Andexanet alfa

Lexeo Therapeutics Strengthens Clinical Development Leadership with New Executive Appointments

Retrieved on: 
Monday, February 5, 2024
ACT, Cardiomyopathy, Duchenne muscular dystrophy, Pfizer, LMNA, MD, FDA, Andexanet alfa, Georgetown University Law Center, Mount Sinai School, ATTR, Senior advisor, International Society, Private practice, UCSD, Alexion, Law, Rare disease, Georgetown Journal, Nephrology, Neurology, Civil Service (United Kingdom), Biogen, University, Development, American Heart Association, Hospital, Orthostatic hypertension, Bachelor, Reata Pharmaceuticals, International law, Professor, Disclosure, Information technology, EMA, Southern Illinois University, Therapy, Assistant, Pediatrics, Sickle cell disease, Pharmaceutical industry

“The accumulating talent bench at Lexeo has overseen some of the most transformative clinical development programs, drug approvals and product launches in rare disease and precision cardiovascular medicine,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics.

Key Points: 
  • “The accumulating talent bench at Lexeo has overseen some of the most transformative clinical development programs, drug approvals and product launches in rare disease and precision cardiovascular medicine,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics.
  • During her tenure, Dr. See Tai led the late-stage clinical development program of tafamidis for ATTR cardiomyopathy (ATTR-ACT), which achieved global regulatory approvals, and the Phase 3 LMNA dilated cardiomyopathy clinical program.
  • In addition to late-stage clinical development, Dr. See Tai was responsible for strategic clinical planning for early-stage development candidates such as those for other genetic cardiomyopathies and Duchenne Muscular Dystrophy.
  • Dr. Adler’s work has led to the development of a novel cardiovascular gene therapy candidate entering late-stage clinical development.

Cellphire Therapeutics Appoints Pamela B. Conley to its Board of Directors

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Tuesday, February 8, 2022
Board of directors, Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Senior, BARDA, Dawn of X, United States Department of Health and Human Services, Department, NDAS, Multimedia, Science, Assistant, Blas, Board, Therapy, Inflammation, IND, Human services, Moses Austin, Berkeley, Bachelor of Arts in Organizational Psychology, Hyperlipidemia, University, CDER, Publication, Alexion, Coagulation, Cardiovascular disease, EMA, Contract research organization, Biotechnology, Research, CBER, Portola Pharmaceuticals, Lymphatic system, Regenerative medicine, Thrombosis, Development, Degenerative disease, Biochemistry, Atherosclerosis, Hemostasis, Pharmaceutical industry, Andexanet alfa

ROCKVILLE, Md., Feb. 8, 2022 /PRNewswire/ -- Cellphire Therapeutics, Inc., a biotechnology company developing next-generation allogeneic cellular therapeutics for application across multiple medical indications, announced today the appointment of Pamela B. Conley, Ph.D. to the company's Board of Directors.

Key Points: 
  • ROCKVILLE, Md., Feb. 8, 2022 /PRNewswire/ -- Cellphire Therapeutics, Inc., a biotechnology company developing next-generation allogeneic cellular therapeutics for application across multiple medical indications, announced today the appointment of Pamela B. Conley, Ph.D. to the company's Board of Directors.
  • I've been collaborating with Pam over the last year and look forward to her contributions as we build out our cellular therapeutics platform.
  • Dr. Conley is experienced in small molecule drug discovery and development as well as biologic drug development and manufacturing.
  • Cellphire Therapeutics, Inc. is a biotechnology company developing next-generation allogeneic cellular therapeutics.

Portola Pharmaceuticals Announces Results Demonstrating Andexxa® was Associated with Lowest Rate of Mortality in Patients with Multiple Types of Factor Xa Inhibitor-Related Bleeds

Retrieved on: 
Monday, March 16, 2020
Andexanet alfa, Antidotes

The data demonstrated that Andexxa was associated with a lower rate of in-hospital and 30-day mortality in patients with life-threatening Factor Xa inhibitor-related bleeds compared with other treatment options.

