Orthostatic hypertension

Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution

Retrieved on: 
Tuesday, March 12, 2024
Online, Endo International, Brain, Exercise, Blood, Patient, Knowledge, Travel, Stroke, Hospital, Par, Prostacyclin, Death, Particulates, NDC, Orthostatic hypertension, Completeness, Heart, Water, Administration, FDA, Swelling, Food

The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Key Points: 
  • The product is being recalled due to the potential for the presence of silicone particulates in the product solution.
  • Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material.
  • Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01.
  • If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

Edison issues initiation on Cereno Scientific (CRNO B): Differentiated approach in CVD with potential

Retrieved on: 
Wednesday, March 13, 2024
Thomas Edison, HDAC, CVD, Risk, GMT, PAH, Thrombosis, Bleeding, Phase, Orthostatic hypertension, Probability, Valproate, Publication, Editorial, Partnership, Pharmaceutical industry

Cereno Scientific is a clinical-stage biotech, developing treatments for cardiovascular diseases (CVDs) using novel approaches.

Key Points: 
  • Cereno Scientific is a clinical-stage biotech, developing treatments for cardiovascular diseases (CVDs) using novel approaches.
  • Lead asset CS1, a delayed immediate release formulation of valproic acid, is an HDAC inhibitor, aiming to deliver disease-modifying results in pulmonary arterial hypertension (PAH).
  • Preclinical candidates include CS014, for thrombosis prevention without increased risk of bleeding (seen with current antithrombotics), and CS585 for CVD (specific indication not yet determined).
  • As with all Edison publications, Edison controls the editorial and timings of publications and we wish to make it clear that Cereno Scientific had no involvement in the aforementioned issue.

Keros Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024
Therapy, Research, Syndrome, Investment, Obesity, Technology transfer, Growth, KROS, PAH, Patient, Disorder, Protein, Ruxolitinib, Cytopenia, Orthostatic hypertension, Haematopoiesis, Keros, Pharmaceutical industry

Keros did not generate any revenue for the year ended December 31, 2022.

Key Points: 
  • Keros did not generate any revenue for the year ended December 31, 2022.
  • Research and development expenses were $37.5 million for the fourth quarter and $135.3 million for the year ended December 31, 2023, as compared to $24.9 million for the fourth quarter and $87.3 million for the year ended December 31, 2022.
  • General and administrative expenses were $9.1 million for the fourth quarter and $34.8 million for the year ended December 31, 2023, as compared to $7.1 million and $27.5 million for the fourth quarter and year ended December 31, 2022.
  • Keros’ cash and cash equivalents as of December 31, 2023 was $331.1 million compared to $279.0 million as of December 31, 2022.

Gossamer Bio Announces Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, Pharmaceutical, Health, Cardiology, GOSS, Research, New Drug Application, Research and development, Marketing, Security (finance), Functional, Pulmonary hypertension, Entrepreneurship, PAH, PMDA, Administration, Gossamer, Patient, Public expenditure, Clinical trial, Medication, Orthostatic hypertension, G&A, Pharmaceutical industry

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 its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update.

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 its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update.
  • “This advancement marks a significant milestone in Gossamer’s journey, and it was made possible due to the tireless efforts of the Gossamer team.
  • Topline results from the PROSERA Study are expected in the fourth quarter of 2025.
  • Financial Results for Quarter and Full Year Ended December 31, 2023
    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2023, were $296.4 million.

Quince Therapeutics Appoints Former Reata Pharmaceuticals Chief R&D Officer Dr. Rajiv Patni to its Board of Directors

Retrieved on: 
Thursday, February 15, 2024
Biotechnology, Health, Science, Pharmaceutical, Research, Therapy, Acquisition, Pfizer, Roche, Cardiology, Food, Neurology, Reata Pharmaceuticals, Portola Pharmaceuticals, European Medicines Agency, Sickle cell disease, Disease, Actelion, Orthostatic hypertension, AIDE, Biology, Development, Biogen, Pharmaceutical industry

“We are pleased to welcome a proven clinical development leader of Dr. Rajiv Patni’s caliber to our Board of Directors,” said David Lamond, chairperson of Quince’s Board of Directors.

Key Points: 
  • “We are pleased to welcome a proven clinical development leader of Dr. Rajiv Patni’s caliber to our Board of Directors,” said David Lamond, chairperson of Quince’s Board of Directors.
  • Most recently, he served as Chief Research and Development Officer at Reata Pharmaceuticals, a commercial-stage company recently acquired by Biogen.
  • Previously, Dr. Patni also served as Chief Medical Officer at several successful public, small-cap, and commercial-stage biopharmaceutical companies – Global Blood Therapeutics, Portola Pharmaceuticals, and Adamas Pharmaceuticals.
  • Earlier in his career, Dr. Patni held roles of increasing responsibility at Pfizer, Roche, and Actelion.

FDA Approves First Medication to Treat Severe Frostbite

Retrieved on: 
Wednesday, February 14, 2024
Human services, Group 1, Blood pressure, Division, Research, Aspirin, Headache, The, Frostbite, Cosmetics, Multimedia, Group 3, Flushing, Blood, Physician, FDA, Dietary supplement, Food, Dizziness, Skin, Nausea, Finger, Cardiology, Vomiting, Standard of care, Vaccine, Risk, Animal, Iloprost, Amputation, Safety, Heated tobacco product, Group 2, Nephrology, Public, Patient, Palpitations, Orthostatic hypertension, Hypotension, Priority review

SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

Key Points: 
  • SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.
  • Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation.
  • Iloprost's efficacy in treating severe frostbite was primarily established in an open-label, controlled trial that randomized 47 adults with severe frostbite, who all received aspirin by vein and standard of care, into one of three treatment groups.
  • The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3).

