Immunoglobulin A

Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 18, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Research program, Administration, Congress, Development, WT, Lupus, Patient, Immunoglobulin A, Glomerular filtration rate, SLE, Inflammation, MD, UPCR, Neonatal Fc receptor, American College, Investment, Clinical trial, Society, EGFR, Nephrology, BAFF, Proteinuria, Immunoglobulin G, Autoimmunity, ALPN, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.
  • “2023 was a transformational year for Alpine, with initial IgA nephropathy (IgAN) data presented at the American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor.
  • In addition, povetacicept was well tolerated during subcutaneous administration, with no instances of IgG
  • Net Loss: Net loss for the year ended December 31, 2023, was $32.2 million compared to $57.8 million for the same period in 2022.

HI-Bio Receives FDA Orphan Drug Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients

Retrieved on: 
Thursday, March 21, 2024
ODD, AMR, SAN, Patient, IgA nephropathy, FDA, Immunoglobulin A, Manufacturing execution system, Disease, Food, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 21, 2024 /PRNewswire/ -- Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for felzartamab for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 21, 2024 /PRNewswire/ -- Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for felzartamab for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.
  • "Following the FDA's granting of Breakthrough Therapy Designation for felzartamab in primary membranous nephropathy, we are encouraged to receive Orphan Drug Designation for felzartamab for antibody-mediated rejection," said Uptal Patel, M.D., Chief Medical Officer at HI-Bio.
  • "Along with our academic collaborators, we look forward to submitting clinical data from the ongoing study of felzartamab in antibody-mediated rejection to a medical conference this year.
  • Orphan Drug Designation qualifies HI-Bio for certain development incentives, including tax credits for qualified clinical trials, exemption of FDA application fees and up to seven-year market exclusivity upon regulatory approval.

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
Angiotensin, SAN, European Commission, EMA, Erosion (morphology), Committee, New Drug Application, PROTECT, FDA, Food, Dialysis, Shanda, Hope, Risk, Civil service commission, Therapy, CHMP, CSL Vifor, EGFR, Patient, Immunoglobulin A, Kidney disease, Disease, Kidney, CMA, Proteinuria, Pharmaceutical industry

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.

Molecular Templates, Inc. Provides Interim Update

Retrieved on: 
Monday, March 4, 2024
Therapy, Head, Neoplasm, Neck, CLS, AML, Part, TME, Sale, Pembrolizumab, Multiple myeloma, Bristol Myers Squibb, Symantec Endpoint Protection, TPS, Hyponatremia, Cytokine, Hypertension, Tumor microenvironment, Patient, Immunoglobulin A, MD Anderson Cancer Center, Hyperlipidemia, Disease, Biology, HNSCC, Hypercholesterolemia, CPS, PD-L1, Cancer, Pharmaceutical industry

Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.

Key Points: 
  • Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.
  • MTEM intends to initiate a study of MT-0169 in CD38+ acute leukemias in collaboration with MD Anderson Cancer Center.
  • Additional details on each of these participant’s clinical profile and response to the investigational treatment are provided below.
  • MTEM plans on initiating an investigator sponsored trial with MD Anderson Cancer Center to evaluate MT-0169 in relapsed or refractory CD38+ AML patients.

Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

Retrieved on: 
Friday, February 23, 2024
Head, SAN, European Commission, EMA, Marketing, Irbesartan, MAA, European, Food, CSL, Risk, Civil service commission, Therapy, CHMP, CSL Vifor, Patient, Immunoglobulin A, Kidney disease, Kidney, CMA, Proteinuria, Kidney failure, Pharmaceutical industry

SAN DIEGO, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). IgAN is a rare kidney disease and a leading cause of kidney failure. The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan. If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.

Key Points: 
  • The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan.
  • If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.
  • In August 2022, Travere Therapeutics and CSL Vifor announced they had submitted a Marketing Authorization Application (MAA) for CMA to the EMA.
  • In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand.

