EVH

Onco360 Has Been Selected as the Sole National Specialty Pharmacy Partner for Voydeya® (danicopan)

Retrieved on: 
Monday, April 8, 2024
Immune system, PNH, Specialty pharmacy, Patient, Ravulizumab, FDA, Eculizumab, Paroxysmal nocturnal hemoglobinuria, EVH, Blood, Alexion Pharmaceuticals

LOUISVILLE, Ky., April 08, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a national pharmacy partner by Alexion Pharmaceuticals for Voydeya® (Danicopan) as a first class oral, Factor D inhibitor.

Key Points: 
  • LOUISVILLE, Ky., April 08, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a national pharmacy partner by Alexion Pharmaceuticals for Voydeya® (Danicopan) as a first class oral, Factor D inhibitor.
  • It is FDA-approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in combination with C5 inhibitor, Ultomiris® (Ravulizumab) or Soliris® (Eculizumab) for patients that experience clinically significant extravascular hemolysis (EVH).1 Voydeya® is an oral, Factor D inhibitor that acts in the alternative complement pathway of the immune system, providing control of red blood cell destruction within and outside the blood vessels.
  • “Onco360 appreciates the opportunity to partner further with the team at Alexion and become the sole national specialty pharmacy provider for Voydeya®”, said Benito Fernandez, Chief Commercial Officer.
  • “We are proud to add this first in class oral Factor D inhibitor treatment option for PNH patients.”

VOYDEYA™ approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in adults with the rare disease PNH

Retrieved on: 
Monday, April 1, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Factor D, Arthralgia, Chest pain, Confusion, Neuropsychological test, Infection, Eculizumab, Risk, Headache, ALPHA, PNH, C5, Patient, Orphan, Mitigation, Vaccine, Light, Paroxysmal nocturnal hemoglobinuria, EVH, Bacteria, University, Chills, MD, Breakthrough therapy, Cough, European Medicines Agency, Fatigue, Nausea, Rash, Fever, Priority, Safety, Immune system, REMS, Division, Vomiting, Hematology, Patient safety, Medicine

VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.

Key Points: 
  • VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.
  • You must complete or update meningococcal vaccine(s) and streptococcus vaccine(s) at least 2 weeks before your first dose of VOYDEYA.
  • If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting VOYDEYA.
  • Carry it with you at all times during treatment and for 1 week after your last VOYDEYA dose.

Getinge takes a leap forward in cardiovascular surgery with the 510(k) clearance for Vasoview Hemopro 3

Retrieved on: 
Friday, March 8, 2024
EVH, FDA, Food, Smoke, Getinge, Safety, Patient, Medtech, Partnership, Medical device

Designed with customer centricity top of mind, the newcomer is expected to offer enhanced procedural efficiency in healthcare from the upcoming launch.

Key Points: 
  • Designed with customer centricity top of mind, the newcomer is expected to offer enhanced procedural efficiency in healthcare from the upcoming launch.
  • Receiving the FDA 510(k) clearance for Vasoview Hemopro 3 marks a significant milestone for Getinge and underscores the effort to comply with the highest safety and effectiveness standards, emphasizing the medtech company's commitment to advancing medtech.
  • The new generation of Vasoview – Hemopro 3 – symbolizes our dedication to elevating healthcare standards together with our customers," says Elin Frostehav, President Acute Care Therapies at Getinge.
  • The culmination of extensive market research and advisory boards conducted in partnership with clinicians within the EVH field, Vasoview Hemopro 3 represents collaborative innovation.

Evolent Adds Russell Glass, Headspace CEO, to Board of Directors

Retrieved on: 
Wednesday, February 14, 2024
EVH, Mental health, Intelligence, Marketing, Health, Growth, Glass, Sale, Ginger, Duke University, Economics, Management

Dr. Sotunde stated, "I've been incredibly impressed with Evolent during my time on the Board.

Key Points: 
  • Dr. Sotunde stated, "I've been incredibly impressed with Evolent during my time on the Board.
  • I would also like to take this opportunity to welcome Russ Glass to the Evolent Board of Directors.
  • Chair of the Evolent Board of Directors Cheryl Scott added, "On behalf of my fellow Directors, we want to thank Tunde for his commitment and valuable contributions to Evolent during the last several years."
  • Ms. Scott continued, "After conducting a broad, national search, the Board is pleased to appoint Russell Glass as an Evolent Director.

EVH® ANNOUNCES THE LAUNCH OF NEW SA-126 AVAILABLE IN MAY

Retrieved on: 
Friday, January 26, 2024
Quilt, Beauty, Social media, Neck, Mammoth WVH, Fender, Gear, Harmonica, Burn, EVH, HERE, Furniture

"The SA-126 was born out of necessity for finding my own sound," said Wolfgang Van Halen. "

Key Points: 
  • "The SA-126 was born out of necessity for finding my own sound," said Wolfgang Van Halen. "
  • I wanted to do my own thing and that's how I gravitated towards semi-hollow bodies and how it became my core sound.
  • It creates a new categorization for electric guitar and is characterized by its limitless nature.
  • Other features include a Harmonica bridge and stop bar tailpiece, oversized strap buttons, and keystone tuning pegs.

Evolent to Release Fourth Quarter 2023 Financial Results on Thursday, February 22, 2024

Retrieved on: 
Thursday, January 25, 2024
Health, Conference, Medtech, EVH

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Evolent Health, Inc. (NYSE: EVH), a company that specializes in better health outcomes for people with complex conditions through proven solutions that make health care simpler and more affordable, today announced it will release its fourth quarter 2023 financial results on Thursday, Feb. 22, 2024, after market close, with a conference call to follow at 5 p.m. ET.

