Tacrolimus

Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Retrieved on: 
Tuesday, March 5, 2024

Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.

Key Points: 
  • Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.
  • Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024.
  • We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.
  • Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.

Lipella Pharmaceuticals to Present at PropThink Digital Investor Conference

Retrieved on: 
Tuesday, February 20, 2024

the potential of therapies in late-stage development to replace existing, toxic standards of care.

Key Points: 
  • the potential of therapies in late-stage development to replace existing, toxic standards of care.
  • why hemorrhagic cystitis (HC) is a large, overlooked opportunity and where existing treatments stand.
  • Following the presentation, investors will have an opportunity to ask relevant questions through an interactive Q&A portal.
  • The webcast link will also be posted on the Investors section of Lipella’s company website , and archived following the event.

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024

Retrieved on: 
Saturday, February 10, 2024

EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when…, Agenda Agenda of the PRAC meeting 5-8 February 2024DraftFirst published: 05/02/2024Last updated: 06/02/2024Reference Number: EMA/PRAC/11237/2024…, PRAC statistics: February 2024, PRAC statistics: February 2024First published: 09/02/2024 English (EN) (22.52 MB - PDF)View , Glossary:Safety signal assessments.

Key Points: 
  • EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when…, Agenda Agenda of the PRAC meeting 5-8 February 2024DraftFirst published: 05/02/2024Last updated: 06/02/2024Reference Number: EMA/PRAC/11237/2024…, PRAC statistics: February 2024, PRAC statistics: February 2024First published: 09/02/2024 English (EN) (22.52 MB - PDF)View , Glossary:Safety signal assessments.
  • A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine…, Ongoing referralsProcedureStatusUpdateHydroxyprogesterone-containing medicinal products – Article-31 referralUnder evaluationPRAC continued its assessment

TFF Pharmaceuticals Announces Acceptance of Late-Breaking Abstract for Presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting

Retrieved on: 
Tuesday, January 9, 2024

FORT WORTH, Texas, Jan. 09, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the acceptance of a late-breaking abstract for presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024.

Key Points: 
  • FORT WORTH, Texas, Jan. 09, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the acceptance of a late-breaking abstract for presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024.
  • “Despite the availability of numerous immunosuppressive therapies, the unmet medical need remains high in lung transplantation, which has a 5-year mortality of approximately 50%.
  • New targeted therapeutic approaches are clearly needed that can optimize immunosuppression in the lung while avoiding the dose-limiting toxicities associated with systemically administered immunosuppressive therapies,” said Professor Gregory Snell, Medical Head of Lung Transplant Service at the Alfred Hospital and Lead Principal Investigator of the Phase 2 TFF TAC trial.
  • “Initial data from the ongoing Phase 2 study suggest that TFF TAC, which delivers tacrolimus directly to the lungs, may represent a viable approach in achieving this desired balance, and I look forward to presenting initial data from the Phase 2 trial at the upcoming ISHLT 2024 meeting.”

Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2024 Outlook

Retrieved on: 
Thursday, January 4, 2024

IRVINE, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced a summary of 2023 accomplishments and provided guidance for anticipated upcoming 2024 milestones.

Key Points: 
  • IRVINE, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced a summary of 2023 accomplishments and provided guidance for anticipated upcoming 2024 milestones.
  • Amended the Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
  • Dosed first participants in Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • 2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute.

Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished

Retrieved on: 
Wednesday, December 20, 2023

PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.

Key Points: 
  • PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.
  • Based in Pittsburgh, PA, the Company has made substantial strides over the past year, achieving critical milestones and advancing its pipeline with three clinical indications and two orphan drug designations granted.
  • Additionally, Lipella's LP-310 has been granted orphan drug designation for the treatment of oral graft-versus-host disease (GVHD) with tacrolimus.
  • The Company is poised to submit a Phase 2a IND for this indication in the first quarter of 2024.

PrecisePK Redefines Precision Dosing with Academic Integration, Setting New Standards In Therapeutic Drug Monitoring

Retrieved on: 
Wednesday, November 29, 2023

This acknowledgment fortifies PrecisePK's position as a trusted academic-centric platform revolutionizing precision drug dosing.

Key Points: 
  • This acknowledgment fortifies PrecisePK's position as a trusted academic-centric platform revolutionizing precision drug dosing.
  • This move solidifies PrecisePK's role in advancing therapeutic drug monitoring and precision medicine.
  • This strategic alliance is a pivotal step forward in advancing patient drug safety education and elevating clinical precision drug dosing standards across the region," says Anjum Gupta, CEO of PrecisePK.
  • PrecisePK stands at the forefront of revolutionizing precision dosing with its state-of-the-art Bayesian Model-Informed Precision Dosing (MIPD) software.

Aurinia Presents Breadth of Data from AURORA Clinical Program Underscoring Value of LUPKYNISⓇ (voclosporin) for Patients with Lupus Nephritis at ACR 2023

Retrieved on: 
Tuesday, November 7, 2023

Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.

Key Points: 
  • Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.
  • In AURORA 1, patients received LUPKYNIS® 23.7 mg BID in combination with MMF (target dose 2 g/day) and oral glucocorticoids (starting dose of 25 mg/day tapered to 2.5 mg/day by Week 16).
  • The data showed an improved safety profile over the first six months of treatment with LUPKYNIS® in combination with low-dose glucocorticoids and lower-dose MMF without compromising efficacy.
  • Additional data assessed the disposition of cyclosporine (CSA), tacrolimus (TAC), and voclosporin (VCS) in mouse kidneys relative to its systemic drug exposure.

Eledon Reports Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

Retrieved on: 
Thursday, November 2, 2023

IRVINE, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing de novo kidney transplantation. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023.

Key Points: 
  • ET
    IRVINE, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing de novo kidney transplantation.
  • Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023.
  • There have been no cases of hyperglycemia, new onset diabetes, tremor, or cytomegalovirus infection commonly seen with tacrolimus.
  • In September, Eledon announced that the first participant had been dosed in the Company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

Eledon Pharmaceuticals Announces Use of Tegoprubart anti-CD40L Antibody in Second-ever Transplant of Genetically Modified Heart from a Pig to a Human

Retrieved on: 
Monday, September 25, 2023

IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.

Key Points: 
  • IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human.
  • The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.
  • “The historic procedure we conducted on our courageous patient brings us to a pivotal moment in the history of organ transplantation.
  • Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.