Global Persistent Pulmonary Hypertension of the Newborn Pipeline Insight Report 2019 - ResearchAndMarkets.com - Business Wire
Global Persistent Pulmonary Hypertension of the Newborn Pipeline Insight Report 2019 - ResearchAndMarkets.com - Business Wire |
| Posted: 18 Oct 2019 04:32 AM PDT DUBLIN--(BUSINESS WIRE)--The "Persistent Pulmonary Hypertension of the Newborn Pipeline Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering. Persistent Pulmonary Hypertension of the Newborn Pipeline Insight, 2019 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Persistent Pulmonary Hypertension of the Newborn pipeline landscape is provided which includes the disease overview and Persistent Pulmonary Hypertension of the Newborn treatment guidelines. The assessment part of the report embraces, in depth Persistent Pulmonary Hypertension of the Newborn commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Persistent Pulmonary Hypertension of the Newborn collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Persistent Pulmonary Hypertension of the Newborn Pipeline Development Activities The report provides insights into different therapeutic candidates in discovery and preclinical, phase 1, phase 2, and phase 3 stage. Drugs under development as a monotherapy or combination therapy are also included. It also analyses key players involved in Persistent Pulmonary Hypertension of the Newborn targeted therapeutics development with respective active and inactive (dormant or discontinued) projects with the appropriate reasons if available. Persistent Pulmonary Hypertension of the Newborn pipeline report covers 2+ companies. Some of the key players include United Therapeutics Corporation (Treprostinil) etc. Persistent Pulmonary Hypertension of the Newborn Analytical Perspective In-depth Persistent Pulmonary Hypertension of the Newborn Commercial Assessment of products This report provides an in-depth Commercial Assessment of therapeutic drugs have been included which comprises of collaborations, Licensing, Acquisition -Deal Value Trends. The sub-segmentation is described in the report which includes Company-Company Collaborations (Licensing/Partnering), Company-Academia Collaborations, and Acquisition analysis in both Graphical and tabulated form. Persistent Pulmonary Hypertension of the Newborn Clinical Assessment of products The report comprises of comparative clinical assessment of products by development stage, product type, route of administration, molecule type, and MOA type across this indication. Scope of the report
Key Topics Covered: 1. Report Introduction 2. Persistent Pulmonary Hypertension of the Newborn 2.1. Persistent Pulmonary Hypertension of the Newborn Disease Overview 2.2. Persistent Pulmonary Hypertension of the Newborn History 2.3. Persistent Pulmonary Hypertension of the Newborn Symptoms 2.4. Persistent Pulmonary Hypertension of the Newborn Causes 2.5. Persistent Pulmonary Hypertension of the Newborn Pathophysiology 2.6. Persistent Pulmonary Hypertension of the Newborn Diagnosis 2.6.1. Diagnostic Guidelines 3. Persistent Pulmonary Hypertension of the Newborn Current Treatment Patterns 3.1. Treatment Guidelines 4. Persistent Pulmonary Hypertension of the Newborn - An Analytical Perspective 4.1. In-depth Commercial Assessment 4.1.1. Persistent Pulmonary Hypertension of the Newborn companies collaborations, Licensing, Acquisition -Deal Value Trends 4.1.1.1. Assessment Summary 4.1.2. Persistent Pulmonary Hypertension of the Newborn Collaboration Deals 4.1.2.1. Company-Company Collaborations (Licensing/Partnering) Analysis 4.1.2.2. Persistent Pulmonary Hypertension of the Newborn Acquisition Analysis 4.2. Clinical Assessment of Pipeline Drugs 4.2.1. Assessment by Phase of Development 4.2.2. Assessment by Product Type (Mono/Combination) 4.2.2.1. Assessment by Stage and Product Type 4.2.3. Assessment by Route of Administration 4.2.3.1. Assessment by Stage and Route of Administration 4.2.4. Assessment by Molecule Type 4.2.4.1. Assessment by Stage and Molecule Type 4.2.5. Assessment by MOA 4.2.5.1. Assessment by Stage and MOA 5. Persistent Pulmonary Hypertension of the Newborn Pipeline Therapeutics 5.1. Late Stage Products (Phase-III) 5.1.1. Comparative Analysis 5.2. Mid Stage Products (Phase-II) 5.3. Early Stage Products (Phase-I) 