Veloxis Pharmaceutic (LFCYF) 0.1460 $LFCYF
Envarsus® XR Demonstrates Improved Pharmacokinetic Profile in African-American Transplant Recipients
PR Newswire - Mon May 04, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose of once-daily Envarsus XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus. These data, which are from one of the largest trials of tacrolimus pharmacokinetics (PK) in African-American kidney transplant patients conducted to date, were presented at the American Transplant Congress (ATC) on May 3, 2015, in Philadelphia, in a presentation entitled "PK and Pharmacogenomics of Once-daily MeltDose® Tacrolimus (Envarsus® XR) vs. Twice-daily Tacrolimus: A Randomized Cross-over Study in Stable African-American Kidney Transplant Patients (ASERTAA)". There are several additional presentations on Envarsus XR at ATC, which are listed below.
U.S. District Court Sets Briefing Schedule in Veloxis Litigation
PR Newswire - Wed Jan 14, 1:32PM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that the U.S. District Court for the District of Columbia has set a briefing schedule that enables complete briefing in its pending case by March 3, 2015. Veloxis is seeking an order requiring FDA to grant final approval to Envarsus® XR. While Veloxis currently expects the matter to be resolved by mid-year 2015, it is possible that delays may occur. There can be no assurance that Veloxis will be successful in its action against FDA.
Veloxis Confirms Receipt of U.S. Food and Drug Administration Decision
PR Newswire - Tue Jan 13, 2:05AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that it has received notice from the U.S. Food and Drug Administration (FDA) stating that FDA continues to take the position that the exclusivity for Astagraf XL should require delay in the formal approval of Envarsus® XR. FDA has stated that it would be prepared to approve Envarsus XR for use only in patients converted from an immediate release formulation of tacrolimus to Envarsus XR, subject to Veloxis not seeking approval for de novo use of Envarsus until on or after July 19, 2016. Veloxis continues to disagree with FDA's unprecedented position on this matter, and looks forward to presenting the merits of its case in support of final approval of Envarsus XR.
Veloxis Comments on U.S. District Court Order
PR Newswire - Fri Dec 19, 8:41AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today issued the following statement regarding an order issued by the U.S. District Court for the District of Columbia in connection with the action Veloxis filed on December 16, 2014 against the Food and Drug Administration (FDA), seeking an order requiring the FDA to grant final approval to Envarsus® XR:
Veloxis announces that it has filed an action against the Food and Drug Administration, seeking an order requiring FDA to grant final approval to Envarsus® XR
PR Newswire - Tue Dec 16, 4:38PM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) announced today that it has filed an action in federal district court for the District of Columbia against the Food and Drug Administration, seeking an order requiring FDA to grant final approval to Envarsus® XR.
Veloxis Announces Publication of Phase III Study of Once Daily Envarsus® XR Demonstrating Non-Inferiority vs. Twice-Daily Tacrolimus in De Novo Kidney Transplant Patients
PR Newswire - Mon Nov 17, 7:53AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of the Phase III study (Study 3002) of once-daily Envarsus® XR demonstrating non-inferiority vs. twice-daily tacrolimus (Prograf®) in de novo kidney transplant patients in the American Journal of Transplantation.
Veloxis announces tentative approval of Envarsus® XR
PR Newswire - Fri Oct 31, 6:16AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) announced today that the U.S. Food and Drug Administration has informed Veloxis of the tentative approval of Envarsus® XR. FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL®. Veloxis understands that this expiry is anticipated to occur July 19, 2016. FDA's approval notice stated that it is "subject to change on the basis of any new information that may come to FDA's attention."
