PDE4

Palisade Bio Announces Positive Preclinical Data of Lead Program PALI-2108 at the 2024 Crohn’s & Colitis Congress

Retrieved on: 
Monday, January 29, 2024
Patient, Research, DSS, UC, Inflammatory bowel disease, DAI, Poster, PDE4, IBD, Dog, PDE4B, Plasma, AUC, Ulcerative colitis, Toxicity, Efficacy, Therapy, Vomiting, Absorption, Asian literature, Trial of the century, CNS, Pharmaceutical industry

Carlsbad, CA, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today announced the presentation of positive preclinical data of its lead asset, PALI-2108 at the Crohn’s & Colitis Congress, which was held on January 25-27, 2024 in Las Vegas, NV.

Key Points: 
  • The preclinical data was presented in a poster titled, Local Bioactivation and Efficacy of PALI-2108: A Promising PDE4 Inhibitor Prodrug for Ulcerative Colitis Treatment.
  • PALI-2108 is the Company’s orally administered, locally acting colon-specific phosphodiesterase-4B (PDE4B) inhibitor prodrug in development for patients affected by moderate-to-severely active ulcerative colitis (UC).
  • The poster is available on the Scientific Publications page of the Company’s website .
  • This feature ensures localized bioactivation, leading to colon-specific distribution with limited systemic exposure, as confirmed by a tissue distribution study.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Human medicines European public assessment report (EPAR): Daxas, roflumilast, Date of authorisation: 05/07/2010, Revision: 20, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Atmosphere, Patient, Liver, Medical Subject Headings, Diarrhea, Marketing, Agency, INN, ATC, Insomnia, COPD, International, Chronic obstructive pulmonary disease, European, Headache, Disease, Nausea, Language, FEV1, Abdominal pain, Gestational sac, Inflammation, Appetite, PDE4, Observational study, European Medicines Agency, Tablet, Chronic pain, Select, Bronchitis, Safety, Anatomy, IIA, History, Medical device

Human medicines European public assessment report (EPAR): Daxas, roflumilast, Date of authorisation: 05/07/2010, Revision: 20, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Daxas, roflumilast, Date of authorisation: 05/07/2010, Revision: 20, Status: Authorised

FDA Accepts Arcutis’ Supplemental New Drug Application for Roflumilast Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to Age 6

Retrieved on: 
Wednesday, November 29, 2023
Atopic dermatitis, Food, Adolescence, Shanda, FDA, PDUFA, Success, Prevalence, Disease, Pediatrics, Atopy, PDE4, Patient, Safety, Skin, Pharmaceutical industry

The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.

Key Points: 
  • The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.
  • “Atopic dermatitis is a chronic and recurring inflammatory skin condition that requires therapy that is effective, tolerable, and suitable for long-term use by both adults and children.
  • INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD.
  • The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Palisade Bio Reports Third Quarter 2023 Financial Results and Provides Business Outlook

Retrieved on: 
Friday, November 10, 2023
Ulcerative colitis, Doctor of Philosophy, Therapy, Safety, IBD, PDE4, UC, Palisade

Carlsbad, CA, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today reported its financial results for the third quarter 2023 and provided a business outlook.

Key Points: 
  • Carlsbad, CA, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today reported its financial results for the third quarter 2023 and provided a business outlook.
  • “The past quarter was marked by a transformative transaction for Palisade.
  • We believe that novel therapeutics which demonstrate safety and efficacy have the potential to gain significant market share.
  • Palisade has the only PDE4 inhibitor prodrug under development for the treatment of ulcerative colitis, our lead indication,” commented J.D.

Arcutis Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, November 3, 2023
Janus, FDA, Psoriasis, Research, JAK1, Patent, ESG, GTN, SG, Human, Acquisition, Environmental, social, and corporate governance, Biophysical environment, United States Patent and Trademark Office, Inflammation, Hair, R, Senior, Growth, Prescription, Marketing, Shanda, Webcast, SLR, New Drug Application, Scalp, PDE4, NDA, Atopic dermatitis, Patient, Dermatitis, Acceleration, Alopecia areata, Video game, Pharmaceutical industry, Security (finance), Fine chemical, Vaccine, Cosmetics

The Company anticipates further GTN improvement in the fourth quarter of 2023.

Key Points: 
  • The Company anticipates further GTN improvement in the fourth quarter of 2023.
  • In October 2023, Arcutis received FDA approval for ZORYVE for an expanded indication for the treatment of plaque psoriasis in children down to 6 years of age.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR Pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Arcutis management will host a conference call and webcast today at 8:30am ET to discuss the financial results for the quarter and provide a business update.

Cerevel Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, November 1, 2023
FDA, Research, Psychiatry, PIN, Hallucination, Tavapadon, PAM, DSM-IV codes, Conference, Exercise, Volunteering, Pharmacokinetics, GABAA, Panic disorder, Schizophrenia, Disorder, KORA, ADAPT, Delusion, PDE4, Brain, Safety, Epilepsy, Total, Therapy, Conference call, Broadcasting, Pharmaceutical industry, Cryptocurrency, Airline

CAMBRIDGE, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics, (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the third quarter ended September 30, 2023 and provided key pipeline and business updates.

Key Points: 
  • ET
    CAMBRIDGE, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics , (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the third quarter ended September 30, 2023 and provided key pipeline and business updates.
  • Leveraging its deep understanding of neurocircuitry and targeted receptor subtype selectivity, Cerevel is advancing its broad and diverse pipeline of novel neuroscience product candidates.
  • Cerevel is conducting the REALIZE trial, a Phase 2 proof-of-concept trial in focal epilepsy, and a corresponding open-label safety extension trial.
  • ET to discuss its third quarter 2023 financial results and key pipeline and business updates.

Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Friday, October 13, 2023
Congress, Pain, Scalp, PSD, Week, PDE4, Patient, Face, Pharmaceutical industry

The results, including new patient-reported outcome data, were presented at the EADV Congress held October 11-14, 2023, in Berlin.

Key Points: 
  • The results, including new patient-reported outcome data, were presented at the EADV Congress held October 11-14, 2023, in Berlin.
  • New data presented in Berlin demonstrate improvements in both scalp and body itch.
  • Importantly, a rapid and significant improvement in scalp itch was observed 24 hours following first application as measured by SI-NRS (P=0.0164).
  • Overall, the most common adverse events in the study population (≥2%) included headache (4.6%), diarrhea (3.2%), COVID-19 (2.8%), and nausea (2.1%).

Meiji Seika Pharma Presents Positive Findings from Phase II Study of ME3183, Novel Highly-Potent Selective PDE4 Inhibitor, in Patients With Plaque Psoriasis at EADV Congress 2023

Retrieved on: 
Friday, October 13, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Congress, European Association for the Study of the Liver, PASI, Meiji, BID, Outline, Safety, Psoriasis, Psoriasis Area and Severity Index, PDE4, QD, Traffic barrier, Patient, Pharmaceutical industry, Dermatology, Venereology

In total, 132 patients were randomly assigned to ME3183 (n=26, 26, 26, and 27, respectively) or placebo (n=27).

Key Points: 
  • In total, 132 patients were randomly assigned to ME3183 (n=26, 26, 26, and 27, respectively) or placebo (n=27).
  • Mean Psoriasis Area and Severity Index (PASI) score at baseline was 15.9–17.6 and 16.8 in the ME3183 and placebo groups, respectively.
  • In conclusion, ME3183 administered orally was effective in the treatment of plaque psoriasis and had an acceptable safety profile.
  • Meiji strives to provide efficacious and safe treatment for unmet medical needs, such as psoriasis and other autoimmune diseases.