Orthostatic hypertension

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Blood pressure, Diagnosis, Tadalafil, Blood, Serotonin, Patient, Committee, Knowledge, Regulation, Prostacyclin, EMA, IRIS, Artery, Life expectancy, Heart failure, Orthostatic hypertension, European, Therapy, COMP, Heart, Safety, European Commission, Marketing, Pulmonary hypertension, Medicine, Pharmaceutical industry

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Key Points: 


Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Update on Favorable Legal and Regulatory Outcomes Clearing Path for Potential FDA approval of YUTREPIA™ (treprostinil) inhalation powder

Retrieved on: 
Monday, April 1, 2024
UTHR, District court, Pulmonary hypertension, United Therapeutics, NDA, Motion, Originality, Orthostatic hypertension, Therapy, Patent, PAH, FDA, Court, Hearing, Food

As a result, the U.S. Food and Drug Administration (FDA) is no longer enjoined from issuing final approval of Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.

Key Points: 
  • As a result, the U.S. Food and Drug Administration (FDA) is no longer enjoined from issuing final approval of Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.
  • We have submitted the judge’s order to the FDA and look forward to a decision from the FDA in the near future.
  • Our commercial team is fully prepared to launch YUTREPIA in both PAH and PH-ILD should the FDA grant final approval.
  • The FDA is now able to take final action on YUTREPIA’s amended NDA that seeks approval for both indications.

Aerovate Therapeutics to Present Patient Baseline Characteristics of the Phase 2b Portion of the Phase 2b/Phase 3 IMPAHCT Trial at the American Thoracic Society 2024 International Conference

Retrieved on: 
Wednesday, March 27, 2024
Conference, ATS, Patient, Inhalation, American Thoracic Society, Orthostatic hypertension, Therapy, Safety, Pharmaceutical industry

The presentation will provide baseline characteristics from patients enrolled in the dose-ranging Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial evaluating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension.

Key Points: 
  • The presentation will provide baseline characteristics from patients enrolled in the dose-ranging Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial evaluating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension.
  • “We look forward to presenting baseline characteristics of the Phase 2b portion of the IMPAHCT trial in our poster presentation at the upcoming ATS conference in May,” said Tim Noyes, Chief Executive Officer at Aerovate Therapeutics.
  • “These data will provide insight into the IMPAHCT patient population as we continue Phase 3 trial recruitment globally and expect to present top line Phase 2b data in June.”
    Details for the poster presentation are as follows:
    Abstract: Baseline characteristics from the IMPAHCT trial of AV-101, inhaled imatinib, in subjects with pulmonary arterial hypertension
    The poster abstract is available now on the 2024 ATS website.
  • The abstract includes data from 147 patients, and the poster presentation on May 21st will include baseline characteristics for all 202 Phase 2b patients.

Gyre Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
Hepatitis, KPMG, GNI, Cirrhosis, Patient, Chronic obstructive pulmonary disease, Sale, Coagulopathy, Ernst & Young, Idiopathic pulmonary fibrosis, Fibrosis, Therapy, COPD, Marketing, Partnership, Arthur Andersen, Audit committee, SAN, Safety, CVR, CHB, Fatty liver disease, Prevalence, Pharmacy, Hospital, Research, Acquisition, TGF, Pirfenidone, GAAP, Toxicity, Inflammation, Accounting, Entecavir, Loss, Orthostatic hypertension, IPF, Partner, NASH, Category 1, Pharmaceutical industry

Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.

Key Points: 
  • Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.
  • In October 2023, Gyre (formerly known as Catalyst Biosciences, Inc. (“Catalyst”)) completed the previously announced business combination with GNI Group Ltd. (“GNI”) and related entities.
  • In October 2023, Gyre Pharmaceuticals completed enrollment of its Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC.
  • Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
    Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

Orphan designation: imatinib Treatment of pulmonary arterial hypertension, 21/06/2021 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Diagnosis, Civil service commission, Enzyme, Prevalence, Cell, Disease, Patient, Committee, Cancer, EMA, IRIS, Imatinib, Orthostatic hypertension, Agency, European, COMP, European Commission, MDC, PAH, Marketing, FGK, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of pulmonary arterial hypertension (PAH) in the European Union on 21 June 2021.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Liquidia Corporation Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 13, 2024
Research, PRINT, SVB, Patient, Pulmonary hypertension, Sale, NDA, PTAB, Orthostatic hypertension, Promotion, Safety, Security, PAH, FDA, Food, Cryptocurrency

ET

Key Points: 
  • ET
    MORRISVILLE, N.C., March 13, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the full year ended December 31, 2023.
  • ET to discuss the 2023 financial results and provide a corporate update.
  • In December 2023, the previous ruling by the Patent Trial and Appeal Board (PTAB) that all of the claims in U.S. Patent No.
  • The year ended December 31, 2023 included a $2.3 million loss on extinguishment of debt related to repayment of the A&R SVB LSA in January 2023.

FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)

Retrieved on: 
Tuesday, March 26, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, MSD, FC, Exercise, Breakthrough therapy, Blood, Risk, Patient, Orthostatic hypertension, MRK, World Health Organization, Heart, WHO, Multimedia, PAH, Food, Pharmaceutical industry

“The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.

Key Points: 
  • “The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.
  • In the WINREVAIR treatment group, the placebo-adjusted median increase in 6MWD was 41 meters (95% CI: 28, 54; p
  • The median treatment difference in PVR between WINREVAIR and placebo was -235 dynes*sec/cm5 (95% CI: -288, -181; p
  • The median treatment difference in NT-proBNP between WINREVAIR and placebo was -442 pg/mL (95% CI: -574, -310; p

Gossamer Bio Announces Appointment of Steven D. Nathan, M.D., and Skye Drynan to its Board of Directors

Retrieved on: 
Tuesday, March 12, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Pulmonary hypertension, Health care, Artificial intelligence, American Thoracic Society, Whitehead Institute, Lung transplantation, Idiopathic pulmonary fibrosis, Medical director, Biomedical Research, Pulmonology, Capital Group Companies, Gossamer, Partnership, American College, Wellesley College, American studies, Commerce, Creative, Medical education, Biomedicine, Latin American studies, International Society, Putnam Investments, MNTN, University, Senior, House, Publication, Portfolio manager, FDA, Internal medicine, Entrepreneurship, Lord Abbett, MIT, Capital, Bloomberg, GOSS, Orthostatic hypertension, IPF, Initial public offering, Partner, Idiopathic disease, PAH, Pharmaceutical industry

Skye Drynan is the Founder, CEO and Creative Director of House of Skye, Ltd., and a former Partner and Senior BioPharma Analyst at Capital Group.

Key Points: 
  • Skye Drynan is the Founder, CEO and Creative Director of House of Skye, Ltd., and a former Partner and Senior BioPharma Analyst at Capital Group.
  • Ms. Drynan joins the Board with an extensive background in finance, investment, and entrepreneurship, specializing in the biotechnology industry.
  • “The addition of Dr. Nathan to our Board signifies a pivotal moment in Gossamer’s evolution,” said Faheem Hasnain, Co-Founder, Chairman and CEO of Gossamer Bio.
  • Ms. Drynan is the Founder, CEO and Creative Director of House of Skye, Ltd., which she founded in 2016.

BIOTECHNOLOGY CEO AND INVENTOR OF SIRIUSXM SATELLITE RADIO MARTINE ROTHBLATT TO DELIVER GRADUATION ADDRESS TO THE UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE'S 215TH GRADUATING CLASS

Retrieved on: 
Thursday, March 28, 2024
International Bar Association, Astronomy, New York Hippodrome, Faculty, Biotechnology, Genome, Neuroblastoma, Patient, Human genome, Maryland School, University, Doctor of Philosophy, MD, Medical ethics, Dean, Federal Communications Commission, MBA, Radio, Human, Cancer, Orthostatic hypertension, Dentistry, Business Insider, Federal, Sirius XM, Therapy, UCLA, Physician, JD, Medicine

BALTIMORE, March 28, 2024 /PRNewswire/ -- University of Maryland School of Medicine (UMSOM) Dean Mark T. Gladwin, MD , announced today that Martine Rothblatt PhD, JD, MBA , Chairperson and CEO of United Therapeutics, and inventor of SiriusXM Satellite Radio, will deliver the keynote address for this year's graduating medical student class.

Key Points: 
  • BALTIMORE, March 28, 2024 /PRNewswire/ -- University of Maryland School of Medicine (UMSOM) Dean Mark T. Gladwin, MD , announced today that Martine Rothblatt PhD, JD, MBA , Chairperson and CEO of United Therapeutics, and inventor of SiriusXM Satellite Radio, will deliver the keynote address for this year's graduating medical student class.
  • The UMSOM MD graduation ceremony will take place at the Hippodrome Theatre on Thursday, May 16, 2024.
  • Dr. Rothblatt is a trailblazing pioneer of several innovations in biotechnology, pharmaceuticals, and satellite communications.
  • After developing SiriusXM, she founded United Therapeutics, in an effort to find a cure for her daughter's life-threatening illness, pulmonary arterial hypertension.

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Friday, March 22, 2024
Diagnosis, ESC, Toxicity, ERA, Tadalafil, Internal medicine, European Respiratory Society, Disease, Risk, Pulmonary hypertension, Patient, PVR, Mitigation, Female, Nitric oxide, Connective tissue disease, Orthostatic hypertension, World Health Organization, PDE5, Johnson & Johnson, REMS, WHO, Pulmonary circulation, PAH, FDA, Constriction, ERS, Food, Pharmaceutical industry

RARITAN, N.J., March 22, 2024  /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.1 OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.1

Key Points: 
  • Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available," said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.
  • The FDA's approval of OPSYNVI® is based on the results from the pivotal Phase 3 A DUE study , in which OPSYNVI® demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.
  • "People with PAH often live with the burden of taking many pills each day, which can pose challenges," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson.
  • "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."