Key Points: 
  • The data demonstrated that Andexxa was associated with a lower rate of in-hospital and 30-day mortality in patients with life-threatening Factor Xa inhibitor-related bleeds compared with other treatment options.
  • "For the first time, we are presenting real-world data that demonstrates that for these patients Andexxa was associated with the lowest in-hospital mortality across a variety of other treatment options."
  • Among the subgroup of patients who experienced ICH, 30-day mortality was lower in the Andexxa group (15.3% vs. 48.9%), and the relative risk reduction was greater (68.7%).
  • Among the subset of patients who experienced ICH, the in-hospital mortality was 9% with Andexxa versus 25% with 4F-PCC.

New Data Demonstrates Andexxa® Can Provide a Net Cost Reduction for the Treatment of Intracranial Hemorrhage Associated with Oral Factor Xa Inhibitors

Retrieved on: 
Thursday, March 5, 2020
Anticoagulants, Coagulation system, Medicine, Andexanet alfa, Antidotes, Direct Xa inhibitor, Factor X, Branches of biology, Betrixaban, Coagulation, Portola Pharmaceuticals

Key findings from this analysis related to the net cost reduction Andexxa can provide for the treatment of ICH associated with oral Factor Xa inhibitors include:

Key Points: 
  • Key findings from this analysis related to the net cost reduction Andexxa can provide for the treatment of ICH associated with oral Factor Xa inhibitors include:
    The total cost per hospitalization, considering new technology add-on payment (NTAP) reimbursement for eligible claims, was $49,291 for patients treated with Andexxa and $54,699 for patients treated with 4F-PCC demonstrating a cost reduction of $5,408 with the use of Andexxa.
  • As a result, the analysis projected a potential total annual cost reduction of $259,608 for a hospital treating 48 of these patients per year with Andexxa in place of 4F-PCC.
  • The projected net cost reduction related to the use of Andexxa over three years totaled $392,652, assuming a proportional share of 4F-PCC use (based initially on current utilization in clinical practice).
  • The Company's first two commercialized products are Andexxa[coagulation factor Xa (recombinant), inactivated-zhzo], marketed inEuropeas Ondexxya(andexanet alfa), and Bevyxxa(betrixaban).

Andexxa Highlighted as a First-Line Factor Xa Reversal Option by the American College of Emergency Physicians

Retrieved on: 
Friday, November 15, 2019
Anticoagulants, Chemical compounds, Medicine, Organic compounds, Coagulation system, Lactams, RTT, Chloroarenes, Andexanet alfa, Rivaroxaban, Factor X, Direct Xa inhibitor

In the guidance statement, ACEP highlighted Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] as a first-in-line, U.S. Food and Drug Administration (FDA) approved reversal agent for patients treated with apixaban or rivaroxaban, as compared to 4F-PCC, which are highlighted as a second-in-line option for Factor Xa reversal and recommended for use only if Andexxa is not available.

Key Points: 
  • In the guidance statement, ACEP highlighted Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] as a first-in-line, U.S. Food and Drug Administration (FDA) approved reversal agent for patients treated with apixaban or rivaroxaban, as compared to 4F-PCC, which are highlighted as a second-in-line option for Factor Xa reversal and recommended for use only if Andexxa is not available.
  • "This new guidance aligns with clinical practice at our institution, where we are seeing positive clinical outcomes in patients treated with Andexxa."
  • Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo]is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
  • No thromboembolic events were observed in 223 healthy volunteers who received Factor Xa inhibitors and were treated with Andexxa.

Portola Pharmaceuticals to Present Multiple Abstracts at the 61st American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Wednesday, November 6, 2019
Medicine, Clinical medicine, Health, Cerdulatinib, Anticoagulant, Drug discovery, Andexanet alfa, Orphan drug, Portola Pharmaceuticals

"We are pleased to present data on two Portola medicines cerdulatinib and Andexxa at the ASH Annual Meeting," said Jeff Myers, M.D., Portola's interim chief medical officer.

Key Points: 
  • "We are pleased to present data on two Portola medicines cerdulatinib and Andexxa at the ASH Annual Meeting," said Jeff Myers, M.D., Portola's interim chief medical officer.
  • The U.S. Food and Drug Administration granted cerdulatinib Orphan Drug Designation for the treatment of PTCL in September 2018.
  • Treatment with Andexxa has been associated with serious and lifethreatening adverse events, including:
    Monitor for thromboembolic events and initiate anticoagulation when medically appropriate.
  • Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients.

