Connective tissue disease

Inhibikase Therapeutics Announces Pre-IND Meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension

Retrieved on: 
Wednesday, April 3, 2024
Ventricular septal defect, DCN, Disease, HIV, Patient, CTD, Connective tissue disease, Death, Parkinson's disease, Imatinib, IND, Pulmonary hypertension, Woman, Therapy, Heart, Safety, Division, WHO, HIV/AIDS, Stomach, PAH, FDA, Blood, Food, Pharmaceutical industry

The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.

Key Points: 
  • The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.
  • “Following our pre-NDA discussion with the FDA related to the path to approval for IkT-001Pro in up to 11 blood and stomach cancers in January, we requested an additional FDA meeting with the Division of Cardiology and Nephrology to discuss Pro as a treatment for Pulmonary Arterial Hypertension,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase.
  • “PAH is a rare condition that primarily afflicts women between the ages of 30 and 60 and can lead to premature heart failure and death.
  • We believe that Pro may be a be a safer and better tolerated therapeutic option for imatinib treatment in PAH.

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."

Early Pulmonary Fibrosis Detection Holds the Key to Better Health Outcomes for Canadians Living with COVID-19 and Rheumatoid Arthritis

Retrieved on: 
Wednesday, February 28, 2024
Rare disease, Oxygen, Connective tissue disease, Research, Scleroderma, Physician, St. Joseph's Health Centre, Lupus, Crackle, Myositis, Pulmonary fibrosis, Life, CPFF, COVID-19, Signs, Rheumatoid arthritis, COVID, Patient, Disease, Diagnosis, Connective tissue, Interview, Face, Pharmaceutical industry

Canadians who have had COVID-19, and other chronic diseases, are experiencing Pulmonary Fibrosis (PF) at significantly higher rates than others, seemingly providing a causal link that researchers are investigating.

Key Points: 
  • Research is shedding light on the growing rate of pulmonary fibrosis (PF) being found in people suffering from long-term COVID-19.
  • One study, Post COVID-19 pulmonary fibrosis; a meta-analysis study , found that almost 45% (44.9%) of study participants began suffering from PF after contracting COVID-19.
  • Canadians suffering from long COVID are encouraged to watch for the early signs of pulmonary fibrosis, a disease that is growing in this population.
  • Dr. Janet Pope's webinar includes explanations for both physicians and thousands of people living with connective tissue diseases of what pulmonary fibrosis symptoms to watch for.

Werfen Receives US FDA 510(K) Clearance for Aptiva® Connective Tissue Disease Essential Reagent

Retrieved on: 
Monday, October 16, 2023
Autoimmune disease, Werfen, Doctor of Philosophy, PMAT, Health, Business, CTD, Connective tissue disease, Medical imaging, Fine chemical, IBM Aptiva, Research, Diagnosis

SAN DIEGO, Oct. 16, 2023 /PRNewswire/ -- Werfen today announced 510(k) clearance of Aptiva® Connective Tissue Disease (CTD) Essential reagent by the US Food and Drug Administration (FDA).

Key Points: 
  • New Reagent Aids in Diagnosis of Connective Tissue Disease in Hard-to-Diagnose Autoimmune Diseases, Reducing Time to Diagnosis and Improving Patient Outcomes
    The Aptiva CTD Essential complements Werfen's previously cleared Aptiva Celiac Disease reagent.
  • In addition to CTD and Celiac Disease assays, Aptiva will target additional autoimmune disease states, and has over 60 analytes in various stages of advanced development.
  • "We are excited to bring this latest expansion of the Aptiva reagent menu to the US market, resulting in advanced patient care."
  • PMAT enables Aptiva CTD Essential reagent to deliver up to 600 results per hour and allows the laboratory to complete its test volume with minimal hands-on time.

