Nephrology Dialysis Transplantation

ObsEva Announces UK MHRA Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

Retrieved on: 
Tuesday, June 28, 2022
SIX Swiss Exchange, Patient, Gynaecology, Marketing, Company, Hormone, Birth, MHRA, Royal commission, Birth certificate, Quality of life, Urology, Osteoporosis, Drug development, Nasdaq, Pregnancy, Coronavirus, Uterine fibroid, NDA, Security (finance), FDA, European, ABT, Woman, Anemia, Nephrology Dialysis Transplantation, Uterus, SEC, Risk, Central Research Laboratories, Solution, CEO, Report, New Drug Application, Linzagolix, European Commission, Menopause, Investor, Private Securities Litigation Reform Act, Health, U.S. Securities and Exchange Commission, NASDAQ, Mental health, Bloating, Review, Anxiety, Fertility, Adult, Pain, Theramex, Endometriosis, Gonadotropin-releasing hormone, PDUFA, Medicines and Healthcare products Regulatory Agency, Medical device, Pharmaceutical industry, Birth control, EU, Kissei, UF

Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.

Key Points: 
  • Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.
  • The MHRA approval follows the granting of marketing authorization by the European Commission earlier in June 2022.
  • For women with UF who cannot or do not want to take hormones, Yselty is the first and only approved oral GnRH antagonist with a non-hormonal dosing option.
  • As the first and only approved GnRH antagonist to offer flexible dosing options with and without additional hormonal therapy, we hope to redefine care for women suffering from uterine fibroids.

Theramex Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Symptoms of Uterine Fibroids

Retrieved on: 
Friday, June 17, 2022
Medical Supplies, Health, Consumer, Women, Pharmaceutical, Biotechnology, Solution, Gonadotropin-releasing hormone, Fertility, Uterine fibroid, Nasdaq, CHMP, Menopause, Contraindication, Endometriosis, Urology, Theramex, Central Research Laboratories, Pregnancy, Linzagolix, SIX Swiss Exchange, Kissei, Birth, Committee, Physician, Health, Nephrology Dialysis Transplantation, European Commission, European Directive on Traditional Herbal Medicinal Products, Partnership, Adult, Patient, Life, Committee for Medicinal Products for Human Use, Osteoporosis, ABT, Woman, EC, Pharmaceutical industry, UF, EU

The European Commission (EC) has granted Marketing Authorization for Yselty (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age.

Key Points: 
  • The European Commission (EC) has granted Marketing Authorization for Yselty (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age.
  • The EC decision follows the Committee for Medicinal Products for Human Use (CHMP) confirmation of positive opinion in April 2022.
  • Linzagolix is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.
  • Uterine Fibroids affect 25% of women within reproductive age, many with severe symptoms requiring surgery.

ObsEva Announces Additional Efficacy Results for Linzagolix 200 mg with Add-Back Therapy (ABT) and Linzagolix 75 mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Tuesday, March 22, 2022
EAP, Private Securities Litigation Reform Act, Menstrual cycle, Drug development, Nephrology Dialysis Transplantation, Risk, Norethisterone, Dyspareunia, Investor, Analgesic, SIX Swiss Exchange, Ovulation, EDELWEISS, Fertility, Clinical trial, Infertility, Birth certificate, Coronavirus, Uterine fibroid, Constipation, Urology, Pelvic pain, SEC, Pregnancy, Uterus, Research, Woman, Endometrium, Patient, CEO, Gonadotropin-releasing hormone, Pain, Gynaecology, Security (finance), Sexual intercourse, Safety, Defecation, ABT, Estradiol, U.S. Securities and Exchange Commission, Dysmenorrhea, Endometriosis, Nasdaq, Linzagolix, Fatigue, Disease, Pharmaceutical industry, Birth control, Kissei

EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.

Key Points: 
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.
  • Results from the post-treatment follow-up of EDELWEISS 3 are expected in early 3Q2022.
  • Results from the treatment phase of the extension study (EDELWEISS 6) and its post-treatment follow-up phase are expected in early 3Q2022 and 4Q2022, respectively.

ObsEva Announces Additional Efficacy Results for Linzagolix 200 mg with Add-Back Therapy (ABT) and Linzagolix 75 mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Tuesday, March 22, 2022
EAP, Private Securities Litigation Reform Act, Menstrual cycle, Drug development, Nephrology Dialysis Transplantation, Risk, Norethisterone, Dyspareunia, Investor, Analgesic, SIX Swiss Exchange, Ovulation, EDELWEISS, Fertility, Clinical trial, Infertility, Birth certificate, Coronavirus, Uterine fibroid, Constipation, Urology, Pelvic pain, SEC, Pregnancy, Uterus, Research, Woman, Endometrium, Patient, CEO, Gonadotropin-releasing hormone, Pain, Gynaecology, Security (finance), Sexual intercourse, Safety, Defecation, ABT, Estradiol, U.S. Securities and Exchange Commission, Dysmenorrhea, Endometriosis, Nasdaq, Linzagolix, Fatigue, Disease, Pharmaceutical industry, Birth control, Kissei

EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.