Global Anticoagulant Reversal Drugs Market Report 2019: Rise of AF in Aging Populations, Increase in the Prevalence of ICH and GI Hemorrhages, NTAP Status for Specific Drugs

Retrieved on: 
Tuesday, November 5, 2019
Medicine, Clinical medicine, Antidotes, Branches of biology, Blood tests, Anticoagulant, Idarucizumab, Andexanet alfa, Thrombin, Vitamin K, Market

The global anticoagulant reversal drugs market report comprises an elaborate executive summary, which includes a snapshot that provides information about various segments of the market.

Key Points: 
  • The global anticoagulant reversal drugs market report comprises an elaborate executive summary, which includes a snapshot that provides information about various segments of the market.
  • It also provides information and data analysis of the global market with respect to the segments based on product, distribution channel, and region.
  • This section of the report also provides market attractiveness analysis by region, thereby presenting a thorough analysis of the overall competitive scenario in the global anticoagulant reversal drugs market.
  • Global Anticoagulant Reversal Drugs Market: Key Segments
    In terms of product, the global anticoagulant reversal drugs market has been segmented into prothrombin complex concentrates, vitamin K, protamine, tranexamic acid, idarucizumab, AndeXXa, and others.

Global Anticoagulant Reversal Drugs Market to 2026: Market Breakdown by Prothrombin Complex Concentrates, Vitamin K, Protamine, Tranexamic Acid, Idarucizumab, Andexxa, and Others - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 5, 2019
Health, Pharmaceutical, Medicine, Clinical medicine, Antidotes, Branches of biology, Blood tests, Anticoagulant, Idarucizumab, Andexanet alfa, Thrombin, Vitamin K

The "Anticoagulant Reversal Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018-2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Anticoagulant Reversal Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018-2026" report has been added to ResearchAndMarkets.com's offering.
  • The global anticoagulant reversal drugs market report comprises an elaborate executive summary, which includes a snapshot that provides information about various segments of the market.
  • This section of the report also provides market attractiveness analysis by region, thereby presenting a thorough analysis of the overall competitive scenario in the global anticoagulant reversal drugs market.
  • Global Anticoagulant Reversal Drugs Market: Key Segments
    In terms of product, the global anticoagulant reversal drugs market has been segmented into prothrombin complex concentrates, vitamin K, protamine, tranexamic acid, idarucizumab, AndeXXa, and others.

Portola Pharmaceuticals Presents New Analysis from the ANNEXA-4 Study of its Factor Xa Inhibitor Reversal Agent Andexxa® in Patients with Acute Gastrointestinal Bleeding

Retrieved on: 
Monday, October 28, 2019
Coagulation system, Medicine, Clinical medicine, Anticoagulants, Body fluids, Direct Xa inhibitor, Factor X, Andexanet alfa, Coagulation, Portola Pharmaceuticals

Among the 352 patients in the ANNEXA-4 study, 90 (26%) were treated for acute GI bleedingand 62 (18%) were evaluable for hemostatic efficacy.

Key Points: 
  • Among the 352 patients in the ANNEXA-4 study, 90 (26%) were treated for acute GI bleedingand 62 (18%) were evaluable for hemostatic efficacy.
  • Both the exploratory analysis and full study results showed that Andexxa rapidly and potently reversed anti-factor Xa activity.
  • All of the thrombotic events occurred in patients who delayed or did not re-start anticoagulation therapy with a Factor Xa inhibitor during the follow-up period.
  • Andexxa is a recombinant protein specifically designed to bind to Factor Xa inhibitors and rapidly reverse their anticoagulant effect.

Portola Launches European Sales of Ondexxya® (Andexanet Alfa) with First Orders in Europe

Retrieved on: 
Tuesday, August 6, 2019
Portola Pharmaceuticals, Pharmaceuticals policy, Antidotes, Health, Andexanet alfa, Portola, Marketing authorization

SOUTH SAN FRANCISCO, Calif., Aug. 6, 2019 /PRNewswire/ --Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) today announced the Company's first sales of Ondexxya (andexanet alfa) in Europe.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Aug. 6, 2019 /PRNewswire/ --Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) today announced the Company's first sales of Ondexxya (andexanet alfa) in Europe.
  • "We look forward to continuing discussions with individual reimbursement authorities and further expanding access to Ondexxya in Europe."
  • Ondexxya is now recognized in nine European medical society guidelines, including the European Stroke Organisation.
  • The European Commission (EC) granted conditional Marketing Authorization for Ondexxya in Europe in April 2019.