Erythema

argenx Highlights Data Evaluating VYVGART in Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions

Retrieved on: 
Wednesday, November 1, 2023
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Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections.

Key Points: 
  • Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections.
  • If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.
  • Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
  • If a hypersensitivity reaction occurs during VYVGART or VYVGART HYTRULO administration, discontinue use and institute appropriate supportive measures if needed.

Anaptys Announces Positive Top-Line Phase 3 Clinical Trial Results of Imsidolimab (IL-36R) in Generalized Pustular Psoriasis (GPP)

Retrieved on: 
Monday, October 9, 2023
ADA, Incidence, Antibody, Food, Autoimmunity, Aes, BLA, Therapy, Data, Safety, DRESS, FDA, Flare, Immunoglobulin G, MENA, Immune system, SAN, Patient, Guillain–Barré syndrome, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GPP, Erythema, Inflammation, Infection, Pharmaceutical industry, Medical imaging, Vaccine, Medical device, EU

Investigational imsidolimab met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab.

Key Points: 
  • Investigational imsidolimab met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab.
  • “The success of the GEMINI-1 trial highlights Anaptys’ commitment to patients and our ability to internally discover and develop differentiated antibodies,” said Daniel Faga, president and chief executive officer of Anaptys.
  • The registration-enabling GEMINI-1 trial in GPP, which recruited 45 patients, is the first randomized, double-blind, placebo-controlled trial to use the composite endpoint of Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) at Week 4 as its primary assessment.
  • Patients were randomized 1:1:1 to receive a single infusion of 750mg IV imsidolimab, 300mg IV imsidolimab or placebo at Day 0.

Seagen to Highlight Overall Survival Data for PADCEV® and TIVDAK® during Presidential Symposium at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, Fatal, Weakness, Female, Skin, PD-L1, Creatinine, DKA, Nausea, Swelling, Keratitis, Pneumonia, Birth, PD-1, Hair, Neutrophil, Male, Peripheral neuropathy, Lipase, Acute kidney injury, Blood, Stevens–Johnson syndrome, Toxic epidermal necrolysis, Diabetic neuropathy, Toxicity, Bulla, Temperature, Appetite, Itch, SJS, Fetus, Cornea, Conjunctivitis, Hyperglycemia, Dermatitis, Evaluation, Hypoxia, Pain, Diabetic ketoacidosis, Pembrolizumab, ILD, Risk, Liver, Lymphocyte, Grade 2, Rash, Erythema, Fatigue, Acral lentiginous melanoma, Pneumonitis, Papule, Incidence, Dysgeusia, Anemia, Cough, Urinary tract infection, Diarrhea, Erythroderma, Periodic breathing, TEN, Patient, MUC, PN, Drug eruption, Septic shock, Pharmaceutical industry, Medical imaging, Palladium

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Key Points: 
  • Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.
  • When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate.
  • Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCEV in combination with pembrolizumab in clinical trials.
  • The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.

Inozyme Pharma Announces Positive Interim Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE)

Retrieved on: 
Tuesday, September 26, 2023
PROMIS, BMC, Pros, Pediatric emergency medicine, Pediatrics, PD, Therapy, Hypophosphatemia, BSAP, Fatigue, Medicine, Phase II, New Çeltek events, Biomarker, BMD, Appetite, Hives, Pyrophosphate, Parallel Walk Test, Rapids, Alkaline phosphatase, Pain, Bruise, ET, Clinical trial, Bleeding, ADAS, Patient, Physician, PXE, Swelling, Itch, Erythema, Division, Adolescence, Osteomalacia, Infant, DEXA, Rickets, GIC, ADA, Diabetes, Titanium metallic discoloration, Safety, Dietary supplement, Pharmaceutical industry, Nursing, Medical imaging, Phosphorus, Birth control, Risk management, Vaccine, Endocrinology, News

BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive interim safety, pharmacokinetic (PK), pharmacodynamic (PD) and exploratory efficacy data from the Company’s ongoing Phase 1/2 clinical trials of INZ-701 in adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE, pseudoxanthoma elasticum).

Key Points: 
  • For trial design details, please see the section entitled “INZ-701 in ENPP1 Deficiency Phase 1/2 Clinical Trial Design” below.
  • Exploratory biomarker data were collected throughout the study to provide evidence of the potential for disease modification with ongoing treatment with INZ-701.
  • For trial design details, please see the section entitled “INZ-701 in ABCC6 Deficiency Phase 1/2 Clinical Trial Design” below.
  • PK properties were consistent with those observed in the Phase 1/2 clinical trial in adults with ENPP1 Deficiency.

scPharmaceuticals Announces Positive Feedback from Two FDA Meetings on Key Long-Term Growth Initiatives

Retrieved on: 
Tuesday, September 19, 2023
Overload, Furosemide, PK, Hypersensitivity, NYHA, Congestion, Embolism, Hypoproteinemia, Organic acid, Heart failure, Hospital, Urine, Creatinine, Cirrhosis, Dehydration, Glucose, Tinnitus, Deafness, Huber loss, Edema, Hepatic encephalopathy, Oliguria, History, Solubility, Type, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Shanda, Investigational New Drug, HIV disease progression rates, Patent, Patient, Physician, Ototoxicity, Urinary retention, Erythema, Azotemia, Ascites, Coma, Type D, Growth, Diagnosis, Blood volume, FDA, Benign prostatic hyperplasia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Cerebral edema, CO2, Thrombosis, BUN, Food, Kidney disease, Anuria, Pharmaceutical industry

BURLINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives.