Kidney Transplantation Therapeutic Pipeline Review, H2 2014 - 29 Drug Profiles From 18 Companies
M2 - Tue Sep 09, 6:41AM CDT
Research and Markets (http://www.researchandmarkets.com/research/2mqfkc/kidney) has announced the addition of the "Kidney Transplantation - Pipeline Review, H2 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Kidney Transplantation, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Kidney Transplantation and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Kyowa Hakko Kirin Co., Ltd. - GlaxoSmithKline plc - Quark Pharmaceuticals, Inc. - Pharming Group N.V. - Grifols, S.A. - Novartis AG - Astellas Pharma Inc. - Shire Plc - Veloxis Pharmaceuticals A/S - La Jolla Pharmaceutical Company - Hansa Medical AB - Digna Biotech, S.L. - Viron Therapeutics, Inc. - Opsona Therapeutics Ltd. - Angion Biomedica Corp. - NovImmune SA - Tolera Therapeutics, Inc. - Bio-inRen Drug Profiles - tacrolimus ER - voclosporin - eculizumab - ASKP-1240 - belimumab - foralumab - cardiotrophin-1 - C1 esterase inhibitor (human) - BB-3 - QPI-1002 - TOL-101 - OPN-305 - IgG-Degrading Enzyme of Streptococcus pyogenes - FCR-001 - Immucellgram - C1 esterase inhibitor (human) - CFZ-533 - VT-111a - VT-214 - C1 esterase inhibitor (recombinant) - LJPC-101 - AS-2521780 - FFP-106 - ETR-002 - Cell Therapy for Kidney Transplantation - T-Cell Therapy for Kidney Transplant - Monoclonal Antibody to Inhibit CD47 for Kidney Transplantation and Ischemia Reperfusion Injury - BRN-1889 - albumin (human) For more information visit http://www.researchandmarkets.com/research/2mqfkc/kidney
SHPG: 254.45 (+3.99), GSK: 44.77 (-0.22), NVS: 103.75 (-0.15)
Envarsus® Receives European Marketing Authorization for Treatment of Both Kidney and Liver Transplant Patients
PR Newswire - Mon Jul 28, 1:30AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
Envarsus® XR Demonstrates Lower Treatment Failure Rate in African-Americans Compared to Twice-Daily Tacrolimus (Prograf®)
PR Newswire - Mon Jun 30, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®). These study data will be presented at the World Transplant Congress (WTC), July 26 to 31, in San Francisco, in a presentation entitled "Lower Treatment Failures in Blacks and Older De Novo and Stable Kidney Transplant Recipients Treated with Envarsus XR Once-Daily MeltDose Tablets vs. Twice Daily Prograf Capsules." The presentation will occur at 6:30 pm - 8:00 PM, Sunday, July 27th, 2014. There are several additional presentations on Envarsus XR at WTC in addition to the subgroup analysis on African-American patients, which are summarized below.
Veloxis Announces Positive Two-Year Results from Pivotal Phase 3 Study of Envarsus® XR (tacrolimus extended-release tablets) in de novo Kidney Transplant Patients
PR Newswire - Mon Jun 23, 10:50AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR (tacrolimus extended-release tablets) in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma). Data will be presented in a late-breaker session at the World Transplant Congress (WTC) in San Francisco, entitled "Two-Year Results of Envarsus (Once-daily MeltDose Tacrolimus Tablets) vs Prograf (Twice-daily Tacrolimus Capsules): A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study" at 6:30 p.m. PDT on July 27th.
Envarsus® XR Demonstrates Improved Pharmacokinetic Profile in African-American Transplant Recipients
PR Newswire - Mon May 04, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose of once-daily Envarsus XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus. These data, which are from one of the largest trials of tacrolimus pharmacokinetics (PK) in African-American kidney transplant patients conducted to date, were presented at the American Transplant Congress (ATC) on May 3, 2015, in Philadelphia, in a presentation entitled "PK and Pharmacogenomics of Once-daily MeltDose® Tacrolimus (Envarsus® XR) vs. Twice-daily Tacrolimus: A Randomized Cross-over Study in Stable African-American Kidney Transplant Patients (ASERTAA)". There are several additional presentations on Envarsus XR at ATC, which are listed below.
U.S. District Court Sets Briefing Schedule in Veloxis Litigation
PR Newswire - Wed Jan 14, 1:32PM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that the U.S. District Court for the District of Columbia has set a briefing schedule that enables complete briefing in its pending case by March 3, 2015. Veloxis is seeking an order requiring FDA to grant final approval to Envarsus® XR. While Veloxis currently expects the matter to be resolved by mid-year 2015, it is possible that delays may occur. There can be no assurance that Veloxis will be successful in its action against FDA.
Veloxis Confirms Receipt of U.S. Food and Drug Administration Decision
PR Newswire - Tue Jan 13, 2:05AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that it has received notice from the U.S. Food and Drug Administration (FDA) stating that FDA continues to take the position that the exclusivity for Astagraf XL should require delay in the formal approval of Envarsus® XR. FDA has stated that it would be prepared to approve Envarsus XR for use only in patients converted from an immediate release formulation of tacrolimus to Envarsus XR, subject to Veloxis not seeking approval for de novo use of Envarsus until on or after July 19, 2016. Veloxis continues to disagree with FDA's unprecedented position on this matter, and looks forward to presenting the merits of its case in support of final approval of Envarsus XR.
Veloxis Comments on U.S. District Court Order
PR Newswire - Fri Dec 19, 8:41AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today issued the following statement regarding an order issued by the U.S. District Court for the District of Columbia in connection with the action Veloxis filed on December 16, 2014 against the Food and Drug Administration (FDA), seeking an order requiring the FDA to grant final approval to Envarsus® XR:
Veloxis announces that it has filed an action against the Food and Drug Administration, seeking an order requiring FDA to grant final approval to Envarsus® XR
PR Newswire - Tue Dec 16, 4:38PM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) announced today that it has filed an action in federal district court for the District of Columbia against the Food and Drug Administration, seeking an order requiring FDA to grant final approval to Envarsus® XR.
