Orthostatic hypertension

Liquidia Corporation Provides Update on New Drug Application for YUTREPIA™ (treprostinil) inhalation powder

Retrieved on: 
Thursday, January 25, 2024
United Therapeutics, CAFC, Patient, PAH, Patent, Originality, NYHA, District court, Functional, Food, NDA, Safety, Orthostatic hypertension, FDA, PTAB, New Drug Application, Exercise, PDUFA, UTHR, Pulmonary hypertension

The FDA informed the Company that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA.

Key Points: 
  • The FDA informed the Company that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA.
  • The FDA did not request any additional clinical data to support the NDA and did not issue a new PDUFA goal date.
  • As communicated by the tentative approval to treat PAH, YUTREPIA has already met the regulatory standards for quality, safety and efficacy.
  • In July 2023, Liquidia filed an amendment to its New Drug Application for YUTREPIA, seeking to add PH-ILD to the label.

Gossamer Bio Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, January 8, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, GOSS, Gossamer, Compensated emancipation, Orthostatic hypertension, Employment, PAH

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that the Compensation Committee of Gossamer’s Board of Directors approved the grant, effective January 5, 2024, to two new non-executive employees of non-qualified stock option awards to purchase up to an aggregate of 212,500 shares of the Company’s common stock under the Gossamer Bio, Inc. 2023 Employment Inducement Incentive Award Plan (“2023 Inducement Plan”).

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that the Compensation Committee of Gossamer’s Board of Directors approved the grant, effective January 5, 2024, to two new non-executive employees of non-qualified stock option awards to purchase up to an aggregate of 212,500 shares of the Company’s common stock under the Gossamer Bio, Inc. 2023 Employment Inducement Incentive Award Plan (“2023 Inducement Plan”).
  • The awards were granted as an inducement material to the employees entering into employment with Gossamer in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The options have an exercise price of $0.85 per share, which is equal to the closing price of Gossamer’s common stock as reported by The Nasdaq Global Select Market on January 5, 2024.
  • The options are subject to the terms and conditions of the 2023 Inducement Plan and the terms and conditions of a stock option agreement covering the grants.

VIVUS Provides Update on Pipeline and Program Milestones

Retrieved on: 
Monday, January 8, 2024
Patient, Quality of life, HIV/AIDS, Bloating, Diarrhea, Inflammatory bowel disease, ABPM, Chronic pain, Enzyme replacement therapy, Cystic fibrosis, Heart, Degenerative disease, Exocrine pancreatic insufficiency, Comorbidity, Steatorrhea, Obesity, HIV, Amylase, Orthostatic hypertension, Phentermine, Heart failure, Exercise, Pharmaceutical industry

CAMPBELL, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced pipeline updates and program milestones.

Key Points: 
  • CAMPBELL, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced pipeline updates and program milestones.
  • “VIVUS has been continuously dedicated to addressing the therapeutic needs of patients with serious medical conditions and life-limiting diseases, including exocrine pancreatic insufficiency, obesity and pulmonary arterial hypertension,” said John Amos, Chief Executive Officer at VIVUS LLC.
  • QSYMIA® is now the number one branded oral product in the US for obesity treatment.
  • Moreover, VIVUS is actively developing pipeline products focusing on bone marrow transplant preparation (VI-0609) and diabetes treatments (VI-0809 and VI-0810).”

Insmed Provides Business Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Friday, January 5, 2024
Pillar, Conference, Food, Agency, MAC, PAH, FDA, ASPEN, Polyp (medicine), Growth, Committee, Patient, Orthostatic hypertension, Mycobacterium avium complex, Pulmonary hypertension, Sinusitis, Pharmaceutical industry

BRIDGEWATER, N.J., Jan. 5, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today provided an update on the Company's four pillars and outlook for 2024. These updates will be discussed as part of the Company's presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 8, 2024, at 3:00 p.m. PT (6:00 p.m. ET).

Key Points: 
  • Insmed received encouraging written feedback from the U.S. Food and Drug Administration (FDA) on the patient-reported outcome data produced in the Phase 3 ARISE study in December 2023.
  • Presentation at the 42nd Annual J.P. Morgan Healthcare Conference
    Will Lewis, Chair and Chief Executive Officer of Insmed, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024, at 3:00 p.m. PT (6:00 p.m.
  • A live audio webcast of the presentation will be available on the Investor Relations section of the Company's website at www.insmed.com .
  • A replay will also be archived for a period of 30 days following the conclusion of the live event.

Liquidia Provides Update on Clinical Pipeline Targeting PAH and PH-ILD

Retrieved on: 
Friday, January 5, 2024
Food, PAH, FDA, PDUFA, Type, Pulmonary hypertension, Safety, Patient, Orthostatic hypertension, Pharmaceutical industry

The ASCENT study will enroll approximately 60 subjects to further inform YUTREPIA’s dosing and tolerability profile in patients with PH-ILD.

Key Points: 
  • The ASCENT study will enroll approximately 60 subjects to further inform YUTREPIA’s dosing and tolerability profile in patients with PH-ILD.
  • The FDA has previously confirmed that Liquidia may add the treatment of PH-ILD to the label for YUTREPIA without additional clinical studies.
  • It was agreed that only a single Phase 3 placebo-controlled efficacy trial in PH-ILD patients would be required to support indications to treat both PAH and PH-ILD.
  • Liquidia will also continue to enroll patients in its ongoing open-label, multicenter safety study of L606 in U.S. patients with PAH or PH-ILD.

