IVH

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

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

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

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.

NovelMed Phase I Clinical Trial Shows Inhibition of the Alternative Pathway and Preservation of the Classical Pathway – A Long-Acting Anti-Properdin Monoclonal Antibody NM3086 for PNH Patients

Retrieved on: 
Monday, June 5, 2023

Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.

Key Points: 
  • Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.
  • Correspondingly, the classical pathway (CP) remained unaffected, suggesting that NM3086 selectively blocks the AP while maintaining the host defense.
  • The duration of AP-C3b inhibition followed the AP inhibition profile very closely in a dose dependent manner.
  • CLEVELAND, June 05, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics, Inc. announced today topline results from First-in-Human Phase I clinical trial of its complement blocker monoclonal anti-Properdin antibody, known as NM3086.

Delaware Investments® Dividend and Income Fund, Inc., Delaware Enhanced Global Dividend and Income Fund, and Delaware Ivy High Income Opportunities Fund Announce Date of Reorganizations

Retrieved on: 
Thursday, December 22, 2022

Today, the Board of Directors/Trustees of Delaware Investments Dividend and Income Fund (NYSE: “DDF”), Delaware Enhanced Global Dividend and Income Fund (NYSE: “DEX”), and Delaware Ivy High Income Opportunities Fund (NYSE: “IVH”) announced that the anticipated closing date of the reorganization of DDF and DEX into abrdn Global Dynamic Dividend Fund (NYSE: “AGD”) and the reorganization of IVH into abrdn Income Credit Strategies Fund (NYSE: “ACP”) (together, the “Reorganizations”), will each be completed by the open of business on the New York Stock Exchange on Monday, March 13, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • Today, the Board of Directors/Trustees of Delaware Investments Dividend and Income Fund (NYSE: “DDF”), Delaware Enhanced Global Dividend and Income Fund (NYSE: “DEX”), and Delaware Ivy High Income Opportunities Fund (NYSE: “IVH”) announced that the anticipated closing date of the reorganization of DDF and DEX into abrdn Global Dynamic Dividend Fund (NYSE: “AGD”) and the reorganization of IVH into abrdn Income Credit Strategies Fund (NYSE: “ACP”) (together, the “Reorganizations”), will each be completed by the open of business on the New York Stock Exchange on Monday, March 13, 2023, subject to the satisfaction of customary closing conditions.
  • To facilitate the Reorganizations, all shares of DDF, DEX, and IVH will cease trading on the New York Stock Exchange as of market close on Friday, March 10, 2023.
  • The Reorganizations, if completed, would each occur based on the relative net asset values of the common shares of DDF, DEX, and IVH (together, the “Funds”).
  • Further details on any applicable special distribution will be made available in a future press release.

IRRAS Announces Participation and Data Presentation at the 22nd European Congress of Neurosurgery

Retrieved on: 
Thursday, October 13, 2022

The 22nd European Congress of Neurosurgery will take place in Belgrade, Serbia, on October 16-20, 2022.

Key Points: 
  • The 22nd European Congress of Neurosurgery will take place in Belgrade, Serbia, on October 16-20, 2022.
  • Dr. Rezai Jahromi will also lead a live IRRAflow educational session on Tuesday, October 18th, at 1000 CET within the IRRAS booth in the Congress' Exhibit Hall.
  • STOCKHOLM, Oct. 13, 2022 /PRNewswire/ --IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced it will be exhibiting at EANS 2022, the 22nd European Congress of Neurosurgery, hosted by the European Association of Neurological Societies.
  • Attendees of EANS 2022 are encouraged to learn more about IRRAS' products, including its IRRAflow Active Fluid Exchange system, by visiting IRRAS' booth #10.

IRRAS Announces Participation and Data Presentation at the 22nd European Congress of Neurosurgery

Retrieved on: 
Thursday, October 13, 2022

The 22nd European Congress of Neurosurgery will take place in Belgrade, Serbia, on October 16-20, 2022.

Key Points: 
  • The 22nd European Congress of Neurosurgery will take place in Belgrade, Serbia, on October 16-20, 2022.
  • Dr. Rezai Jahromi will also lead a live IRRAflow educational session on Tuesday, October 18th, at 1000 CET within the IRRAS booth in the Congress' Exhibit Hall.
  • STOCKHOLM, Oct. 13, 2022 /PRNewswire/ --IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced it will be exhibiting at EANS 2022, the 22nd European Congress of Neurosurgery, hosted by the European Association of Neurological Societies.
  • Attendees of EANS 2022 are encouraged to learn more about IRRAS' products, including its IRRAflow Active Fluid Exchange system, by visiting IRRAS' booth #10.

Delaware Ivy High Income Opportunities Fund Appoints Adam H. Brown and John P. McCarthy as Co-Managers

Retrieved on: 
Tuesday, September 14, 2021

Today, Delaware Ivy High Income Opportunities Fund (NYSE: IVH) (the Fund), a New York Stock Exchangelisted closed-end fund trading under the symbol IVH, announced that, effective Nov. 14, 2021, Adam H. Brown and John P. McCarthy will be appointed as co-managers for the Fund.

Key Points: 
  • Today, Delaware Ivy High Income Opportunities Fund (NYSE: IVH) (the Fund), a New York Stock Exchangelisted closed-end fund trading under the symbol IVH, announced that, effective Nov. 14, 2021, Adam H. Brown and John P. McCarthy will be appointed as co-managers for the Fund.
  • Adam H. Brown, CFA, Managing Director, is a senior portfolio manager for the firms high yield strategies within Macquarie Investment Management Fixed Income (MFI).
  • He manages MFIs bank loan portfolios and is a co-portfolio manager for the high yield, fixed rate multisector, and core plus strategies.
  • John P. McCarthy, CFA, Managing Director, is a senior portfolio manager for the Macquarie Investment Management Fixed Income (MFI) high yield strategies, a role he assumed in July 2016.