Kidney

The World's First ETa-specific Monoclonal Antibody: Gmax Biopharm's GMA131 Approved by the US FDA for Clinical Study on (DKD) Diabetic Kidney Disease

Retrieved on: 
Monday, November 14, 2022
DKD, Health, Kidney, Edema, IDF, Diabetes, Obesity, Chronic kidney disease, Extracellular matrix, G protein-coupled receptor, Proteinuria, US, ERA, PAH, Fibrosis, Eras, Trial of the century, Patient, Hypertensive emergency, Inflammation, Eta, Kidney disease, ESRD, ETB, IND, Pharmaceutical industry

announced today that its application of investigation of New Drug (IND) for GMA131 injection, the first global ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for clinical study on diabetic kidney disease (DKD).

Key Points: 
  • announced today that its application of investigation of New Drug (IND) for GMA131 injection, the first global ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for clinical study on diabetic kidney disease (DKD).
  • Dr. Shuqian Jing, Founder and Chairman of Gmax Biopharm, said, "GMA131 is the first genuine ETa-specific monoclonal antibody developed by Gmax Biopharm.
  • GMA131 is the same molecule as GMA301 which is currently in a Phase Ib trial of pulmonary arterial hypertension (PAH) in China/USA.
  • DKD, the leading cause of chronic kidney disease and end stage renal disease (ESRD), is one of the most important complications of diabetes.

Protect The Kidneys From Overindulgence During The Holidays

Retrieved on: 
Monday, November 14, 2022
People, University, Growth, Recurrence, Kidney, Calcium, Urine, Chronic kidney disease, Stomach, New York University Grossman School of Medicine, Amazon, Physiology, Nephrology, Medicine, Urology, CVS, Holiday, Patient, University School, Life, NYU Langone Hospital — Long Island, Hospital, Sugar, Moonstone, Capsule, Cystinuria, Phosphorus

PITTSBURGH, Penn. , Nov. 14, 2022  /PRNewswire-PRWeb/ -- During the holidays, with special gatherings, parties, dinners, and cookie swaps, it's easy to overindulge. While it's OK to enjoy splurges here and there, it's important to keep the body and organs in balance, especially for those who may be prone to kidney stones. Moonstone Stone Stopper™ is a simple supplement to help prevent kidney stones, keeping the body hydrated and healthier without adding extra sugars or calories to individuals' diets.

Key Points: 
  • PITTSBURGH, Penn., Nov. 14, 2022 /PRNewswire-PRWeb/ -- During the holidays, with special gatherings, parties, dinners, and cookie swaps, it's easy to overindulge.
  • Moonstone Stone Stopper is a simple supplement to help prevent kidney stones, keeping the body hydrated and healthier without adding extra sugars or calories to individuals' diets.
  • Alkali citrate supplementation has been shown to reduce growth and recurrence of calcium-based stones, uric acid stones, and cystine stones.
  • Alkali citrate binds with calcium, which helps prevent the calcium from binding with other molecules to form kidney stones.

ProKidney to Participate in Upcoming Investor Conferences

Retrieved on: 
Friday, November 11, 2022
U.S. Securities and Exchange Commission, Disease, FDA, MHRA, Diagnosis, Renal replacement therapy, Private Securities Litigation Reform Act, Mortality, CKD, EMA, Security (finance), GLOBE, Technology, Research, Risk, Health Canada, Chronic kidney disease, Humanitarian use licenses, Jefferies, Conference, COVID-19, Kidney, Growth, Partnership, Nasdaq, ISI, Marketing, REACT, Pharmaceutical industry, Medical device

WINSTON-SALEM, N.C., Nov. 11, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (ProKidney), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that Dr. Tim Bertram, Chief Executive Officer, will participate in the following upcoming investor conferences:

Key Points: 
  • WINSTON-SALEM, N.C., Nov. 11, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (ProKidney), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that Dr. Tim Bertram, Chief Executive Officer, will participate in the following upcoming investor conferences:
    Jefferies London Healthcare Conference: Dr. Bertram will participate in a fireside chat on Wednesday, November 16, 2022, at 12:20 PM GMT (7:20 AM ET).
  • Evercore ISI 5th Annual HEALTHCONx Virtual Conference: Dr. Bertram will participate in a fireside chat on Thursday, December 1, 2022 at 10:05 AM ET.
  • Investors participating in the conferences who are interested in meeting with ProKidney management may request a meeting by contacting their Jefferies or Evercore ISI representative.
  • ProKidney, a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research.

CareDx Committed to Delivering Clinical Innovation to the Transplant Patient and Physician Community

Retrieved on: 
Friday, November 11, 2022
Health, Hospitals, Surgery, Genetics, Research, Science, Biotechnology, CEO, Lung, Biomarker, Publication, 21st Century Cures Act, Survival, Division, University of Maryland School of Medicine, Annual report, MD, Ecosystem, Neurology, Heart, Research, Degenerative disease, Maryland School, Caregiver, University of Maryland Medical Center, Patient, Act, SEC, DNA, Liver, Kidney, University, Cohort study, Precision medicine, Nasdaq, Time, Department, Department of Medicine – University of Pamplona, Transplant, HLA, Dentistry, Medical device, Nephrology

Prior to AlloSures introduction, dd-cfDNA was one of many non-invasive markers for organ rejection with the potential for clinical use.

Key Points: 
  • Prior to AlloSures introduction, dd-cfDNA was one of many non-invasive markers for organ rejection with the potential for clinical use.
  • At CareDx, we are proud to have taken a leadership role in the field of transplant as very few companies are investing in transplant, let alone being 100 percent focused.
  • For more than twenty years CareDx has invested in transplant innovations to improve long-term allograft outcomes.
  • In addition, CareDx has always conducted further clinical studies to build a robust scientific base of understanding for the transplant physician.

European Commission (EC) Approves LIVTENCITYTM▼ (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Infection And/or Disease That Are Refractory (With or Without Resistance) to One or More Prior Therapies

Retrieved on: 
Friday, November 11, 2022
Research, Surgery, Infectious Diseases, Clinical Trials, Stem Cells, Other Health, Biotechnology, Pharmaceutical, Health, Science, Foscarnet, Transplant, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Degenerative disease, Hospital, Organ transplantation, EEA, Food, Incidence, SOT, CMV, Valganciclovir, Disease, Plasma protein binding, Ganciclovir, EudraCT, Life, Adult, Tablet, Middle East Society for Organ Transplantation, Health Canada, Patient, Cytomegalovirus, Immunosuppression, Infection, Immune system, Safety, TAK, European Commission, Royal commission, EC, Liver, Kidney, Human, Cidofovir, Physician, Dentistry, Pharmaceutical industry, Dietary supplement, Takeda, HSCT, EU

With the EC approval of LIVTENCITY, we are privileged to offer healthcare providers in the EU and EEA* with an additional oral antiviral treatment for post-transplant refractory CMV.

Key Points: 
  • With the EC approval of LIVTENCITY, we are privileged to offer healthcare providers in the EU and EEA* with an additional oral antiviral treatment for post-transplant refractory CMV.
  • CMV DNA levels should be monitored and resistance mutations should be investigated in patients who do not respond to treatment.
  • Serum digoxin concentrations should be monitored, and dose of digoxin may need to be reduced, as needed (see Table 1).
  • Co-administration of maribavir with sensitive BCRP substrates such as rosuvastatin, is expected to increase their exposure and lead to undesirable effects.

