meet our stated goals for fiscal 2023.
  • Our clients are responding positively to this initiative, and we will continue the realignment process through the balance of 2023.
  • “As we enter the fourth quarter, our performance for the nine months gives us confidence in our previously stated guidance.

Simulations Plus Launches New Integrated Pulmonary Software and Services Package to Streamline Drug Development and Improve Patient Outcomes

Retrieved on: 
Mittwoch, Mai 10, 2023
Health Technology, Environmental, Social and Governance (ESG), Technology, Consulting, Pharmaceutical, Professional Services, Biometrics, Artificial Intelligence, Cardiology, Science, Biotechnology, Software, Other Science, Health, Research, Acceleration, SLP, PBPK, Simulations Plus, ILD, QSP, Patient, IPF, Idiopathic pulmonary fibrosis, Medical device

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of a new integrated pulmonary software and services package.

Key Points: 
  • Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of a new integrated pulmonary software and services package.
  • This targeted package will support pharmaceutical companies by streamlining their pulmonary drug development processes, enabling them to make better-informed decisions and bring therapies to market faster.
  • The pulmonary package offered by Simulations Plus is founded on the industry leading GastroPlus® modeling and simulation platform, which can be used to predict localized exposure in the lungs.
  • Together, we can better understand lung absorption and efficacy, and find new treatments for respiratory disease.”
    Learn more about the newly released pulmonary package: https://www.simulations-plus.com/breatheeasy

RedHill Publishes New Talicia® Data on Generic Non-Bioequivalence in AP&T and Presents New Dosing Data at Digestive Disease Week

Retrieved on: 
Dienstag, Mai 9, 2023
Helicobacter pylori, University, PBPK, TID, Rifabutin, AP, Stomach, DDW, Plasma, Public health, Hepatology, Data, University of Wisconsin School of Medicine and Public Health, Amoxicillin, Omeprazole, University of Tennessee Health Science Center, Genetically modified bacteria, Pharmacology, Therapy, Generic drug, Pharmaceutical industry, MD

RALEIGH, N.C. and TEL-AVIV, Israel, May 9, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced two distinct sets of new Talicia[3] data focused on generic non-bioequivalence and on dosing regimens. The first new dataset, published in the Journal Alimentary Pharmacology and Therapeutics (AP&T) showed that generically substituted regimens are non-bioequivalent to Talicia. The second set of data, presented at Digestive Disease Week (DDW), supports bioequivalence between Talicia TID (three times daily) and Q8H (every eight hours) dosing regimens for H. pylori eradication therapy.

Key Points: 
  • The first new dataset, published in the Journal Alimentary Pharmacology and Therapeutics (AP&T) showed that generically substituted regimens are non-bioequivalent to Talicia.
  • The second set of data, presented at Digestive Disease Week (DDW), supports bioequivalence between Talicia TID (three times daily) and Q8H (every eight hours) dosing regimens for H. pylori eradication therapy.
  • In eradicating H. pylori, previous work has shown the importance of antibiotic exposure at the site of the infection[4].
  • Given the potential for antibiotic resistance and treatment failure, the non-equivalence of generics shown by these data should be kept front of mind when prescribing first-line therapy for H. pylori eradication."

Simulations Plus Reports Second Quarter Fiscal 2023 Financial Results

Retrieved on: 
Mittwoch, April 5, 2023
Data Management, Health, Technology, Software, Artificial Intelligence, Pharmaceutical, Biotechnology, Fiscal, Biology, Consultant, Simulations Plus, Growth, EPS, EBITDA, Share repurchase, SLP, Total, PBPK, Video game, Aquaculture, Bookkeeping, Film industry

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today reported financial results for its second quarter of fiscal 2023, ended February 28, 2023.

Key Points: 
  • Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today reported financial results for its second quarter of fiscal 2023, ended February 28, 2023.
  • Shawn O’Connor, chief executive officer of Simulations Plus, said: “We were pleased to see revenue growth return in the second quarter, increasing 6% on a reported basis and 8% on a constant currency basis, as compared to the same period last year, with higher gross margins.
  • “As part of our updated capital allocation strategy that we detailed last quarter, we began our $20 million accelerated share repurchase program during the quarter, which we expect to complete during our third quarter.
  • We expect to continue to see results from our cross-selling efforts and the streamlining of our renewal process,” concluded O’Connor.