Veloxis Announces Publication of Phase III Study of Once Daily Envarsus® XR Demonstrating Non-Inferiority vs. Twice-Daily Tacrolimus in De Novo Kidney Transplant Patients
PR Newswire - Mon Nov 17, 7:53AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of the Phase III study (Study 3002) of once-daily Envarsus® XR demonstrating non-inferiority vs. twice-daily tacrolimus (Prograf®) in de novo kidney transplant patients in the American Journal of Transplantation.
Veloxis announces tentative approval of Envarsus® XR
PR Newswire - Fri Oct 31, 6:16AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) announced today that the U.S. Food and Drug Administration has informed Veloxis of the tentative approval of Envarsus® XR. FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL®. Veloxis understands that this expiry is anticipated to occur July 19, 2016. FDA's approval notice stated that it is "subject to change on the basis of any new information that may come to FDA's attention."
Kidney Transplantation Therapeutic Pipeline Review, H2 2014 - 29 Drug Profiles From 18 Companies
M2 - Tue Sep 09, 6:41AM CDT
Research and Markets (http://www.researchandmarkets.com/research/2mqfkc/kidney) has announced the addition of the "Kidney Transplantation - Pipeline Review, H2 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Kidney Transplantation, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Kidney Transplantation and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Kyowa Hakko Kirin Co., Ltd. - GlaxoSmithKline plc - Quark Pharmaceuticals, Inc. - Pharming Group N.V. - Grifols, S.A. - Novartis AG - Astellas Pharma Inc. - Shire Plc - Veloxis Pharmaceuticals A/S - La Jolla Pharmaceutical Company - Hansa Medical AB - Digna Biotech, S.L. - Viron Therapeutics, Inc. - Opsona Therapeutics Ltd. - Angion Biomedica Corp. - NovImmune SA - Tolera Therapeutics, Inc. - Bio-inRen Drug Profiles - tacrolimus ER - voclosporin - eculizumab - ASKP-1240 - belimumab - foralumab - cardiotrophin-1 - C1 esterase inhibitor (human) - BB-3 - QPI-1002 - TOL-101 - OPN-305 - IgG-Degrading Enzyme of Streptococcus pyogenes - FCR-001 - Immucellgram - C1 esterase inhibitor (human) - CFZ-533 - VT-111a - VT-214 - C1 esterase inhibitor (recombinant) - LJPC-101 - AS-2521780 - FFP-106 - ETR-002 - Cell Therapy for Kidney Transplantation - T-Cell Therapy for Kidney Transplant - Monoclonal Antibody to Inhibit CD47 for Kidney Transplantation and Ischemia Reperfusion Injury - BRN-1889 - albumin (human) For more information visit http://www.researchandmarkets.com/research/2mqfkc/kidney
SHPG: 254.45 (+3.99), GSK: 44.77 (-0.22), NVS: 103.75 (-0.15)
Envarsus® Receives European Marketing Authorization for Treatment of Both Kidney and Liver Transplant Patients
PR Newswire - Mon Jul 28, 1:30AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
Envarsus® XR Demonstrates Lower Treatment Failure Rate in African-Americans Compared to Twice-Daily Tacrolimus (Prograf®)
PR Newswire - Mon Jun 30, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®). These study data will be presented at the World Transplant Congress (WTC), July 26 to 31, in San Francisco, in a presentation entitled "Lower Treatment Failures in Blacks and Older De Novo and Stable Kidney Transplant Recipients Treated with Envarsus XR Once-Daily MeltDose Tablets vs. Twice Daily Prograf Capsules." The presentation will occur at 6:30 pm - 8:00 PM, Sunday, July 27th, 2014. There are several additional presentations on Envarsus XR at WTC in addition to the subgroup analysis on African-American patients, which are summarized below.
Veloxis Announces Positive Two-Year Results from Pivotal Phase 3 Study of Envarsus® XR (tacrolimus extended-release tablets) in de novo Kidney Transplant Patients
PR Newswire - Mon Jun 23, 10:50AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR (tacrolimus extended-release tablets) in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma). Data will be presented in a late-breaker session at the World Transplant Congress (WTC) in San Francisco, entitled "Two-Year Results of Envarsus (Once-daily MeltDose Tacrolimus Tablets) vs Prograf (Twice-daily Tacrolimus Capsules): A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study" at 6:30 p.m. PDT on July 27th.