Key Points: 
  • The Company also announced today feedback from a Type D meeting with the FDA pertaining to the potential expansion of the FUROSCIX label to include treatment of edema due to fluid overload in patients with CKD.
  • In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that the Company demonstrates an adequate PK and pharmacodynamic bridge to the listed drug, furosemide injection, 10 mg/mL.
  • CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics.
  • “We are very pleased to have reached alignment with the FDA on the advancement of these two very important long-term growth initiatives for our company,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.

AlgoTx Announces First Patients Dosed in US and European Arms of Phase II Clinical Trial of ATX01 in Rare Disease Erythromelalgia

Retrieved on: 
Tuesday, September 12, 2023
ACT, Crossover study, Mayo, Chemotherapy-induced peripheral neuropathy, Extremities, Therapy, Face, Safety, Efficacy, Quality of life, Toxicity, Research, CIPN, EMA, Pain, Dermatology, Erythema, Patient, Swelling, EASE, FDA, Skin temperature, Peripheral nervous system, Pharmaceutical industry, Dentistry, Erythromelalgia

Under Orphan Drug Designation from FDA and EMA, this trial investigates the efficacy of the company’s lead asset ATX01 on the pain of Erythromelalgia, a rare neurological and vascular disease characterized by painful extremities for which there is no available treatment.

Key Points: 
  • Under Orphan Drug Designation from FDA and EMA, this trial investigates the efficacy of the company’s lead asset ATX01 on the pain of Erythromelalgia, a rare neurological and vascular disease characterized by painful extremities for which there is no available treatment.
  • I am delighted to be leading the European part of the phase II clinical trial of ATX01.”
    The Mayo Clinic’s Julio Sartori Valinotti MD is involved in the research in the U.S.
  • This condition primarily affects the feet, and less commonly, the hands, arms, legs, ears, and face.
  • It is characterized by intense, burning pain, increases in skin temperature, swelling and severe redness (erythema) of the affected extremities.

BioLineRx Announces FDA Approval of APHEXDA™ (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma

Retrieved on: 
Monday, September 11, 2023
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TEL AVIV, Israel, Sept. 11, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA is administered by injection, for subcutaneous use.

Key Points: 
  • Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9174951-biolinerx-fda-approval-a...
    Multiple myeloma is the second most-common hematologic malignancy.
  • Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and delivers prolonged survival for patients with this cancer type.1 The success of ASCT depends on adequate mobilization of stem cells during the treatment process.
  • Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose.
  • In GENESIS, the safety was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim, and 42 patients who received placebo plus filgrastim.

Recce Pharmaceuticals Completes Stage 1 Data Analysis of Phase I/II Clinical Trial for the Treatment of Burn Wound Infections

Retrieved on: 
Wednesday, August 23, 2023
Regulation of therapeutic goods, Infection, Antimalarial medication, Clinical trial, Foot, ASX, FSE, COVID, Burn, 2018 Vuelta a España, Stage 1 to Stage 11, Erythema, Patient, Swelling, Observation, Genetically modified bacteria, Burns, TGA, Safety, RCE, Pharmaceutical industry

“We thank the West Australian Government for sponsoring this investigator-led topical burn wound infection trial,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

Key Points: 
  • “We thank the West Australian Government for sponsoring this investigator-led topical burn wound infection trial,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • “The patient data received has paved the way to advance this new class of anti-infective as a topical application against deadly bacterial pathogens and a broad range of infectious diseases.
  • Endpoints of the trial include clinical wound assessment, graded for specific parameters such as erythema, hyper granulation, swelling, and discharge, and microbial cultures of wound swabs.
  • Stage 2 of the clinical trial is expected to be a randomized ‘head-to-head’ study in patients with infected burn wounds, where R327G will be compared to the current standard of care.

TheracosBio and SmithRx Collaborate to Offer Newly Approved Diabetes Drug Brenzavvy™ (bexagliflozin) to Members with Type 2 Diabetes

Retrieved on: 
Thursday, August 17, 2023
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Working with TheracosBio and Cost Plus Drugs, SmithRx now provides BRENZAVVY as an option following its launch in July 2023.

Key Points: 
  • Working with TheracosBio and Cost Plus Drugs, SmithRx now provides BRENZAVVY as an option following its launch in July 2023.
  • BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
  • Diabetes is the most expensive chronic condition in the U.S. and accounts for 1 of every 4 dollars spent on healthcare.
  • In patients with type 1 diabetes mellitus, BRENZAVVY significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond background rate.

scPharmaceuticals Inc. Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 10, 2023
Hypersensitivity, Furosemide, NYHA, Congestion, Embolism, Medicaid, Hypoproteinemia, Organic acid, Heart failure, Urine, Creatinine, Patient satisfaction, Cirrhosis, Dehydration, Tinnitus, Glucose, Deafness, Huber loss, Edema, Hepatic encephalopathy, Prescription, Research, Part, Oliguria, History, Government, Russell 3000 Index, Trial of the century, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Investment, Patient, Russell, Urinary retention, Cardiology, Azotemia, Ascites, Coma, Blood volume, FDA, Benign prostatic hyperplasia, Thrombosis, IND, Cerebral edema, CO2, BUN, Anuria, Security (finance), Cryptocurrency, Pharmaceutical industry, Health insurance, Medical device, Video game, BURLINGTON

BURLINGTON, Mass., Aug. 10, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the second quarter ended June 30, 2023, and provided a business update. 

Key Points: 
  • For the second quarter ended June 30, 2023, scPharmaceuticals reports:
    Obtained national Medicaid coverage of FUROSCIX effective July 1, 2023.
  • Ended the second quarter of 2023 with cash, cash equivalents and short-term investments of $102.9 million.
  • Research and development expenses were $2.9 million for the second quarter of 2023, compared to $5.1 million for the second quarter of 2022.
  • Selling, general and administrative expenses were $12.1 million for the second quarter of 2023, compared to $4.3 million for the second quarter of 2022.