PDE4

MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Treatment of ALS

Retrieved on: 
Monday, December 13, 2021
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Once issued, the patent maturing from this allowed patent application is expected to expire no earlier thanNovember 2035.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier thanNovember 2035.
  • Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer ofMediciNova, Inc., commented, "We are very pleased to receive notice that this new patent will be granted.
  • Once this new patent is granted, we will have three different U.S. patents that cover MN-166 for the treatment of ALS.
  • We believe it could substantially increase the potential value of MN-166 as it further strengthens our patent portfolio for ALS.

vTv Therapeutics Announces Restructuring to Prioritize its Lead Program and Focus Operations

Retrieved on: 
Monday, December 6, 2021
Pancreatic cancer, VTV, Risk, Projection, Terminology, Company, GLOBE, Review, SEC, Growth, Ketoacidosis, Hypoglycemia, Quality of life, Â, Patient, Therapy, Map, Psoriasis, Diabetes, Chronic obstructive pulmonary disease, Consultant, Continuous erythropoietin receptor activator, Adult, Breakthrough therapy, Autoimmune disease, PDE4, Program, FDA, Kidney, Nasdaq, Annual report, Investment, Pharmaceutical industry

HIGH POINT, N.C., Dec. 06, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for diabetes, today announced the prioritization of its lead program TTP399 as it gears up for Phase 3 pivotal trials.

Key Points: 
  • Type 1 Diabetes (T1D) is an autoimmune disease with no cure affecting over 1.6 million people today in the United States.
  • It is always difficult to restructure but this allows us to focus on TTP399 and our future growth, said Deepa Prasad, President and Chief Executive Officer of vTv Therapeutics.
  • vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company committed to improving the lives of diabetes patients by developing oral, small molecule drug candidates.
  • vTv has a pipeline of clinical drug candidates led by its program for the treatment of type 1 diabetes.

Global PDE Inhibitors Pipeline Insight Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 2, 2021
Health, Clinical Trials, News, COPD, Discovery, Psoriasis, Chronic obstructive pulmonary disease, Technology, Inflammation, Acquisition, PDE4, Route, Phosphodiesterase, Dermatology, Clinical trial, Route of administration, Therapy, ROA, PDE3, Atopic dermatitis, Chronic, Administration, NDA, FDA, Enzyme, Dermatitis, Pharmaceutical industry

This report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in PDE Inhibitors pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in PDE Inhibitors pipeline landscape.
  • A detailed picture of the PDE Inhibitors pipeline landscape is provided which includes the disease overview and PDE Inhibitors treatment guidelines.
  • The assessment part of the report embraces, in depth PDE Inhibitors commercial assessment and clinical assessment of the pipeline products under development.
  • PDE Inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Cerevel Therapeutics Reports Third Quarter 2021 Financial Results and Pipeline Updates

Retrieved on: 
Wednesday, November 10, 2021
Lists of diseases, Maintenance, Therapy, Anxiety, PET, PD, Epilepsy, Positive, Clinical trial, CO2, Food and Drug Administration, KORA, Terminology, Food, Growth, D, Exercise, COVID-19, GABAA, Research, Schizophrenia, SUD, PAM, Forward-looking statement, ID, Lists of Palestinian rocket attacks on Israel, Intention, Conference call, PDE4D, PANSS, Biotechnology, GLOBE, Annual general meeting, Brain, SEC, Patient, Inhalation, PDE4, FDA, American College, Total, IND, Pharmaceutical industry, Residential care

CAMBRIDGE, Mass., Nov. 10, 2021 (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 quarter ended September 30, 2021 and provided key pipeline and business updates.

Key Points: 
  • ET
    CAMBRIDGE, Mass., Nov. 10, 2021 (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 quarter ended September 30, 2021 and provided key pipeline and business updates.
  • In June 2021, Cerevel announced positive topline data for its Phase 1b trial of CVL-231 in people with schizophrenia.
  • Cerevel will present additional PK and pharmacodynamic (PD) data at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2021.
  • ET to discuss its third quarter 2021 financial results and pipeline updates.

Arcutis Announces Third Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 4, 2021
Janus, NDA, Dermatology, G&A, Scalp, R, Merck, CEO, JAK1, Food, Standard of care, Psoriasis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Shionogi, Vitiligo, Twitter, Company, Research, GLOBE, LinkedIn, Disease management, U.S. Securities and Exchange Commission, SEC, Skin, Nasdaq, Patient, Atopic dermatitis, Dermatitis, PDE4, FDA, Drug development, Cryptocurrency, Pharmaceutical industry, Lithium

(Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today reported financial results for the quarter ended September30, 2021, and provided a business update.

Key Points: 
  • (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today reported financial results for the quarter ended September30, 2021, and provided a business update.
  • We look forward to a transformative 2022 for Arcutis, with a potential launch in plaque psoriasis and three additional Phase 3 clinical data readouts anticipated.
  • The year-over-year increase for the quarter ended September30, 2021 was primarily due to higher headcount and professional services expenses.
  • General and administrative (G&A) expenses for the quarter ended September30, 2021 were $16.5 million compared to $5.6 million for the corresponding period in 2020.

UNION therapeutics receives FDA Fast Track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis

Retrieved on: 
Thursday, November 4, 2021
Safety, US Foods, KOL, MD, Skin, HS, Sleep, PDE4, UNION, Disease, Fast Track, Patient, Psoriasis, FDA, Food, A/S, Review, Infection, Atopic dermatitis, Adult, MPH, AD, Therapy, Population, Pharmaceutical industry

The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need.