Novel Research Illuminates Breast Milk's Unique Contribution to COVID-19 Defense in Infants

Retrieved on: 
Tuesday, March 5, 2024
Research, Immunoglobulin G, Molecular biology, Immunoglobulin A, Infection, Infant, Antibody, Conference, Vaccination, University, Saliva, COVID-19, Milk, University of California, Breast milk, Science, Vaccine

LISBON, Portugal, March 5, 2024 /PRNewswire/ -- The International Conference on Human Milk Science and Innovation (ICHMSI) has announced that Dr. Yarden Golan Maor is the fifth recipient of the Ruth A. Lawrence Investigator Award for Research in Human Milk Science.

Key Points: 
  • Dr. Golan's research, titled " Milk antibody response after 3rd COVID-19 vaccine and SARS-CoV-2 infection and implications for infant protection ," analyzed antibodies in breast milk following vaccination and breakthrough infection.
  • Infant saliva also contained more abundant immunoglobulin A (IgA) from breast milk than immunoglobulin G (IgG), and IgA persisted longer post-feeding.
  • Her research highlights antibody transfer to infants through breastfeeding, strengthening the understanding of breast milk's role against infectious diseases.
  • She has over 10 years of experience in molecular biology and nutrition, and her research focuses on human milk science.

Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy

Retrieved on: 
Friday, February 16, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Chronic kidney disease, Commercialization, Caregiver, Multimedia, Food, BLA, Medication, IgA nephropathy, Risk, RAAS, OPDC, Life expectancy, Otsuka Pharmaceutical, Patient, Immunoglobulin A, Disease, Breakthrough therapy, Biology, Kidney failure, Pharmaceutical industry

Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC); Otsuka Pharmaceutical, Co. Ltd. (Otsuka); and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease).

Key Points: 
  • Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC); Otsuka Pharmaceutical, Co. Ltd. (Otsuka); and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease).
  • This press release features multimedia.
  • Breakthrough therapy designation allows the agency to prioritize and focus resources on the most promising products for which no satisfactory treatment option exists.
  • “We are encouraged by the FDA’s decision to grant breakthrough therapy status for the sibeprenlimab program,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka.

Grifols announces positive topline phase 3 fibrinogen clinical trial results

Retrieved on: 
Wednesday, February 14, 2024
Acquisition, Liver, Bleeding, MCE, USD, SCAP, Immunoglobulin M, FC, Fibrinogen, Wound healing, Standard of care, Fibrin, Risk, Safety, Immunoglobulin G, Element, GRFS, Medicine, Patient, Immunoglobulin A, AFD, Clinical trial, Protein, GRF, Plasma, Factor, CAP, Community-acquired pneumonia, Pharmaceutical industry

AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.

Key Points: 
  • AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.
  • Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing.
  • “The positive results for Biotest’s fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” said Victor Grifols Deu, Grifols Chief Operating Officer.
  • The acquisition of Biotest has significantly reinforced Grifols’ access to plasma, as well as the company’s pipeline and sales presence.

Calliditas provides patent update

Retrieved on: 
Tuesday, February 13, 2024
Orange Book, Sustainability, Capsule, Person, Budesonide, Patent, CALT, Immunoglobulin A, IgA nephropathy, The Orange Book

STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.

Key Points: 
  • STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.
  • This is Calliditas' second patent for TARPEYO in the United States, and provides product protection until 2043.
  • The patent covers a method of treating IgA nephropathy with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name "NEFECON®".
  • Calliditas intends to file corresponding patent applications in additional territories around the world, including Europe and China.

Calliditas provides patent update

Retrieved on: 
Tuesday, February 13, 2024
Orange Book, Sustainability, Capsule, Person, Budesonide, Patent, CALT, Immunoglobulin A, IgA nephropathy, The Orange Book

STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.

Key Points: 
  • STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.
  • This is Calliditas' second patent for TARPEYO in the United States, and provides product protection until 2043.
  • The patent covers a method of treating IgA nephropathy with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name "NEFECON®".
  • Calliditas intends to file corresponding patent applications in additional territories around the world, including Europe and China.