Gradient Receives Best Poster Award in the Medical Device and Combination Product Specialty Section in the Society of Toxicology Annual Meeting

Retrieved on: 
Donnerstag, März 30, 2023
Medical device, Society of Toxicology, Society, Database, PBPK, Skin, Best, SOT, Multimedia, DABT, Government, Gradient, Annual general meeting, Consumer Product Safety Act, Poster, Combination, Nursing

BOSTON, March 30, 2023 /PRNewswire/ -- The Society of Toxicology (SOT) Medical Device and Combination Product Specialty Section has given a Best Poster Award in the Medical Device and Combination Product Specialty Section to a poster co-authored by Gradient as part of the SOT 2023 Annual Meeting.  The winning poster, "Characterization of the ISO Database of Reference Chemicals for Interlaboratory Studies to Demonstrate the Applicability of OECD Methods to Assess Skin Sensitization of Medical Devices," was authored by Christian Pellevoisin, A. Nguyen, Ron Brown, Rose-Marie Jenvert, Hervé Groux, Peter Cornelis, Michelle H. Lee, Austin Zdawczyk, Joseph Carraway, Emma Pedersen, Joel Cohen, David Waeckerlin, Audrey P. Turley, Sebastian Hoffmann, and Kelly Coleman.  The poster was presented at SOT's 62nd Annual Meeting and ToxExpo in Nashville, Tennessee, earlier this month.

Key Points: 
  • BOSTON, March 30, 2023 /PRNewswire/ -- The Society of Toxicology (SOT) Medical Device and Combination Product Specialty Section has given a Best Poster Award in the Medical Device and Combination Product Specialty Section to a poster co-authored by Gradient as part of the SOT 2023 Annual Meeting.
  • The poster was presented at SOT's 62nd Annual Meeting and ToxExpo in Nashville, Tennessee, earlier this month.
  • One poster is selected to receive the Best Poster Award, Medical Device and Combination Products Specialty Section each year.
  • Any poster accepted for presentation in the section is eligible for the Best Poster Award.

Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

Retrieved on: 
Dienstag, März 7, 2023
Growth, FDA, MBI, Simulation, SVP, Pharmacokinetics, Trial of the century, QSP, LAI, PBPK, Lactation, Doctor of Philosophy, Drug development, Pregnancy, Excipient, Metabolism, Patient, Quantitative systems pharmacology, PD, Generic drug, Pharmaceutical industry, Simcyp, Pharmacodynamics, Certara

The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.

Key Points: 
  • The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.
  • The Simcyp Simulator has proven use cases across drug development, including first-in-human dosing, extrapolation to special populations, bioequivalence testing, optimizing clinical study design and predicting drug-drug interactions (DDIs).
  • “We are excited to expand and improve upon the Simcyp Simulator capabilities to advance modern drug development with the launch of our latest version,” said Masoud Jamei, Ph.
  • For more information about the Simcyp PBPK Simulator and Simcyp Designer, please visit: https://www.certara.com/software/simcyp-pbpk/

ScitoVation Announces ScitoSim™ - New Tool for PBPK Modeling

Retrieved on: 
Dienstag, Februar 28, 2023
OECD, Risk assessment, Medical imaging, PBPK

DURHAM, N.C., Feb. 28, 2023 /PRNewswire-PRWeb/ -- ScitoVation announced ScitoSim™, a new PBPK modeling tool. ScitoSim™ simulates time-course profiles and external-internal dose metric relationships using a companion library of published models including a generic PBPK model for different species. ScitoSim™ was developed for all users, not just programmers and well-versed kineticists.

Key Points: 
  • DURHAM, N.C., Feb. 28, 2023 /PRNewswire-PRWeb/ -- ScitoVation announced ScitoSim™, a new PBPK modeling tool.
  • ScitoSim™ simulates time-course profiles and external-internal dose metric relationships using a companion library of published models including a generic PBPK model for different species.
  • Andy Nong, ScitoVation's Director of Computational Toxicology, explains the differences between ScitoSim™ and other PBPK Modeling tools: "The streamlined app features a simplified interface and standardized reports based on OECD recommendations, said Nong.
  • Training in PBPK modeling and using the modeling tool for different exposure and risk assessment situations will also be provided.

