Injection site reaction

Alnylam Submits Regulatory Applications to the U.S. Food and Drug Administration and European Medicines Agency to Support Label Expansion for OXLUMO® for the Treatment of Advanced Primary Hyperoxaluria Type 1

Retrieved on: 
Tuesday, December 14, 2021
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Genetics, Clinical Trials, PH1, Dialysis, Itch, Food, Shanda, FDA, Injection site reaction, EGFR, CKD, European Medicines Agency, Pain, Child, Swelling, Alnylam Pharmaceuticals, Pregnancy, New Drug Application, Therapeutic index, ASN, Adult, Milk, Nasdaq, GO, EMA, Enhance, Hydroxyacid oxidase (glycolate oxidase) 1, Plasma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medication, General manager, Safety, Patient, Therapy, Profile, Society, Kidney, Chronic kidney disease, Erythema, HAO1, ESC, RNA interference, American Society of Nephrology, Skin, Heart, Pharmaceutical industry, Birth control

OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

Key Points: 
  • OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
  • The most common adverse reaction that occurred in patients treated with OXLUMO was injection site reaction (38%).
  • No data are available on the presence of OXLUMO in human milk or its effects on breastfed infants or milk production.
  • Lumasiran is a subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) in development for the treatment of advanced primary hyperoxaluria type 1 (PH1).

Greenwich LifeSciences Provides Clinical Update on Upcoming Phase III Clinical Trial, FLAMINGO-01

Retrieved on: 
Wednesday, November 10, 2021
Pharmaceutical, Health, Oncology, Clinical Trials, Population, Phase, Biopharmaceutical, Breast, HER2/neu, MD Anderson Cancer Center, Recurrence, Prospectus, Survivor, Arm, Injection site reaction, BLA, Immunotherapy, Forward-looking statement, Trastuzumab, Lists of people executed in the United States, Cancer, Woman, DTH, Twitter, Company, Breast cancer, SEC, HR, Physician, HLA, Greenwich, Nasdaq, Patient, FDA, Pharmaceutical industry, Vaccine, FLAMINGO-01 and GLSI-100, Breast Cancer and HER2/neu Positivity, Greenwich LifeSciences, Inc., GP2 Immunotherapy Immune Response, FLAMINGO-01 AND GLSI-100, BREAST CANCER AND HER2/NEU POSITIVITY, GREENWICH LIFESCIENCES, INC., GP2 IMMUNOTHERAPY IMMUNE RESPONSE

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the Company), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provides an update on the upcoming Phase III clinical trial FLAMINGO-01.

Key Points: 
  • Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the Company), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provides an update on the upcoming Phase III clinical trial FLAMINGO-01.
  • Thus, we plan to continue to publish Phase IIb and Phase III trial data at conferences throughout the conduct of the Phase III study.
  • The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100.
  • Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.

Alnylam Presents Positive Results from ILLUMINATE-C Phase 3 Study of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1

Retrieved on: 
Friday, November 5, 2021
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, GO, Society, Milk, Safety, Alnylam Pharmaceuticals, AES, American Society of Nephrology, Pregnancy, CKD, Cohort study, Plasma, Kidney, Therapeutic index, Baylor College of Medicine, AUC, General manager, Disease, RNA interference, Swelling, Department, ESC, EGFR, EMA, Food, Profile, European Medicines Agency, Associate professor, Chronic kidney disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Medication, Dialysis, 1991 World Sportscar Championship, Pain, Itch, Hyperoxaluria, Therapy, Diagnosis, Severe cognitive impairment, Enhance, ASN, Hydroxyacid oxidase (glycolate oxidase) 1, PH1, Cardiomyopathy, Nasdaq, Patient, HAO1, Risk, AE, Bone, Child, Injection site reaction, Erythema, Adult, Pharmaceutical industry, Birth control, Lumasiran, ILLUMINATE-C Phase 3 Study, Primary Hyperoxaluria Type 1 (PH1), RNAi, Alnylam Pharmaceuticals, LUMASIRAN, ILLUMINATE-C PHASE 3 STUDY, PRIMARY HYPEROXALURIA TYPE 1 (PH1), RNAI, ALNYLAM PHARMACEUTICALS

PH1 patients progressing to or being diagnosed with end-stage kidney disease often have substantial elevations in plasma oxalate despite intensive hemodialysis.