Key Points: 
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.
  • Results from the post-treatment follow-up of EDELWEISS 3 are expected in early 3Q2022.
  • Results from the treatment phase of the extension study (EDELWEISS 6) and its post-treatment follow-up phase are expected in early 3Q2022 and 4Q2022, respectively.

ObsEva Provides Update on EU Marketing Authorisation Process for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

Retrieved on: 
Friday, February 4, 2022
NASDAQ, Private Securities Litigation Reform Act, Pain, Report, European Medicines Agency, Linzagolix, New Drug Application, Investor, PDUFA, Uterine fibroid, Gonadotropin-releasing hormone, U.S. Securities and Exchange Commission, Clinical trial, Birth certificate, Risk, FDA, Patient, Review, Endometriosis, Security (finance), Urology, SEC, Nephrology Dialysis Transplantation, EMA, SIX Swiss Exchange, Coronavirus, Gynaecology, Drug development, Pregnancy, Nasdaq, Pharmaceutical industry, Kissei

ObsEva is in dialogue with the EMA to understand areas that may require further clarification and is committed to promptly addressing any questions that could arise.

Key Points: 
  • ObsEva is in dialogue with the EMA to understand areas that may require further clarification and is committed to promptly addressing any questions that could arise.
  • Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile1,2,3.
  • Linzagolix has completed clinical trial development for the treatment of uterine fibroids and is currently in late-stage clinical development for the treatment of pain associated with endometriosis.
  • ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product.

Treatment for Critically Ill COVID Patients Results in Significant Improvement in Survival Rate According to New Study

Retrieved on: 
Tuesday, January 11, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Medical Devices, Infectious Diseases, Seraph, Heparin, Survival, Sepsis, Patient, News, Jean-Louis Vincent, Survival rate, Intubation, Person, COVID-19, Virus, EUA, Transplant, Â, Pandemic, Bacteria, Infection, DARPA, CE, Nephrology Dialysis Transplantation, Communication, COSA, Treatment, FDA, Subclinical infection, Hospital, Omicron, COVID, Fungus, ICU, Pharmaceutical industry, EU, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

Few treatments are available for critically ill COVID patients in the ICU.

Key Points: 
  • Few treatments are available for critically ill COVID patients in the ICU.
  • In addition, patients treated earlier in their ICU with the Seraph 100 may avoid intubation and mechanical ventilation.
  • The new findings, published in Nephrology Dialysis Transplantation , found:
    There is still a need for therapeutic treatment options, especially in critically ill patients, as COVID variants such as Omicron continue to emerge.
  • ExThera Medicals extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis and other severe infections.

ObsEva Announces Positive Topline Results for Linzagolix 200 mg with Add-Back Therapy in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Thursday, January 6, 2022
ID, EMA, Clinical trial, Endometriosis, Safety, Pelvic pain, Pregnancy, Urology, Uterine fibroid, Estradiol, Endometrium, Menstrual cycle, Sexual intercourse, Birth certificate, Investor, SIX Swiss Exchange, Patient, Uterus, Fertility, Dysmenorrhea, Nephrology Dialysis Transplantation, Gonadotropin-releasing hormone, Analgesic, BMD, Security (finance), Report, Risk, Private Securities Litigation Reform Act, Gynaecology, Central European Time, Disease, CEO, EAP, SEC, Norethisterone, Research, FDA, EDELWEISS, Woman, Infertility, Pain, Defecation, ABT, Dyspareunia, U.S. Securities and Exchange Commission, Drug development, Constipation, Headache, Linzagolix, Fatigue, Nasdaq, Coronavirus, Ovulation, Pharmaceutical industry, Birth control, Kissei

ObsEva will host a conference call and audio webcast with Dr. Hugh Taylor today, January 6 at 8:00 a.m. Eastern Time/2:00 p.m. Central European Time to discuss Phase 3 EDELWEISS 3 trial results of linzagolix.

Key Points: 
  • ObsEva will host a conference call and audio webcast with Dr. Hugh Taylor today, January 6 at 8:00 a.m. Eastern Time/2:00 p.m. Central European Time to discuss Phase 3 EDELWEISS 3 trial results of linzagolix.
  • Investors may participate by dialing 1-877-407-9208 for U.S. callers or +1-201-493-6784 for international callers and refer to conference ID 13725902.
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.