Liquidia Corporation Announces $100 Million in New Financings

Retrieved on: 
Thursday, January 4, 2024
Sale, PAH, Investment, Patient, Orthostatic hypertension, Pulmonary hypertension, Security (finance)

The private placement is expected to close January 8, 2024, and yield gross proceeds of approximately $75.0 million.

Key Points: 
  • The private placement is expected to close January 8, 2024, and yield gross proceeds of approximately $75.0 million.
  • On January 3, 2024, HCRx and Liquidia entered a fourth amendment to the Revenue Interest Financing Agreement (RIFA) to fund an additional $25.0 million.
  • HCRx has now invested $67.5 million in non-dilutive capital from the $100 million originally contemplated from four tranches under the RIFA.
  • The remaining third tranche of $10.0 million and fourth tranche of $22.5 million can be funded in the future upon the mutual agreement of both HCRx and Liquidia.

Sagard Healthcare Announces Closing of Credit Facility and Recent Investment Highlights

Retrieved on: 
Thursday, January 4, 2024
Biotechnology, Commercial Building & Real Estate, Construction & Property, FDA, Professional Services, Health, Pharmaceutical, Medical Devices, Health Insurance, Asset Management, Finance, US FDA, Professional corporation, Health care, United Therapeutics, Partner, Helicobacter pylori, MannKind Corporation, Therapy, Pulmonary hypertension, Esophagitis, Growth, Investment, Dostarlimab, Orthostatic hypertension

Sagard Healthcare – a biopharmaceutical royalty and credit investor – today announced several developments and milestones for the strategy, including the closing of a $250 million permanent credit facility and the completion of nearly $250 million of new investments.

Key Points: 
  • Sagard Healthcare – a biopharmaceutical royalty and credit investor – today announced several developments and milestones for the strategy, including the closing of a $250 million permanent credit facility and the completion of nearly $250 million of new investments.
  • Sagard Healthcare invests in approved and medically-necessary biopharmaceuticals, medical devices, and diagnostics through royalty monetization, revenue interest financing and secured credit investments.
  • Sagard is pleased to announce that in December 2023, it closed a $250 million revolving credit facility with a syndicate of lenders.
  • The facility is expected to grow in size as Sagard continues to expand its portfolio of royalty and credit investments.

Human medicines European public assessment report (EPAR): Opsumit, macitentan, Date of authorisation: 20/12/2013, Revision: 23, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Blood pressure, Patient, Medical Subject Headings, Marketing, Artery, INN, Risk, Death, Woman, PAH, ATC, WHO, International, Population, Fatigue, Disease, Common, Nose, Headache, Blood, Language, Connective tissue, Periodic breathing, Inflammation, Pregnancy, Ventricular septal defect, European Medicines Agency, Tablet, Art, Select, Birth, Orthostatic hypertension, Anatomy, Anemia, IIA, Pressure, Medical device

Human medicines European public assessment report (EPAR): Opsumit, macitentan, Date of authorisation: 20/12/2013, Revision: 23, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Opsumit, macitentan, Date of authorisation: 20/12/2013, Revision: 23, Status: Authorised

MannKind and Sagard Healthcare Enter Into Royalty Purchase Agreement for Up to $200 Million

Retrieved on: 
Tuesday, January 2, 2024
Professional corporation, U.S. FDA, Morgan Stanley, FDA, MannKind Corporation, Internet, Therapy, Sidley Austin, Orthostatic hypertension, Cooley LLP, Pulmonary hypertension

Pursuant to a license agreement with United Therapeutics, MannKind is entitled to a 10% royalty on net sales of Tyvaso DPI, subject to certain reductions.

Key Points: 
  • Pursuant to a license agreement with United Therapeutics, MannKind is entitled to a 10% royalty on net sales of Tyvaso DPI, subject to certain reductions.
  • Under the terms of the royalty purchase agreement, Sagard Healthcare will receive royalty payments equal to 1% of the net sales of Tyvaso DPI that occur between October 1, 2023 and December 31, 2042, with MannKind retaining a 9% royalty.
  • Additional information regarding the royalty purchase agreement is provided in a Current Report on Form 8-K filed by MannKind with the U.S. Securities and Exchange Commission.
  • MannKind will host a conference call and presentation webcast to discuss this transaction January 3, 2024 at 9:00 a.m. Eastern Time.

U.S. Federal Circuit Affirms Earlier PTAB Decision to Invalidate All Claims of United Therapeutics Patent No. 10,716,793 (‘793 Patent)

Retrieved on: 
Wednesday, December 20, 2023
Drug, Food, UTHR, PAH, FDA, PDUFA, Inter partes review, Patent, NDA, IPR, United Therapeutics, Patient, Orthostatic hypertension, PTAB, Pulmonary hypertension, District court

10,716,793 (‘793 Patent) to be unpatentable due to the existence of prior art cited by Liquidia in inter partes review (IPR) proceedings.

Key Points: 
  • 10,716,793 (‘793 Patent) to be unpatentable due to the existence of prior art cited by Liquidia in inter partes review (IPR) proceedings.
  • Roger Jeffs, Chief Executive Officer of Liquidia, stated: “We are thrilled with the court’s swift decision.
  • We now have rulings from the Federal Circuit confirming that YUTREPIA does not infringe any valid claim in any of the three patents that were initially asserted by United Therapeutics.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024, for the PH-ILD indication.