Can-Fite Submits Market Registration Plan to European Medicines Agency for Piclidenoson in the Treatment of Psoriasis; FDA Submission to Follow

Retrieved on: 
Tuesday, January 10, 2023
Managed Care, Biotechnology, Pharmaceutical, Health, Connective tissue disease, European Medicines Agency, CMC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Institute of Liver and Biliary Sciences, FDA, Psoriasis, NYSE, Food, CSO, Patient, Cancer, Clinical trial, Chemistry, CANF, Phase, EMA, TASE, Pharmaceutical industry, Apremilast

A submission to the U.S. Food and Drug Administration (FDA) will follow.

Key Points: 
  • A submission to the U.S. Food and Drug Administration (FDA) will follow.
  • Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s successful COMFORT™ Phase III study and the protocol for the Company’s upcoming Phase III pivotal trial together with a request for registration advice from the regulators.
  • Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are also included.
  • “This submission represents an important step toward the pivotal Phase III study and subsequent marketing approval of Piclidenoson,” said Dr. Pnina Fishman, CEO & CSO of Can-Fite BioPharma.

Preclinical Data from Aptinyx’s NMDA Receptor Modulators to be Presented at the 52nd Annual Meeting of the Society for Neuroscience

Retrieved on: 
Thursday, November 10, 2022
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Private Securities Litigation Reform Act, NMDA, Government budget balance, RATS, U.S. Securities and Exchange Commission, Opioid use disorder, APTX, Fear, Connective tissue disease, Annual report, NASDAQ, Brain, CA, Inc., NMDAR, Security (finance), Post-traumatic stress disorder, Central nervous system, Society, Trial of the century, Pharmaceutical industry

The presentations include preclinical data supporting the development of NYX-783, an NMDA receptor positive allosteric modulator in post-traumatic stress disorder and opioid use disorder.

Key Points: 
  • The presentations include preclinical data supporting the development of NYX-783, an NMDA receptor positive allosteric modulator in post-traumatic stress disorder and opioid use disorder.
  • Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.
  • Aptinyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Aptinyx Reports Third Quarter 2022 Financial Results and Recent Highlights

Retrieved on: 
Tuesday, November 8, 2022
Mental Health, Health, Neurology, General Health, Clinical Trials, Pharmaceutical, Biotechnology, PTSD, Investor, Fibromyalgia, Private Securities Litigation Reform Act, Initiative, National, NMDA, Government budget balance, HEAL, U.S. Securities and Exchange Commission, OUD, Research and development, Yale School of Medicine, Opioid use disorder, Webcast, Research, Annual report, NIH, Clinician, Oxycodone, R, Connective tissue disease, Chronic pain, Addiction, Brain, National Institute on Drug Abuse, Safety, ID, DSM-5, National Institute, Pharmacokinetics, Form 10-K, Patient, Security (finance), Administration, Post-traumatic stress disorder, Central nervous system, Yale University, NIDA, COVID-19, Trial of the century, Medical imaging, Pharmaceutical industry, Risk management

The study will be administered by the Yale Interdisciplinary Stress Center through a research collaboration with Aptinyx.

Key Points: 
  • The study will be administered by the Yale Interdisciplinary Stress Center through a research collaboration with Aptinyx.
  • In August 2022, Aptinyx announced that the primary endpoint was not achieved in its Phase 2b study of NYX-2925 in patients with fibromyalgia.
  • Net Loss: Net loss was $15.3 million for the third quarter of 2022, compared to a net loss of $21.2 million for the third quarter of 2021.
  • ET to review its financial results and highlights for the third quarter of 2022 and subsequent period.