ObsEva Announces Positive Topline Results for Linzagolix 200 mg with Add-Back Therapy in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Thursday, January 6, 2022
ID, EMA, Clinical trial, Endometriosis, Safety, Pelvic pain, Pregnancy, Urology, Uterine fibroid, Estradiol, Endometrium, Menstrual cycle, Sexual intercourse, Birth certificate, Investor, SIX Swiss Exchange, Patient, Uterus, Fertility, Dysmenorrhea, Nephrology Dialysis Transplantation, Gonadotropin-releasing hormone, Analgesic, BMD, Security (finance), Report, Risk, Private Securities Litigation Reform Act, Gynaecology, Central European Time, Disease, CEO, EAP, SEC, Norethisterone, Research, FDA, EDELWEISS, Woman, Infertility, Pain, Defecation, ABT, Dyspareunia, U.S. Securities and Exchange Commission, Drug development, Constipation, Headache, Linzagolix, Fatigue, Nasdaq, Coronavirus, Ovulation, Pharmaceutical industry, Birth control, Kissei

We remain dedicated to providing flexible treatment options for women and look forward to further development of linzagolix in the endometriosis indication.

Key Points: 
  • We remain dedicated to providing flexible treatment options for women and look forward to further development of linzagolix in the endometriosis indication.
  • Investors may participate by dialing 1-877-407-9208 for U.S. callers or +1-201-493-6784 for international callers and refer to conference ID 13725902.
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.

CG Oncology Announces First Patient Dosed in Japan in Phase 3 Monotherapy Study of CG0070 in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin

Retrieved on: 
Monday, December 20, 2021
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Bladder cancer, Nephrology Dialysis Transplantation, Kissei, NMIBC, Drug discovery, Safety, Patient, Pembrolizumab, BCG, Nivolumab, CG, Urology, Pharmaceutical industry, CG Oncology, Kissei Pharmaceutical Co., Ltd., CG ONCOLOGY, KISSEI PHARMACEUTICAL CO., LTD.

The goal of BOND3, an ongoing global Phase 3 trial which will enroll 110 patients, is to evaluate the safety and efficacy of CG0070 as a monotherapy for the treatment of NMIBC unresponsive to BCG.

Key Points: 
  • The goal of BOND3, an ongoing global Phase 3 trial which will enroll 110 patients, is to evaluate the safety and efficacy of CG0070 as a monotherapy for the treatment of NMIBC unresponsive to BCG.
  • CG Oncology is a clinical-stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer.
  • Our lead candidate, CG0070, is a selective oncolytic immunotherapy in a Phase 3 trial with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a combination Phase 2 study of CG0070 with KEYTRUDA (pembrolizumab) in the same indication.
  • At CG Oncology, we aim to take the next evolutionary step in delivering innovative cancer care to millions of patients in need worldwide.

VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan

Retrieved on: 
Monday, September 27, 2021
Biotechnology, General Health, Pharmaceutical, Health, ISIN, Hyperphosphatemia, Cyclophosphamide, Vasculitis, Standard of care, SIX Swiss Exchange, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Population, Death, Nephrology Dialysis Transplantation, Rituximab, Urology, Cell, Microscopic polyangiitis, Nephrology, EMA, Food, Steroid, Failure, European Medicines Agency, Degenerative disease, Receptor (biochemistry), Kidney, MAA, CEO, Granuloma, Disease, Conditional sentence, ANCA, NHI, History, Fresenius Medical Care, Neutrophil, European Commission, C5a, Inflammation, Cancer, Anti-neutrophil cytoplasmic antibody, End organ damage, Marketing, HS, MHLW, Infection, Time, Hidradenitis suppurativa, Kissei, Patient, GPA, Granulomatosis with polyangiitis, Atypical hemolytic uremic syndrome, Vifor Pharma, C5L2, MPA, Pharmaceutical industry, Vifor Pharma Group, Kissei Pharmaceutical Co., Ltd., ChemoCentryx Inc., ANCA-associated vasculitis, TAVNEOS® (avacopan), VIFOR PHARMA GROUP, KISSEI PHARMACEUTICAL CO., LTD., CHEMOCENTRYX INC., ANCA-ASSOCIATED VASCULITIS, TAVNEOS® (AVACOPAN)

ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required.

Key Points: 
  • ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required.
  • There is significant unmet medical need of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS for treating it.
  • TAVNEOS demonstrated superiority over standard of care at week 52 based on Birmingham Vasculitis Activity Score (BVAS).
  • In June 2017, VFMCRP granted Kissei the exclusive right to develop and commercialize TAVNEOS in Japan.