Angiotensin

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

Retrieved on: 
Monday, April 8, 2024

These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.

Key Points: 
  • These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.
  • The beneficial effects of a high intensity statin and EPA on endothelial dysfunction may contribute to reduced atherothrombotic risk in outcome trials.
  • Elevated Lp(a) levels are an independent and causal risk factor for cardiovascular (CV) disease with limited treatments available.
  • The potent antioxidant actions of EPA may contribute to reduced CV events in REDUCE-IT, including among those subjects with elevated Lp(a).

Alnylam to Webcast Investor Event to Discuss Results from KARDIA-2 Phase 2 Study of Zilebesiran at American College of Cardiology Scientific Session

Retrieved on: 
Wednesday, March 20, 2024

The event will include presentations and a Q&A session with Alnylam management and Akshay Desai, M.D., Director of the Cardiomyopathy and Heart Failure Program, Brigham and Women’s Hospital.

Key Points: 
  • The event will include presentations and a Q&A session with Alnylam management and Akshay Desai, M.D., Director of the Cardiomyopathy and Heart Failure Program, Brigham and Women’s Hospital.
  • A replay of the call will be available two hours after the call and archived on the same webpage for six months.
  • A live audio webcast of the call will be available on the Investors section of the Company’s website at www.alnylam.com/events .
  • An archived webcast will be available on the Company’s website approximately two hours after the event.

Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

Retrieved on: 
Monday, March 11, 2024

The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

Key Points: 
  • The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
  • “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
  • “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
  • The FDA has 60 days from the receipt of the application to determine whether to accept it for review.

Alnylam Reports Positive KARDIA-2 Topline Study Results Demonstrating Clinically Significant Blood Pressure Reductions When Zilebesiran is Added to Standard of Care Antihypertensives

Retrieved on: 
Tuesday, March 5, 2024

Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives.

Key Points: 
  • Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives.
  • “We are thrilled that a single dose of zilebesiran achieved clinically significant, additional reductions in systolic blood pressure when administered to patients who are not adequately controlled with commonly prescribed antihypertensives,” said Simon Fox, Ph.D., Vice President, Zilebesiran Program Lead at Alnylam.
  • “These KARDIA-2 results, showing durable additional levels of blood pressure reduction on top of what is achieved by standard of care first-line antihypertensives with an encouraging safety profile, reinforce our confidence in zilebesiran’s differentiated profile.
  • The primary endpoint is the change from baseline in mean SBP at Month 3, assessed by 24-hour ABPM.

Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 19, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 19, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 19, Status: Authorised

Alnylam Announces Publication of Phase 1 Study Results for Zilebesiran in the New England Journal of Medicine

Retrieved on: 
Wednesday, July 19, 2023

Zilebesiran also demonstrated an acceptable safety profile supporting continued clinical development; the most frequent treatment-related adverse events were mild, transient injection-site reactions.

Key Points: 
  • Zilebesiran also demonstrated an acceptable safety profile supporting continued clinical development; the most frequent treatment-related adverse events were mild, transient injection-site reactions.
  • The most frequent treatment-related adverse events were mild, transient injection-site reactions reported in five (6 percent) patients who received zilebesiran.
  • In Parts B and E of the study, blood pressure changes following zilebesiran treatment could be attenuated through high dietary salt intake and were augmented by irbesartan coadministration.
  • *Five patients receiving placebo in Part A of the study re-enrolled into Part E of the study and thus transitioned from placebo to zilebesiran.

EQS-News: PAION AG publishes GROUP QUARTERLY STATEMENT for the first quarter of 2023

Retrieved on: 
Wednesday, May 17, 2023

Gregor Siebert, CEO of PAION AG, commented: "At the beginning of April 2023, we were able to reach an important milestone in the company's history.

Key Points: 
  • Gregor Siebert, CEO of PAION AG, commented: "At the beginning of April 2023, we were able to reach an important milestone in the company's history.
  • At the beginning of 2023, PAION again received positive feedback from customers about their experience with remimazolam in particular.
  • Research and development expenses in the first quarter of 2023 amounted to EUR 0.9 million (prior-year period: EUR 1.1 million).
  • PAION expects revenues from operating activities of approximately EUR 13 million to approximately EUR 19 million in 2023.

Brooke Army Medical Center (BAMC) Establishes Clinical Utility of Seraph 100 for Critically Ill Patients Suffering from Septic Shock Caused by Multiple Pathogens Including Candida

Retrieved on: 
Tuesday, May 2, 2023

Brooke Army Medical Center published positive results for critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter.

Key Points: 
  • Brooke Army Medical Center published positive results for critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter.
  • CDC has issued a recent warning considering the threat of Candida auris to public health, so emerging evidence of Seraph 100 successful treatment of Candida infections is timely.
  • The Seraph 100 is an extracorporeal blood filter used to remove pathogens from the bloodstream of patients who are critically ill from infections that cause septic shock, i.e., the reduced blood pressure that often leads to cascading illness and death.
  • ExThera Medical previously confirmed that Seraph 100 is effective at removing many different bacteria, viruses and fungi, including the often-deadly Candida auris strain.

ISHLT and ISHLT Foundation Fund Research and Career Development with Grants

Retrieved on: 
Saturday, April 22, 2023

The grants were funded by the ISHLT Foundation, and announced at the 43rd ISHLT Annual Meeting & Scientific Sessions, held 19-22 April in Denver.

Key Points: 
  • The grants were funded by the ISHLT Foundation, and announced at the 43rd ISHLT Annual Meeting & Scientific Sessions, held 19-22 April in Denver.
  • These grants are the first of two 2023 ISHLT grant cycles.
  • “I am truly grateful for the strong industry support of our ISHLT research grants,” said Kathleen Grady, PhD, RN, MS, FAAN, Chair of the ISHLT Grants and Awards Committee, “which contribute to scientific breakthroughs in the areas of advanced heart and lung disease across the lifespan and career development of new investigators.
  • For more information about ISHLT and ISHLT Foundation Research Grants, visit ishlt.org/research-data/grants-awards/research-grants .