Dioxolanes

14 - Alpha Demethylase Inhibitors Pipeline Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 8, 2021

The "14 - Alpha Demethylase Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "14 - Alpha Demethylase Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "14-alpha demethylase inhibitors - Pipeline Insight, 2021" report provides comprehensive insights about 12+ companies and 12+ pipeline drugs in 14-alpha demethylase inhibitors pipeline landscape.
  • This segment of the report provides insights about the different 14-alpha demethylase inhibitors drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.
  • 14-alpha demethylase inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV® (levoketoconazole) for the Treatment of Cushing’s Syndrome

Retrieved on: 
Thursday, June 3, 2021

11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.

Key Points: 
  • 11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.
  • 9,918,984, covers methods of treating Cushings syndrome with levoketoconazole and will expire on January 10, 2026.
  • RECORLEV is an adrenal steroidogenesis inhibitor with a New Drug Application that is currently under review by the U.S. Food and Drug Administration for the treatment of endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenous Cushing's syndrome.

Strongbridge Biopharma plc Announces Submission of New Drug Application for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the U.S. Food & Drug Administration

Retrieved on: 
Tuesday, March 2, 2021

The submission of the New Drug Application for RECORLEV (levoketoconazole) represents not only a significant milestone for Strongbridge but also for the Cushings syndrome community as a whole.

Key Points: 
  • The submission of the New Drug Application for RECORLEV (levoketoconazole) represents not only a significant milestone for Strongbridge but also for the Cushings syndrome community as a whole.
  • RECORLEV, the pure 2S,4R enantiomer of the enantiomeric pair comprising ketoconazole, is a next-generation steroidogenesis inhibitor being investigated as a chronic therapy for adults with endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenousCushing'ssyndrome.
  • ET to discuss the Companys fourth quarter and full-year 2020 financial results and recent corporate highlights, including the RECORLEV NDA submission.

TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial

Retrieved on: 
Tuesday, December 15, 2020

TFF Pharmaceuticals is conducting this Phase 1b clinical trial of Voriconazole Inhalation Powder in patients with asthma to assess the safety, pharmacokinetics, and induction of bronchospasm.

Key Points: 
  • TFF Pharmaceuticals is conducting this Phase 1b clinical trial of Voriconazole Inhalation Powder in patients with asthma to assess the safety, pharmacokinetics, and induction of bronchospasm.
  • Treatment of Voriconazole Inhalation Powder without induction of bronchospasm would allow for treatment of patients with IPA that have hyperreactive airway disease comorbidities to proceed without bronchodilator pretreatment.
  • TFF Pharmaceuticals is advancing development of Voriconazole Inhalation Powder towards a pivotal Phase 2 study to assess the efficacy of the dry powder formulation for the treatment of IPA.
  • TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder.

New Data On Mayne Pharma's Tolsura® (SUBA®-itraconazole) Presented At IDWeek 2020

Retrieved on: 
Monday, October 26, 2020

ADELAIDE, Australia, Oct. 26,2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that new clinical data has been presented on TOLSURA (SUBA-itraconazole) at IDWeek 2020, being held virtually in the US from October 21st-25th.

Key Points: 
  • ADELAIDE, Australia, Oct. 26,2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that new clinical data has been presented on TOLSURA (SUBA-itraconazole) at IDWeek 2020, being held virtually in the US from October 21st-25th.
  • The study results were presented by the study Principal Investigator, Professor Peter G. Pappas, MD.
  • As a controlled, head-to-head study, these data provide real-world clinical evidence of the utility of TOLSURA in endemic infections."
  • The oral presentations at IDWeek 2020 relating to TOLSURA are:
    Presenter Peter G. Pappas, MD.

INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer

Retrieved on: 
Monday, November 25, 2019

During that meeting, we gained FDA guidance and agreement on our protocol and statistical analysis plan for our proposed PREDICT trial.

Key Points: 
  • During that meeting, we gained FDA guidance and agreement on our protocol and statistical analysis plan for our proposed PREDICT trial.
  • FDA indicated that we can follow the 505(b)(2) regulatory pathway given previous FDA approval of itraconazole.
  • Clinical studies have shown SUBA-Itraconazole to have greater bioavailability than generic itraconazole, a drug approved by FDA for the treatment of certain fungal infections.
  • Based on published research, INHIBITOR believes that inhibiting the Hedgehog pathway could delay or possibly prevent development and progression of certain cancers, such as prostate cancer, in humans.

HedgePath Pharmaceuticals Provides Corporate Update for the Fourth Quarter and Year End 2018

Retrieved on: 
Thursday, March 7, 2019

HedgePath is focused on advancing its oral itraconazole-based drug candidate, SUBA-Itraconazole, for the treatment of advanced prostate and lung cancers in anticipated upcoming clinical studies.