Chinook Therapeutics Provides Business Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 10, 2022
LDHA, Lilly, ETA, Method, Serum, CKD, Research, Therapy, Immunoglobulin A, Kidney, EGFR, Chronic kidney disease, SC, Blood pressure, Industry, Blood, 1836 U.S. Patent Office fire, Forward-looking statement, Primary hyperoxaluria, United States Patent and Trademark Office, PH1, Patent, RAS, BNP, European Commission, RNA, SEC, PH2, Cohort, Alport syndrome, Patient, Urine, Tax, COVID-19, Immunoglobulin G, Immunoglobulin M, Nasdaq, Achievement, Clinical trial, Poster, Focal segmental glomerulosclerosis, Trial of the century, GLOBE, FSGS, New Drug Application, ACE, MAD, SAD, SGLT2, Part, Proteinuria, Royal commission, Biomarker, Disease, CVR, Nature, Pharmaceutical industry, Vaccine, Television, UPCR, Chinook, Merck, Evotec, IgA nephropathy, Alport, Atrasentan

SEATTLE, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today provided a business update and reported financial results for the quarter and nine months ended September 30, 2022.

Key Points: 
  • SEATTLE, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today provided a business update and reported financial results for the quarter and nine months ended September 30, 2022.
  • During the third quarter of 2022, we continued advancing our pipeline of clinical and preclinical programs for rare, severe chronic kidney diseases.
  • Quarter and Nine Months Ended September 30, 2022 Financial Results
    Cash Position Cash, cash equivalents and marketable securities totaled $397.7 million at September 30, 2022, compared to $355.1 million at December 31, 2021.
  • Chinook assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Unicycive Completes Enrollment of Pivotal Bioequivalence Study for RENAZORB™ (lanthanum dioxycarbonate), an Investigational Treatment for Hyperphosphatemia in Chronic Kidney Disease (CKD) Patients on Dialysis

Retrieved on: 
Thursday, November 10, 2022
Dialysis, GLOBE, Private Securities Litigation Reform Act, Atherosclerosis, Hyperphosphatemia, LOS, Artery, Osteoporosis, U.S. Securities and Exchange Commission, Fracture, Cardiovascular disease, CKD, Nasdaq, Food, Diabetes, Risk, Chronic kidney disease, Renal osteodystrophy, Bone pain, COVID-19, Mortality, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, ESKD, Bone disease, Kidney, Failure, Coronavirus, Particle-size distribution, Safety, Gastrointestinal tract, Hypertension, Absorption, Biotechnology, Acute kidney injury, Patient, Security (finance), SHPT, RLD, Kidney disease, NDA, FDA, Trial of the century, Pharmaceutical industry, Generic drug

LOS ALTOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has completed the enrollment of subjects in the RENAZORB bioequivalence (BE) study. RENAZORB (lanthanum dioxycarbonate) is an investigational phosphate binding agent utilizing proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in CKD patients on dialysis.

Key Points: 
  • RENAZORB (lanthanum dioxycarbonate) is an investigational phosphate binding agent utilizing proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in CKD patients on dialysis.
  • The study enrolled 40 subjects per treatment arm (a total of 80 subjects enrolled) for 64 evaluable subjects.
  • RENAZORB is an investigational next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis.

Novozymes and LinusBio announce collaboration to accelerate scientific discovery in Biohealth

Retrieved on: 
Thursday, November 10, 2022
Kidney, Probiotic, Health, Method, Enzyme, UNICEF, Gasoline, Public health, Amyotrophic lateral sclerosis, World Health Organization, Lead, Autism, Inflammatory bowel disease, Gastroenterology, Factor X, Medicine, Vol, Data science, Biomarker, Toxicity, Clinical trial, Hypertension, Novozymes, Hair, Conference, World, CEO, Anemia, Injury, CNS, Pharmaceutical industry, Fine chemical, Policy

Novozymes, the world leader in biological solutions, and LinusBio (Linus Biotechnology Inc.), a leader in precision exposome sequencing, today announced the companies are forming a collaboration to test a new, non-invasive technology in a clinical trial.