Key Points: 
  • Shareholders and interested participants may listen to a live broadcast of the conference found on Evolent's investor relations website, https://ir.evolenthealth.com .
  • Analysts interested in asking questions during the live call should dial 855.940.9467, or 412.317.6034 for international callers, and reference the "Evolent call" 15 minutes prior to the call.
  • An audio playback of the conference call will be available on Evolent's investor relations website for 90 days after the call.
  • Cowen 44th Annual Health Care Conference at the Boston Marriott Copley Place in Boston, Massachusetts, on Monday, March 4, 2024.

Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

Retrieved on: 
Wednesday, December 6, 2023
Phase, Patient, EVH, Food, Immune system, Physician, FDA, Haematopoietic system, Anemia, Blood, PNH, RBC, City, MD, Novartis, Hematology, MRCP, IVH, Paroxysmal nocturnal hemoglobinuria, Pharmaceutical industry

Approval was also supported by the Phase III APPOINT-PNH study in complement inhibitor-naïve patients1,3.

Key Points: 
  • Approval was also supported by the Phase III APPOINT-PNH study in complement inhibitor-naïve patients1,3.
  • Patients with sustained hemoglobin level ≥ 12 g/dLa in the absence of transfusions: 67.7% of anti-C5-experienced Fabhalta patients responded vs. 0% for anti-C5 (difference of 66.6%b, P
  • Patients avoiding transfusiond,e: Transfusion avoidance rate 95.2% for anti-C5-experienced Fabhalta patients vs. 45.7% for anti-C5 (difference of 49.5%b, P
  • In APPOINT-PNH, serious ARs were reported in two (5%) patients with PNH receiving Fabhalta, which included COVID-19 and bacterial pneumonia1,3.

Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

Retrieved on: 
Wednesday, December 6, 2023
Paroxysmal nocturnal hemoglobinuria, Immune system, EVH, City, Haematopoietic system, IVH, PNH, Patient, FDA, MRCP, Hematology, Blood, Novartis, MD, Phase, Anemia, Physician, RBC, Pharmaceutical industry

Patients with sustained hemoglobin level ≥ 12 g/dLa in the absence of transfusions: 67.7% of anti-C5-experienced Fabhalta patients responded vs. 0% for anti-C5 (difference of 66.6%b, P

Key Points: 
  • Patients with sustained hemoglobin level ≥ 12 g/dLa in the absence of transfusions: 67.7% of anti-C5-experienced Fabhalta patients responded vs. 0% for anti-C5 (difference of 66.6%b, P
  • Patients avoiding transfusiond,e: Transfusion avoidance rate 95.2% for anti-C5-experienced Fabhalta patients vs. 45.7% for anti-C5 (difference of 49.5%b, P
  • In APPLY-PNH, serious ARs were reported in two (3%) patients with PNH receiving Fabhalta, which included pyelonephritis, urinary tract infection and COVID-191,2.
  • In APPOINT-PNH, serious ARs were reported in two (5%) patients with PNH receiving Fabhalta, which included COVID-19 and bacterial pneumonia1,3.

NovelMed Commences Phase II Trial for Anti-Bb Antibody (NM8074) in Treatment-Naïve PNH Patients: A Glimpse into the PNH Study Progress

Retrieved on: 
Monday, October 30, 2023
FDA, CP, PNH, Hemolysis, C3b, LDH, Intravascular hemolysis, Phase, Phase II, EVH, Lactate dehydrogenase, RBC, Risk, Paroxysmal nocturnal hemoglobinuria, AP, Safety, IVH, Therapy, Patient, Infection, PRBC, Pharmaceutical industry, Haptoglobin, Hemoglobin, Reticulocyte

Regulatory approval for the Phase II trial in treatment-naïve PNH patients was granted based on the safety and tolerance demonstrated in the previous Phase I clinical trial involving healthy subjects.

Key Points: 
  • Regulatory approval for the Phase II trial in treatment-naïve PNH patients was granted based on the safety and tolerance demonstrated in the previous Phase I clinical trial involving healthy subjects.
  • CLEVELAND, Oct. 30, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics is excited to announce the commencement of its Phase II clinical trial targeting treatment-naïve Paroxysmal Nocturnal Hemoglobinuria (PNH) patients with its groundbreaking anti-Bb antibody, NM8074.
  • This open-label, multi-dose, and multi-center study aims to assess the safety and efficacy of NM8074 in PNH patient population.
  • The Phase II study is divided into two cohorts, featuring a biweekly dosing schedule spanning a 3-month assessment period.

Evolent to release third quarter financial results on Thursday, Nov. 2, 2023, and participate in upcoming investor conferences

Retrieved on: 
Tuesday, October 10, 2023
NYSE, EVH, EvoL, The Westin New York Grand Central Hotel, Stephens, Health, Financial Services Forum, Canaccord Genuity, Blackley, Piper Sandler Companies, Westin St. Francis, Lotte New York Palace Hotel, Digital health, Conference, Pharmaceutical industry

Shareholders and interested participants may listen to a live broadcast of the conference found on Evolent's investor relations website, ir.evolenthealth.com.

Key Points: 
  • Shareholders and interested participants may listen to a live broadcast of the conference found on Evolent's investor relations website, ir.evolenthealth.com.
  • An audio playback of the conference call will be available on Evolent's investor relations website for 90 days after the call.
  • Additionally, the company announced that Chief Executive Officer Seth Blackley, Chief Financial Officer John Johnson and Vice President, Investor Relations Seth Frank will participate in upcoming investor conferences.
  • Messrs. Johnson and Frank will present virtually at the BTIG Digital Health Forum on Monday, Nov. 20, 2023.