Key Points: 
  • HedgePath is focused on advancing its oral itraconazole-based drug candidate, SUBA-Itraconazole, for the treatment of advanced prostate and lung cancers in anticipated upcoming clinical studies.
  • In 2018, HedgePath successfully completed Phase 2(b) trial studying the effects of SUBA-Itraconazole in patients with BCCNS.
  • "We believe our considerable efforts throughout 2018 position HedgePath positively for the future as we seek to augment the potential value of SUBA-Itraconazole," stated Nicholas J. Virca, President and Chief Executive Officer of HedgePath.
  • On December 17, 2018, HedgePath announced that it had entered into a revised Supply and License Agreement with Mayne Pharma.

Global Antifungal Drugs Market, 2013-2018 & 2023 - Increasing Popularity of OTC Drugs, Increase in Availability of Innovative Antifungals & Growing Prevalence of Candidiasis and Aspergillosis

Retrieved on: 
Monday, February 18, 2019

Global antifungal drugs market is projected to display a robust growth represented by a CAGR of 3.70% during 2018 - 2023.

Key Points: 
  • Global antifungal drugs market is projected to display a robust growth represented by a CAGR of 3.70% during 2018 - 2023.
  • Over the recent years, Antifungal Drugs market has been witnessing growth on account of several driving factors including growing prevalence of fungal infections such as candidiasis and aspergillosis, increasing popularity of over-the-counter drugs, and increase in availability of innovative antifungals.
  • By therapeutic indications, drugs use in the treatment of candidiasis are anticipated to creates their dominance in global antifungal drugs market.
  • Amongst the regions, North America accounts for the largest regional share in the global antifungal drugs market in 2017.

Global Antifungal Drugs Market is projected to display a robust growth represented by a CAGR of 3.70% during 2018 - 2023

Retrieved on: 
Wednesday, February 6, 2019

The report analyses the Antifungal Drugs Market By Drug Type (Azoles, Echinocandins, Polyenes, Others), By Therapeutic Indications (Candidiasis, Aspergillosis, Dermatophytosis, Others).

Key Points: 
  • The report analyses the Antifungal Drugs Market By Drug Type (Azoles, Echinocandins, Polyenes, Others), By Therapeutic Indications (Candidiasis, Aspergillosis, Dermatophytosis, Others).
  • By therapeutic indications, drugs use in the treatment of candidiasis are anticipated to creates their dominance in global antifungal drugs market.
  • Amongst the regions, North America accounts for the largest regional share in the global antifungal drugs market in 2017.
  • Global Antifungal Drugs Market (Actual Period: 2013-2017, Forecast Period: 2018-2023)
    Analysis By Drug Type - Azole Class Antifungal Drugs, Echinocandins Class Antifungal Drugs, Polyenes Class Antifungal Drugs, Other Class Antifungal Drugs
    Analysis By Therapeutic Indications - Aspergillus, Dermatophytosis, Candidiasis, Other Therapeutic Indications
    Regional Antifungal Drugs Market North America, Europe, Asia Pacific, Rest of the World (Actual Period: 2013-2017, Forecast Period: 2018-2023)
    Analysis By Drug Type - Azole Class Antifungal Drugs, Echinocandins Class Antifungal Drugs, Polyenes Class Antifungal Drugs, Other Class Antifungal Drugs
    Analysis By Therapeutic Indications - Aspergillus, Dermatophytosis, Candidiasis, Other Therapeutic Indications
    Analysis By Drug Type - Azole Class Antifungal Drugs, Echinocandins Class Antifungal Drugs, Polyenes Class Antifungal Drugs, Other Class Antifungal Drugs
    Analysis By Therapeutic Indications - Aspergillus, Dermatophytosis, Candidiasis, Other Therapeutic Indications
    Market Dynamics Drivers and Restraints.

TOLSURA (TM) (SUBA®-itraconazole) Antifungal Capsule Now Available in the United States

Retrieved on: 
Wednesday, January 30, 2019

ADELAIDE, Australia, Jan. 30, 2019 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of TOLSURA (SUBA-itraconazole) 65mg capsule in the United States.

Key Points: 
  • ADELAIDE, Australia, Jan. 30, 2019 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of TOLSURA (SUBA-itraconazole) 65mg capsule in the United States.
  • The Company received US Food and Drug Administration (FDA) approval for TOLSURA in December 2018.
  • TOLSURA provides a new treatment option for patients and physicians fighting these life-threatening fungal infections.
  • For more information about TOLSURA, please refer to the prescribing information available here .