RedHill Presents New Talicia® Data Analyses at Obesity Week 2022

Retrieved on: 
Freitag, November 4, 2022
Well, ACG, World, Obesity, Drug, Body mass index, World Health Organization, Ulcerative colitis, FDA, Population, TEL, WHO, Adult, Safety, MALT, PPI, Stomach, Gastroenterology, Nasdaq, Rifabutin, Division, Metabolism, Helicobacter pylori, BMI, Amoxicillin, ITT, Insulin, Clarithromycin, Risk, Prevalence, Overweight, Genetically modified bacteria, Diabetes, Duke University School of Medicine, Hypoglycemia, Omeprazole, PBPK, Pharmaceutical industry, Patient

RALEIGH, N.C. and TEL AVIV, Israel, Nov. 4, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the presentation of new Talicia® data analyses for the treatment of H. pylori, at the Obesity Week Annual Meeting, November 1-4, 2022.

Key Points: 
  • Published data have shown that both obesity and diabetes have been associated with failure of clarithromycin-based therapies for the treatment of H. pylori infection.
  • These analyses assessed the safety and efficacy of Talicia in achieving H. pylori eradication in patients who are either obese or have diabetes.
  • "Moreover, Talicia was shown to maintain high intragastric rifabutin concentrations regardless of patient obesity status, further supporting its use as a rational choice for empiric first-line therapy."
  • These data support the efficacy and safety of Talicia as empiric first-line treatment for H. pylori infection in patients regardless of obesity or diabetic status.

Simulations Plus and the University of Florida Awarded New FDA Contract to Support Development and Regulatory Assessment of Inhaled Products

Retrieved on: 
Mittwoch, November 2, 2022
Technology, FDA, Public Relations, Investor Relations, Communications, Software, Biotechnology, Health, Pharmaceutical, Data Management, Name, Software, Food and Drug Administration, Population, SLP, Kinetics, Independent agencies of the United States government, Human services, Simulations Plus, Method, Government, Partnership, Asthma, Research, Mission statement, Industry, U.S. Securities and Exchange Commission, Associate Director of National Intelligence and Chief Information Officer, Nasdaq, Program, Biophysical environment, Department, Economics, Cerebrospinal fluid, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cell, COPD, Technology, PBPK, University, IVIVC, Private Securities Litigation Reform Act, Company, Assistant, United States Department of Health and Human Services, FDA, Microfluidics, Pharmacokinetics, Patient, Food, ESG, Biotechnology, Drug discovery, Solution, Risk, Pharmaceutical industry, Medical device

The resulting outcome will provide the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for OIDPs.

Key Points: 
  • The resulting outcome will provide the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for OIDPs.
  • This partnership with Dr. Cristofoletti, his team, and the FDA will expand and improve upon our current cutting-edge technology.
  • FDA scientific and program staff will actively collaborate with the University of Florida and Simulations Plus.
  • We are very excited about the funding of this FDA contract that allows us to collaborate with Dr. Guenther Hochhaus, Dr. Jrgen Bulitta, and Simulations Plus, said Dr. Cristofoletti.

RedHill Presents New Talicia® and Movantik® Data Analyses at ACG 2022

Retrieved on: 
Mittwoch, Oktober 26, 2022
Quality of life, Stomach, Doctor of Philosophy, Constipation, Population, Rifabutin, Genetically modified bacteria, PPI, Patient, Feinberg School of Medicine, PAMORA, Division, Amoxicillin, Nasdaq, BID, WHO, University, ITT, World, ACG, Opioid, Ulcerative colitis, University of Tennessee Health Science Center, MALT, Adult, PBPK, World Health Organization, Helicobacter pylori, Clarithromycin, Omeprazole, OIC, American College, FDA, Redhill, QOL, Prescription, Pharmaceutical industry, Vaccine, Dentistry, Gastroenterology, MD, Northwestern University, Naloxegol

RALEIGH, N.C. and TEL-AVIV, Israel, Oct. 26, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the presentation of new data analyses for Talicia®, for the treatment of H. pylori, and Movantik®, for the treatment of opioid -induced constipation (OIC), at the American College of Gastroenterology Annual Meeting (ACG) October 21-26, 2022.

Key Points: 
  • This second Movantik poster evaluated the efficacy of Movantik in providing clinically meaningful symptom improvement, based on the PAC-SYM patient reported outcome, in patients with OIC.
  • In both analyses Movantik was well tolerated and demonstrated a favorable safety profile.
  • Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works.
  • [11] The pivotal Phase 3 study with Talicia demonstrated 84% eradication of H. pylori infection with Talicia vs. 58% in the active comparator arm (ITT analysis, p