Key Points: 
  • The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need.
  • Kim Kjller, Chief Executive Offer of UNION therapeutics said:
    "We are very pleased to receive this Fast Track designation for oral orismilast and look forward to working closely with the FDA.
  • We believe that oral orismilast holds great promise and has the potential to become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis without the safety issues associated with oral corticosteroids."
  • It is encouraging to see that FDA recognizes the potential of orismilast in atopic dermatitis and grants it fast track designation, which would bring orismilast one step closer to patients."

UNION therapeutics receives FDA Fast Track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis

Retrieved on: 
Thursday, November 4, 2021
Safety, US Foods, KOL, MD, Skin, HS, Sleep, PDE4, UNION, Disease, Fast Track, Patient, Psoriasis, FDA, Food, A/S, Review, Infection, Atopic dermatitis, Adult, MPH, AD, Therapy, Population, Pharmaceutical industry

The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need.

Key Points: 
  • The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need.
  • Kim Kjller, Chief Executive Offer of UNION therapeutics said:
    "We are very pleased to receive this Fast Track designation for oral orismilast and look forward to working closely with the FDA.
  • We believe that oral orismilast holds great promise and has the potential to become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis without the safety issues associated with oral corticosteroids."
  • It is encouraging to see that FDA recognizes the potential of orismilast in atopic dermatitis and grants it fast track designation, which would bring orismilast one step closer to patients."

MediciNova Announces New Data regarding MN-166 (ibudilast) in Glioblastoma to be Presented at the Annual Meeting of the Society for Neuro-Oncology

Retrieved on: 
Wednesday, November 3, 2021
Form 8-K, PDE4, Idiopathic pulmonary fibrosis, Fatty liver disease, Annual report, Neurodegeneration, Failure, MIF, Code, Security (finance), Substance dependence, U.S. Securities and Exchange Commission, Patient, NASDAQ, Private Securities Litigation Reform Act, FDA, Society, CIPN, Multiple sclerosis, SNO, Acute respiratory distress syndrome, MS, Chemotherapy-induced peripheral neuropathy, Risk, Tokyo Stock Exchange, Medicine, Cleveland Clinic, Glioblastoma, Amyotrophic lateral sclerosis, Form 10-K, IPF, DCM, NASH, Research, Intellectual property, GLOBE, ALS, Nasdaq, Pharmaceutical industry

In addition, MN-166 (ibudilast) is being evaluated in patients at risk for developing acute respiratory distress syndrome (ARDS).

Key Points: 
  • In addition, MN-166 (ibudilast) is being evaluated in patients at risk for developing acute respiratory distress syndrome (ARDS).
  • MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases.
  • Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development.
  • These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029.

UNION therapeutics announces enrollment of first patient in the OSIRIS Phase 2a study of oral orismilast for the treatment of mild to severe hidradenitis suppurativa

Retrieved on: 
Thursday, October 14, 2021
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HELLERUP, Denmark, Oct. 14, 2021 /PRNewswire/ -- UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced the enrollment of the first patient in OSIRIS, a Phase 2, open-label, proof of concept study of an oral tablet formulation of orismilast in adult patients with mild, moderate, and severe HS. The primary objective of OSIRIS is to explore evidence of efficacy of oral orismilast in the treatment of patients with HS for up to 16 weeks. Orismilast is currently in Phase 2 of clinical development for various inflammatory skin diseases, including psoriasis and atopic dermatitis.

Key Points: 
  • The primary objective of OSIRIS is to explore evidence of efficacy of oral orismilast in the treatment of patients with HS for up to 16 weeks.
  • Orismilast is currently in Phase 2 of clinical development for various inflammatory skin diseases, including psoriasis and atopic dermatitis.
  • The study will enroll 24 adult patients (men and women); 8 with mild, 8 with moderate, and 8 with severe HS.
  • Treatment for HS patients typically includes topical, oral or intravenous antibiotic treatment, which often provide only temporary symptomatic relief.

UNION therapeutics announces enrollment of first patient in the OSIRIS Phase 2a study of oral orismilast for the treatment of mild to severe hidradenitis suppurativa

Retrieved on: 
Thursday, October 14, 2021
Patient, Bandage, Publication, Man, Overalls, Pain, Abscess, Adult, Department, A/S, Cardiovascular disease, PHASE 2, Woman, Mortality, Zealand University Hospital, Roskilde, Therapy, Infection, Disease, Hidradenitis suppurativa, Inflammation, Scar, Chronic pain, PDE4, UNION, D, Quality of life, Social isolation, Psoriasis, HS, Safety, Research, Atopic dermatitis, Hope, Drainage, Skin, Boil, Pharmaceutical industry

The primary objective of OSIRIS is to explore evidence of efficacy of oral orismilast in the treatment of patients with HS for up to 16 weeks.

Key Points: 
  • The primary objective of OSIRIS is to explore evidence of efficacy of oral orismilast in the treatment of patients with HS for up to 16 weeks.
  • Orismilast is currently in Phase 2 of clinical development for various inflammatory skin diseases, including psoriasis and atopic dermatitis.
  • The study will enroll 24 adult patients (men and women); 8 with mild, 8 with moderate, and 8 with severe HS.
  • Treatment for HS patients typically includes topical, oral or intravenous antibiotic treatment, which often provide only temporary symptomatic relief.