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Cardiol Therapeutics Announces it has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis

Retrieved on: 
Tuesday, January 9, 2024

Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."

Key Points: 
  • Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."
  • The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence.
  • The trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in North America, France, Brazil, and Israel.
  • Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases.

Tenaya Therapeutics Announces FDA Clearance to Begin Clinical Testing of TN-401 Gene Therapy for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy

Retrieved on: 
Thursday, October 26, 2023

SOUTH SAN FRANCISCO, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of the company’s Investigational New Drug (IND) application to initiate clinical testing of TN-401.

Key Points: 
  • TN-401 is Tenaya’s adeno-associated virus serotype 9 (AAV9)-based investigational gene therapy product candidate for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the plakophilin-2 (PKP2) gene.
  • Tenaya is currently conducting the RIDGE™ global non-interventional natural history and serotype study of PKP2-associated ARVC.
  • ARVC, also known as arrhythmogenic cardiomyopathy (ACM), is a chronic, progressive, familial disease that typically presents before age 40.
  • People with ARVC experience symptoms related to ventricular arrhythmias, including palpitations, lightheadedness and fainting, and are at increased risk of sudden cardiac death.

Association of Black Cardiologists partners with the No Time to Wait campaign to host Kareem Abdul-Jabbar at the "Heart of the Matter" Town Hall

Retrieved on: 
Wednesday, September 13, 2023

WASHINGTON, Sept. 13, 2023 /PRNewswire/ -- The Association of Black Cardiologists (ABC), in collaboration with the Bristol Myers Squibb-Pfizer Alliance's No Time to Wait campaign, will host a virtual and in-person town hall meeting titled "Heart of the Matter," on September 15, 2023 at 6:30 p.m. ET. The event will feature basketball legend and award-winning writer Kareem Abdul-Jabbar who will discuss his personal experience living with atrial fibrillation (AFib), the most common type of irregular heartbeat.

Key Points: 
  • The event will feature basketball legend and award-winning writer Kareem Abdul-Jabbar who will discuss his personal experience living with atrial fibrillation (AFib), the most common type of irregular heartbeat.
  • These symptoms are often ignored because they may come and go and can vary among different individuals.
  • We are proud to facilitate this discussion and believe it will be a powerful tool in raising awareness about AFib."
  • To register for the Heart of the Matter Town Hall, visit https://bit.ly/SOHTownHallWithKAJ .

Acer Therapeutics Reacquires Worldwide Development, Commercialization and Economic Rights to OLPRUVA™ from Relief Therapeutics, Excluding the Geographical Europe

Retrieved on: 
Wednesday, August 30, 2023

OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).

Key Points: 
  • OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).
  • Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe.
  • Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™.
  • For additional Important Safety Information, see full Prescribing Information , Patient Package Insert and discuss with your doctor.

Antidepressants can cause withdrawal symptoms – here’s what you need to know

Retrieved on: 
Thursday, June 22, 2023

Millions of people worldwide take antidepressants to help with depression. But as a recent BBC Panorama found, many aren’t aware of the fact that antidepressants can cause withdrawal symptoms when you stop taking them. For some, these symptoms can be severe and long-lasting. Here’s what you should know.What causes antidepressant withdrawal?This process of adaption is often termed physical dependence, which leads to tolerance (lessening effects over time) and withdrawal when stopping.

Key Points: 


Millions of people worldwide take antidepressants to help with depression. But as a recent BBC Panorama found, many aren’t aware of the fact that antidepressants can cause withdrawal symptoms when you stop taking them. For some, these symptoms can be severe and long-lasting. Here’s what you should know.

What causes antidepressant withdrawal?

    • This process of adaption is often termed physical dependence, which leads to tolerance (lessening effects over time) and withdrawal when stopping.
    • After even just a few weeks of antidepressant use, our serotonin receptors become less sensitive, meaning that we probably need more serotonin to elicit the same effects.
    • This is what causes withdrawal symptoms.

What are the symptoms?

    • Emotional withdrawal symptoms include low mood, anxiety, panic attacks, irritability, anger, crying spells and feeling suicidal.
    • There are a few ways to distinguish withdrawal symptoms from relapse – the return of a past mental health condition.
    • Physical withdrawal symptoms will be distinct from the original condition, and sometimes the emotional symptoms are recognisably different from the symptoms you initially had.

How long do withdrawal symptoms last?

    • Many people (including practitioners) believe withdrawal symptoms only last as long as it takes the drug to leave your system – typically, days or weeks.
    • Clinical studies have also shown that antidepressant withdrawal symptoms can last for weeks, months and, in some people, years.

Does withdrawal only happen with long-term use?

    • One patient survey found only a small minority experienced withdrawal after taking the drug for a few months.
    • But more than half who’d taken antidepressants longer than three years experienced withdrawal – of which, half reported moderate or severe symptoms.

How should you stop antidepressants?

    • While some patients can tolerate this, we know that for many long-term antidepressant users, this approach produces intolerable withdrawal symptoms that can make it impossible to stop these drugs.
    • The last few milligrams of these drugs are the hardest to come off, so need to be reduced particularly carefully.
    • But it’s important people are made aware of the risk of withdrawal effects, so they can make an informed decision.