The American Society for Clinical Pathology Expands List of Commonly Used Tests Physicians and Patients Should Question in Collaboration with ASCLS and ASM

Retrieved on: 
Tuesday, November 8, 2022
Plasma, Viral hepatitis, Human, Physician, Publication, Industry, Immunoglobulin G, Society, Patient, CMA Code of Ethics and Professionalism, Consumer, Professional, DLM, Decision-making, ASCP, Glycated hemoglobin, ENA, Certification, Disease, Connective tissue disease, EBV, Marie Cassidy, Neutropenia, Autoimmune hepatitis, INR, Student, Policy, Education, Urine, Partnership, Chlamydia trachomatis, American Society for Clinical Laboratory Science, ANA, Pathology, Neisseria gonorrhoeae, Medicine, DOAC, Choosing Wisely, ASM, Coeliac disease, Knowledge, MPH, AIH, Pharmaceutical industry, Medical imaging, Vaccine, Ethics, MD, Chlamydia

The lists of targeted, evidence-based recommendations are designed to support conversations between patients and physicians about what care is really necessary.

Key Points: 
  • The lists of targeted, evidence-based recommendations are designed to support conversations between patients and physicians about what care is really necessary.
  • The new Choosing Wisely recommendations, developed by ASCP in collaboration with ASCLS, include:
    1.Don't repeat HbA1c testing within 3 months of a previous result.
  • 2.Don't perform an extensive work-up in otherwise healthy neutropenic patients of African or Middle Eastern ancestry prior to Duffy-null phenotype testing.
  • The American Society for Microbiology (ASM) is the largest single life science society, composed of 30,000 scientists and health professionals.

Clinical Evaluation of Aptinyx's NYX-783 for Treatment of Opioid Use Disorder to Be Funded by $5.6 Million NIH Grant

Retrieved on: 
Thursday, November 3, 2022
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Blood pressure, Yale School of Medicine, Central nervous system, Annual report, Initiative, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NIDA, Private Securities Litigation Reform Act, Research, Foundation, Food, NMDA, Form 10-K, Yale University, Human, Inc., HEAL, Connective tissue disease, Safety, Respiratory rate, Brain, Heart rate, APTX, Addictive behavior, National, Trial of the century, Nasdaq, Opioid, Post-traumatic stress disorder, Methadone, National Institute, Opioid use disorder, Buprenorphine, U.S. Securities and Exchange Commission, Oxycodone, Fast Track, Government budget balance, National Institute on Drug Abuse, Addiction, Rainforest Foundation Fund, OUD, Psychiatry, NIH, Drug, PTSD, Fentanyl, Patient, Naltrexone, Pharmacokinetics, Program, Pharmaceutical industry

NYX-783 is an NMDA receptor positive allosteric modulator also in Phase 2b development by Aptinyx for the treatment of post-traumatic stress disorder (PTSD).

Key Points: 
  • NYX-783 is an NMDA receptor positive allosteric modulator also in Phase 2b development by Aptinyx for the treatment of post-traumatic stress disorder (PTSD).
  • Additional preclinical research has demonstrated NYX-783s potential as a treatment option for the millions of people struggling with opioid use disorder.
  • We are pleased to continue our collaboration with Aptinyx for the evaluation of NYX-783 for the treatment of OUD, said Dr. DiLeone.
  • The company has multiple product candidates in clinical development in central nervous system indications, including cognitive impairment, post-traumatic stress disorder, and opioid use disorder.

Aptinyx to Report Third Quarter 2022 Financial Results on Tuesday, November 8, 2022

Retrieved on: 
Tuesday, October 18, 2022
Biotechnology, Pharmaceutical, Health, Neurology, Lists of diseases, Connective tissue disease, Brain, Government budget balance, Webcast, Investor, ID, Central nervous system, APTX, Nasdaq, NMDA, Inc., Pharmaceutical industry

ET to report third quarter 2022 financial results and discuss recent business highlights.

Key Points: 
  • ET to report third quarter 2022 financial results and discuss recent business highlights.
  • To access the live conference call, please dial 844-200-6205 (domestic) or 929-526-1599 (international) and refer to conference ID 141144.
  • A live audio webcast of the event will be available on the Investors & Media section of Aptinyxs website at https://ir.aptinyx.com .
  • The company has two product candidates in clinical development in central nervous system indications, including cognitive impairment and post-traumatic stress disorder.