Key Points: 
  • PH1 patients progressing to or being diagnosed with end-stage kidney disease often have substantial elevations in plasma oxalate despite intensive hemodialysis.
  • ILLUMINATE-C enrolled 21 patients: six patients in Cohort A who did not require dialysis and 15 patients on hemodialysis in Cohort B.
  • OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
  • Lumasiran is a subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) in development for the treatment of primary hyperoxaluria type 1 (PH1).

Silverback Therapeutics Presents Interim Clinical Results from the Ongoing Phase 1/1b Study of SBT6050 Alone or In Combination with Pembrolizumab in Patients with Advanced or Metastatic HER2-Expressing Solid Tumors

Retrieved on: 
Thursday, September 16, 2021
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Infrared spectroscopy correlation table, Hypotension, U.S. Securities and Exchange Commission, Massachusetts, Security (finance), Therapy, HER2, Patient, Trastuzumab, Hypoxia, Immune system, Trial of the century, Conference, CRS, Pembrolizumab, Blood, Tissue (biology), Nasdaq, RECIST, Oncology, Risk, Pertuzumab, Vomiting, Injection site reaction, Disease, Fatigue, II, European Society for Medical Oncology, Neoplasm, Safety, Hospital, Nausea, MD, Chills, Tumor microenvironment, NSCLC, PK, Cytokine release syndrome, Myelocyte, Fever, Population, Massachusetts General Hospital, TLR8, Nature, Mechanism of action, Research, Cancer, News, Pharmacodynamics, Part, Pharmaceutical industry, Medical imaging, Vaccine, SBT6050, Silverback Therapeutics, SBT6050, SILVERBACK THERAPEUTICS

We look forward to moving into expansion cohorts and to expanding our clinical development plan to include combination with standard-of-care trastuzumab-containing regimens.

Key Points: 
  • We look forward to moving into expansion cohorts and to expanding our clinical development plan to include combination with standard-of-care trastuzumab-containing regimens.
  • As of August 1, 2021, 40 patients with advanced or metastatic HER2-expressing or amplified solid tumors were enrolled into the SBT6050-101 trial.
  • The signals of anti-tumor activity are encouraging and its complementary mechanism of action with standard-of-care agents makes SBT6050 attractive for combination regimens.
  • SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.

Allakos Announces Results from a Phase 1 Study of Subcutaneously Administered Lirentelimab (AK002)

Retrieved on: 
Monday, October 26, 2020
Medical specialties, Immunology, Immune system disorders, EOE, Eosinophilic esophagitis, Esophagitis, Injection site reaction

Across all SC and IV lirentelimab cohorts there were no serious adverse events, no injection site reactions, no injection reactions and no infusion-related reactions.

Key Points: 
  • Across all SC and IV lirentelimab cohorts there were no serious adverse events, no injection site reactions, no injection reactions and no infusion-related reactions.
  • The Company will host a conference call and webcast with slides today at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time.
  • The Companys lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE).
  • These documents contain and identify important factors that could cause the actual results forAllakosto differ materially from those contained in Allakos forward-looking statements.

Bayer statement on voluntary recall of two lots of Kogenate® FS antihemophilic factor (recombinant) in the United States

Retrieved on: 
Friday, July 19, 2019
Medical specialties, Medicine, RTT, Organ systems, Injection site reaction, Injection, Allergy

You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS.

Key Points: 
  • You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS.
  • Your body can make antibodies, called "inhibitors," against Kogenate FS, which may stop Kogenate FS from working properly.
  • Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
  • Other common side effects of Kogenate FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device.