Bell Law Firm Secures $4M for Georgia Woman Following Medical Negligence

Retrieved on: 
Tuesday, May 30, 2023

Examinations that followed revealed pain to Ms. Perron’s distal lateral ankle with fibula, mild pain to the lateral ankle, ecchymosis, and edema.

Key Points: 
  • Examinations that followed revealed pain to Ms. Perron’s distal lateral ankle with fibula, mild pain to the lateral ankle, ecchymosis, and edema.
  • “This is why we trust juries,” stated Lloyd Bell, founding partner at Bell Law Firm.
  • We hope the jury’s decision provides Christine peace and closure as she moves forward.”
    Lloyd Bell has over 30 years of trial experience and has recovered hundreds of millions for medical negligence victims, including a record $75M medical malpractice verdict – the largest in Georgia history.
  • If you believe you have a medical malpractice case, contact Bell Law Firm today for a free consultation.

Hoag Bringing Leading-Edge Mitral Valve Replacement Option to Orange County and Selected for the MOMENTIS Study

Retrieved on: 
Monday, April 17, 2023

NEWPORT BEACH, Calif., April 17, 2023 /PRNewswire/ -- Hoag is recruiting patients for a long-term study designed to collect real-world clinical outcomes for a new mitral valve replacement option.

Key Points: 
  • NEWPORT BEACH, Calif., April 17, 2023 /PRNewswire/ -- Hoag is recruiting patients for a long-term study designed to collect real-world clinical outcomes for a new mitral valve replacement option.
  • Because the valve has already received FDA approval, Hoag has already performed more than a dozen mitral valve replacements using this valve over the last eight months.
  • To qualify for the study, patients are required to be otherwise healthy and in need of a mitral valve replacement, rather than a valve repair procedure.
  • "More than 90% of mitral valve surgeries at Hoag are performed to repair the mitral valve.

Today is Heart Valve Disease Awareness Day

Retrieved on: 
Wednesday, February 22, 2023

WASHINGTON, Feb. 22, 2023 /PRNewswire/ -- Today, more than 120 organizations, joined by countless advocates and individuals across the globe are raising awareness for Valve Disease Day by increasing recognition about the risks of heart valve disease and improving detection and treatment access to ultimately save lives. Valve Disease Day activities involve heart screenings with stethoscopes, story sharing, educational events, social media campaigns, and more.

Key Points: 
  • WASHINGTON, Feb. 22, 2023 /PRNewswire/ -- Today, more than 120 organizations, joined by countless advocates and individuals across the globe are raising awareness for Valve Disease Day by increasing recognition about the risks of heart valve disease and improving detection and treatment access to ultimately save lives.
  • Valve Disease Day activities involve heart screenings with stethoscopes, story sharing, educational events, social media campaigns, and more.
  • More than 84 million around the world have heart valve disease, and more than 25,000 deaths are attributed to valve disease in the U.S. each year.
  • The biggest risk factor for valve disease is age: 1 in 10 people 75 and older are estimated to have moderate or severe heart valve disease.

Trevena Announces Publication of OLINVYK Respiratory Physiology Study In ANESTHESIOLOGY

Retrieved on: 
Tuesday, February 14, 2023

CHESTERBROOK, Pa., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the publication of OLINVYK data in the peer-reviewed journal Anesthesiology. The paper, entitled “Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine” was published in collaboration with researchers at several prestigious institutions, including the Leiden University Medical Center in the Netherlands. A link to the paper can be found at https://www.trevena.com/publications.

Key Points: 
  • The paper summarizes the key findings of the four-arm, double-blind, randomized crossover study of eighteen 56- to 87-year-old male and female participants.
  • The intent of the study was to evaluate the difference between oliceridine and IV morphine as measured by the effect on ventilation.
  • The results of the study demonstrated that oliceridine and morphine differed in their pharmacodynamics with a more rapid onset and offset of respiratory depression for oliceridine and a smaller magnitude of respiratory depression over time.
  • These data may be relevant in the clinical care of elderly patients.”
    As with all opioids, serious, life-threatening, or fatal respiratory depression may occur in patients treated with OLINVYK as indicated in the boxed warning.

My Cardiologist Launches The Women's Heart Health Program

Retrieved on: 
Thursday, February 2, 2023

MIAMI, Feb. 2, 2023 /PRNewswire/ -- Novocardia, a value-based cardiovascular disease care platform, and My Cardiologist, a trusted provider of cardiovascular services in South Florida for more than 60 years, are pleased to announce the launch of The Women's Heart Health Program in South Florida. The new cardiac clinical center will focus on preventing, diagnosing and treating cardiovascular disease, 70% of which is preventable.

Key Points: 
  • Recognizing that women face unique risk factors for heart disease, the Women's Heart Health Program is designed to ensure that women receive expert specialty care for all their cardiovascular needs.
  • Yet heart disease in women is often overlooked and under-diagnosed," says Dr. Abbe Rosenbaum, a cardiologist and nuclear cardiologist at My Cardiologist who is leading the new women's heart program.
  • "The women's heart program will seek to reach women from diverse communities through partnerships and outreach with churches and other community groups."
  • The women's heart program will include prevention services and screenings, a personalized assessment of heart disease risk and care from specialists in interventional cardiology, structural cardiology, electrophysiology, heart failure and peripheral venous and arterial disease.