Key Points: 
  • Novozymes, the world leader in biological solutions, and LinusBio (Linus Biotechnology Inc.), a leader in precision exposome sequencing, today announced the companies are forming a collaboration to test a new, non-invasive technology in a clinical trial.
  • The project will apply LinusBios environmental biodynamics platform, enabling detailed temporal mapping of harmful compound exposure, to a clinical trial of probiotics sponsored by Novozymes human health unit, Novozymes OneHealth.
  • As part of the project, LinusBio will conduct a comprehensive study examining lead and other harmful chemical levels.
  • We are very excited to embark on this groundbreaking venture with Novozymes, says Dr. Manish Arora, co-founder and CEO of LinusBio.

Zenas BioPharma Secures $118 Million to Advance Its Broad Pipeline of Autoimmune Disease Therapeutics

Retrieved on: 
Wednesday, November 9, 2022
Quality of life, IgG4-related disease, GLOBE, Prevalence, Vivo, ENAV, End organ damage, Zenas, Diagnosis, Efficiency, CD19, Shanghai Venture Capital Co., CA, GC, Autoimmunity, Toxicity, Cell, Liver, Biotechnology, Degenerative disease, Patient, Pivotal, Therapy, Kidney, Pancreas, Wellington Management Company, Pharmaceutical industry, Security (finance), Management, Series

WALTHAM, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, today announced proceeds of $118 million in connection with the issuance of Series B preferred shares. In addition to Enavate Sciences, which led the Series B equity financing, new Zenas shareholders include Longitude Capital, Vivo Capital, Rock Springs Capital, Perceptive Advisors, Agent Capital, Pivotal bioVenture Partners and Superstring Capital. Existing investors Fairmount, Wellington Management, Tellus BioVentures, Quan Venture Fund, and Xencor, Inc. also participated in the financing, which included the infusion of new capital as well as the conversion of convertible notes issued to certain of the investors in advance of the closing of the Series B financing.

Key Points: 
  • In addition, the new funding will progress the companys other global autoimmune disease programs into clinical development in 2023.
  • We believe Zenas will successfully commercialize innovative therapies to improve the lives of those facing autoimmune and rare diseases, said James Boylan, Chief Executive Officer of Enavate Sciences.
  • Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world.
  • For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn .

Coherus BioSciences Reports Third Quarter 2022 Results and Provides Business Update

Retrieved on: 
Tuesday, November 8, 2022
GLOBE, Review, Private Securities Litigation Reform Act, Investment, Ranibizumab, U.S. Securities and Exchange Commission, OBI, Biosimilar, Esophagus, Food, Research, Risk, SG, Stomach, Conference call, BLA, COVID-19, Regulation of tobacco by the U.S. Food and Drug Administration, R, Exercise, PD-1, Lung, Breast, COGS, Cancer, Company, United, Conference, Liver, GAAP, Skin, Growth, Therapy, Kidney, Security (finance), Nasopharyngeal carcinoma, CHRS, FDA, Renewable energy, Generic drug, Fine chemical, Pharmaceutical industry, Animal

REDWOOD CITY, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today reported financial results for its fiscal third quarter ended September 30, 2022 and recent business highlights:

Key Points: 
  • ET
    REDWOOD CITY, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), today reported financial results for its fiscal third quarter ended September 30, 2022 and recent business highlights:
    CIMERLI (ranibizumab-eqrn), was approved in August 2022 by the U.S. Food and Drug Administration (FDA) as a biosimilar product interchangeable with Lucentis (ranibizumab injection), with 12 months of interchangeability exclusivity.
  • Coherus and partner Junshi Biosciences are currently engaged in discussions with the FDA regarding opportunities to complete the inspections.
  • COGS for the third quarter and first nine months of 2021 included thewrite-down of $5.2 million of inventory that did not meet Coherus acceptance criteria.
  • Coherus results for the quarter ended September 30, 2022 are not necessarily indicative of our operating results for any future periods.