5.4. Pre-clinical and Discovery Stage Products 5.5. Inactive Products 6. Persistent Pulmonary Hypertension of the Newborn -Products Analysis 6.1. Product Profiles 6.1.1. United Therapeutics Corporation (Treprostinil) 6.1.1.1. Product Description 6.1.1.1.1. Product Overview 6.1.1.1.2. Mechanism of Action 6.1.1.2. Research and Development 6.1.1.2.1. Clinical Studies 6.1.1.2.1.1. Detailed Study Description 6.1.1.2.1.2. Study Results 6.1.1.2.1.3. Clinical Trials: Tabular View 6.1.1.3. Product Development Activities 6.1.1.3.1. Tabulated Product Summary 6.1.1.3.1.1. General Description Table 7. Recent Technologies 8. Persistent Pulmonary Hypertension of the Newborn Key Companies 8.1. United Therapeutics Corporation 8.2. Mallinckrodt 9. Persistent Pulmonary Hypertension of the Newborn Key Products 9.1. Treprostinil 9.2. Nitric oxide 10. Dormant and Discontinued Products 10.1. Dormant Products 10.1.1. Reasons for being dormant 10.2. Discontinued Products 10.2.1. Reasons for the discontinuation 11. Persistent Pulmonary Hypertension of the Newborn- Unmet Needs 12. Persistent Pulmonary Hypertension of the Newborn- Future Perspectives 13. Appendix Companies Mentioned
For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/5mqaew  | |
| Posted: 22 Oct 2019 12:00 AM PDT 
NEW ORLEANS — Combination therapy consisting of once-daily macitentan and tadalafil was associated with reductions in pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH), according to research findings presented at the CHEST Annual Meeting 2019, held October 19 to 23, 2019, in New Orleans, Louisiana. The presented research included findings from the prospective, multicenter, single-arm, open-label, phase 4 OPTIMA (ClinicalTrials.gov Identifier: NCT02968901) trial. Patients in the study had newly diagnosed PAH, were in World Health Organization functional class 2 and 3, and had no history of prior PAH therapy. The study treatment consisted of once-daily macitentan 10 mg and once-daily tadalafil 20 mg, with the tadalafil dose increasing to 40 mg after 8±3 days. The primary end point included reduction in mean PVR, which was assessed at week 16. Safety was also assessed for the 16 weeks until study termination. During the trial, the median duration of exposure to macitentan and tadalafil was 605.5 days. In the 46 patients who were enrolled and treated in OPTIMA, there was a 47% reduction in the mean PVR at 16 weeks compared with baseline (geometric mean ratio, 0.53; 95% CI, 0.47-0.59; p2.5 L/min/m2; mean right atrial pressure, 440 m; NT-proBNP, 65%). "Observing a PVR reduction of this magnitude is clinically meaningful," study investigator Olivier Sitbon, MD, of Bicêtre Hospital in Paris, France, told Pulmonology Advisor, "as PVR is a key marker of disease severity in PAH." There was also a substantial increase in the percentage of patients meeting ≥3 low-risk criteria from baseline to week 16 (23.9% to 68.2%, respectively). The majority of patients (93.5%) experienced ≥1 adverse event (AE), with 28.3% (n=13) of patients reporting serious AEs. A total of 3 patients discontinued treatment due to AEs, and 3 patients died during the trial. Causes of mortality included cardiac arrest, heart failure, and multiorgan failure with sepsis. The most frequently occurring AEs included peripheral edema (n=13), headache (n=11), diarrhea (n=9), dyspnea (n=7), anemia (n=6), and asthenia (n=6). Study limitations included the small sample size, short follow-up duration, and lack of a comparator group. According to Dr Sitbon, all patients in the OPTIMA study have been enrolled in an open-label extension study, UMBRELLA (ClinicalTrials.gov Identifier: NCT03422328), to assess safety. Dr Sitbon concluded that the data from the OPTIMA trial support the use of macitentan as part of a combination regimen in patients with PAH and add to the body of evidence supporting combination therapy as the standard of care. Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors' disclosures. Reference Sitbon O, Canuet M, Picard F, et al. Initial treatment combination with macitentan and tadalafil in patients with pulmonary arterial hypertension: results from the OPTIMA study. Presented at: CHEST Annual Meeting 2019; October 19-23, 2019; New Orleans, LA. Abstract 870.  |
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