First PFAS "Forever Chemicals" Consumer-Initiated Blood Test with Physician Consult Launches on questhealth.com

Retrieved on: 
Monday, February 12, 2024
Water supply, Physician, Orthostatic hypertension, B2B, Poison, Doctor of Pharmacy, Agency, Vaccine, Risk, Health, National academy, Firefighter, History, Quest Diagnostics, Organization, PFAS, Pre-eclampsia, Patient, Toxicology, Kidney, Science, CDC, DGX, Birth weight, Environment, Cosmetics

"Our PFAS blood test is based on the latest science and aligns with several facets of new CDC guidance as well as recommendations from the National Academies of Sciences, Engineering, and Medicine.

Key Points: 
  • "Our PFAS blood test is based on the latest science and aligns with several facets of new CDC guidance as well as recommendations from the National Academies of Sciences, Engineering, and Medicine.
  • Not everyone needs a PFAS test, but people at high risk of elevated exposure may benefit from greater access to the insights provided by this novel test."
  • It is the first PFAS blood test available as a consumer-initiated test with physician consult to report a sum of PFAS chemicals based on level of health risks identified by the National Academies of Sciences, Engineering, and Medicine (NASEM).
  • The Quest test aligns with several recommendations from NASEM on PFAS testing, including:
    Quantifying levels of several specific PFAS chemicals identified for potential health risks.

Closed Loop Medicine Demonstrates Application of Novel Drug Plus Software Product for Personalized Treatment of Hypertension

Retrieved on: 
Thursday, February 8, 2024
Medical Devices, Health, Health Technology, Clinical Trials, Pharmaceutical, Biotechnology, COVID-19, Innovation, American College, Senior, Orthostatic hypertension, Medicine, Invention, Death, Amlodipine, Therapy, Disease, Drug intolerance, Patient, Cerebral edema, COVID, Triage, Trust, Hypertension, BP, Journal, American Heart Association, Journal of Human Hypertension, JAHA, Innovate UK, Blood pressure, Pharmaceutical industry

Closed Loop Medicine Ltd., a leading TechBio company developing combination prescription drug plus software therapy products that deliver personalized dose optimization, today announced the publication of a peer-reviewed study in the Journal of the American Heart Association (JAHA) (1).

Key Points: 
  • Closed Loop Medicine Ltd., a leading TechBio company developing combination prescription drug plus software therapy products that deliver personalized dose optimization, today announced the publication of a peer-reviewed study in the Journal of the American Heart Association (JAHA) (1).
  • Hypertension is the leading preventable cause of morbidity and premature death worldwide.
  • High adherence rates were reported (both app usage and medication) and patient retention was exceptionally high with no discontinuations due to drug intolerance.
  • Dr. Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine, commented: “These findings are invaluable in demonstrating the power of personalizing the dose of existing therapeutics in areas as widely impactful as hypertension.

Lexeo Therapeutics Strengthens Clinical Development Leadership with New Executive Appointments

Retrieved on: 
Monday, February 5, 2024
ACT, Cardiomyopathy, Duchenne muscular dystrophy, Pfizer, LMNA, MD, FDA, Andexanet alfa, Georgetown University Law Center, Mount Sinai School, ATTR, Senior advisor, International Society, Private practice, UCSD, Alexion, Law, Rare disease, Georgetown Journal, Nephrology, Neurology, Civil Service (United Kingdom), Biogen, University, Development, American Heart Association, Hospital, Orthostatic hypertension, Bachelor, Reata Pharmaceuticals, International law, Professor, Disclosure, Information technology, EMA, Southern Illinois University, Therapy, Assistant, Pediatrics, Sickle cell disease, Pharmaceutical industry

“The accumulating talent bench at Lexeo has overseen some of the most transformative clinical development programs, drug approvals and product launches in rare disease and precision cardiovascular medicine,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics.

Key Points: 
  • “The accumulating talent bench at Lexeo has overseen some of the most transformative clinical development programs, drug approvals and product launches in rare disease and precision cardiovascular medicine,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics.
  • During her tenure, Dr. See Tai led the late-stage clinical development program of tafamidis for ATTR cardiomyopathy (ATTR-ACT), which achieved global regulatory approvals, and the Phase 3 LMNA dilated cardiomyopathy clinical program.
  • In addition to late-stage clinical development, Dr. See Tai was responsible for strategic clinical planning for early-stage development candidates such as those for other genetic cardiomyopathies and Duchenne Muscular Dystrophy.
  • Dr. Adler’s work has led to the development of a novel cardiovascular gene therapy candidate entering late-stage clinical development.

Liquidia Corporation Announces Poster Presentation at the Pulmonary Vascular Research Institute 2024 Annual Congress

Retrieved on: 
Tuesday, January 30, 2024
Orthostatic hypertension, Patient, Pulmonary Vascular Research Institute, Pulmonary hypertension, PAH

MORRISVILLE, N.C., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today announced that the Company will present data from the L606 clinical program at the Pulmonary Vascular Research Institute (PVRI) 2024 Annual Congress to be held January 31 through February 3, 2024, in London, England.

Key Points: 
  • MORRISVILLE, N.C., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today announced that the Company will present data from the L606 clinical program at the Pulmonary Vascular Research Institute (PVRI) 2024 Annual Congress to be held January 31 through February 3, 2024, in London, England.
  • L606 is an investigational, sustained-release formulation of treprostinil administered twice-daily to treat patients diagnosed with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • Thematic Poster Session: Novel therapeutic targets or approaches, clinical trials, diagnostic tests, and care delivery