Bone pain

Capivasertib Plus FASLODEX® (fulvestrant) Reduced the Risk of Disease Progression or Death by 40% Versus FASLODEX in Advanced HR-Positive Breast Cancer

Retrieved on: 
Thursday, December 8, 2022
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CAPItello-291 is evaluating the efficacy of capivasertib in combination with FASLODEX versus placebo plus FASLODEX for the treatment of locally advanced (inoperable) or metastatic HR-positive, HER2-low or negative breast cancer.

Key Points: 
  • CAPItello-291 is evaluating the efficacy of capivasertib in combination with FASLODEX versus placebo plus FASLODEX for the treatment of locally advanced (inoperable) or metastatic HR-positive, HER2-low or negative breast cancer.
  • Capivasertib is an investigational oral treatment currently in Phase III trials for the treatment of multiple subtypes of breast cancer, prostate cancer and a Phase II trial for hematologic malignancies.
  • Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION).
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Blueprint Medicines Submits Supplemental New Drug Application to FDA for AYVAKIT® (avapritinib) for the Treatment of Indolent Systemic Mastocytosis

Retrieved on: 
Wednesday, November 23, 2022
European, Degenerative disease, End organ damage, Anaphylaxis, Lung cancer, Patent, Itch, Research, Marketing, Multimedia, Annual report, Smouldering, PDGFRA, BPMC, Patient, COVID-19, KIT, Quality of life, Cancer, GIST, Breast cancer, Mast cell leukemia, B cell, Brain, Safety, Diarrhea, Disease, Security (finance), AAAAI, SM, American Academy, ASM, Food, 2021 Essex County Council election, Mutation, Risk, FDA, Trial of the century, Bone pain, MCL, Fatigue, Medicine, Pharmaceutical industry, Mobile phone

CAMBRIDGE, Mass., Nov. 22, 2022 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration (FDA) for AYVAKIT® (avapritinib) for the treatment of adults with indolent systemic mastocytosis (SM). AYVAKIT was designed to potently and selectively inhibit D816V mutant KIT, the underlying cause of SM in about 95 percent of cases.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 22, 2022 /PRNewswire/ --Blueprint Medicines Corporation(NASDAQ:BPMC) today announced the submission of a supplemental new drug application to theU.S.
  • Food and Drug Administration(FDA) for AYVAKIT (avapritinib) for the treatment of adults with indolent systemic mastocytosis (SM).
  • The FDA has granted breakthrough therapy designation to AYVAKIT for the treatment of moderate to severe indolent SM.
  • Blueprint Medicines, AYVAKIT, AYVAKYTand associated logos are trademarks ofBlueprint Medicines Corporation.

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.

BeyondSpring Presents New Clinical Evidence of Plinabulin Protection of Granulocyte-Monocyte Progenitor Stem Cells for the Prevention of Chemotherapy-Induced Neutropenia at the ESMO Congress 2022

Retrieved on: 
Tuesday, September 13, 2022
Safety, Â, Multiple myeloma, NSCLC, Neutropenia, U.S. Securities and Exchange Commission, SCLC, Knowledge, HSPC, MM, Company, MOA, Therapy, Docetaxel, Forward-looking statement, Survival, Program, Patient, CIN, G-CSF, Research, Overalls, Squamous cell carcinoma, Bone pain, Form 20-F, Cancer, B cell, EGFR, APC, Pharmaceutical industry, Vaccine

Plinabulin is a unique novel agent with both CIN prevention and anti-cancer properties.

Key Points: 
  • Plinabulin is a unique novel agent with both CIN prevention and anti-cancer properties.
  • Plinabulin has single agent anti-cancer activity in a number of cancers including small cell lung cancer (SCLC) and multiple myeloma (MM).
  • Plinabulin also exerts early-onset of action in the prevention of chemotherapy-induced neutropenia (CIN) by boosting the number of hematopoietic stem/progenitor cells (HSPCs).
  • The plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data in the PROTECTIVE-2 study.

Kyowa Kirin Receives European Commission Approval for Use of CRYSVITA®▼(burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)

Retrieved on: 
Friday, August 19, 2022
Biotechnology, Pharmaceutical, Oncology, Health, Marketing, Communications, Clinical Trials, Other Health, Bone pain, EC, Research, FGF23, Osteology, Pain, Life, Department, XLH, Patient, Muscle weakness, Engineering, Neurology, Kyowa Hakko Kirin, TSE, TIO, NASDAQ, Nephrology, Bone disease, Walking, Royal commission, Burosumab, European Commission, University Medical Center Hamburg-Eppendorf, Vaccine, Pharmaceutical industry, Medical device, Hypophosphatemia, EU, Ultragenyx

This is a momentous day for the TIO community in Europe and Im proud that Kyowa Kirin can be a part of meeting the needs of people who have such a high unmet need, said Abdul Mullick, President of Kyowa Kirin International.

Key Points: 
  • This is a momentous day for the TIO community in Europe and Im proud that Kyowa Kirin can be a part of meeting the needs of people who have such a high unmet need, said Abdul Mullick, President of Kyowa Kirin International.
  • With this EC approval, Kyowa Kirin International will work with local health authorities in each country under the purview of the EC to ensure that those living with TIO are able to gain access to CRYSVITA as soon as possible.
  • Kyowa Kirin strives to create and deliver novel medicines with life-changing value.
  • You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/

Unicycive Reports Key Findings from Independent Renal Dietitian Survey

Retrieved on: 
Tuesday, July 26, 2022
Renal osteodystrophy, Osteoporosis, ESRD, Diabetes, Absorption, Kidney disease, Kidney, GLOBE, CKD, Intelligence, Mortality, Acute kidney injury, Dialysis, Cardiovascular disease, Fracture, Compliance, Hyperphosphatemia, Bone pain, Atherosclerosis, Chronic kidney disease, Risk, Therapy, SHPT, Biotechnology, Artery, Company, Gastrointestinal tract, Patient, Nasdaq, Bone disease, Hypertension, Pharmacotherapy, LOS, Lanthanum carbonate, Pharmaceutical industry, Rastogi

LOS ALTOS, Calif., July 26, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the results from an independent survey of renal dietitians conducted by Spherix Global Insights, an independent business intelligence firm that leverages its own independent data and expertise to provide strategic guidance. The survey canvassed 100 U.S. renal dietitians regarding a variety of topics related to the treatment of their chronic kidney disease and dialysis patients.

Key Points: 
  • The survey canvassed 100 U.S. renal dietitians regarding a variety of topics related to the treatment of their chronic kidney disease and dialysis patients.
  • Key findings from the Spherix survey:
    As renal dietitians indicate they have high influence on brand selection for phosphate binders, the results of this survey are an important barometer that further support the potential for Renazorb to be the phosphate binder of choice, said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive.
  • The Unicycive team is preparing to capitalize on this substantial opportunity by offering patients and providers an attractive treatment alternative.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

First Patient Dosed in CANbridge Pharmaceuticals CAN103 Phase 1/2 Trial for the Treatment of Gaucher Disease in China

Retrieved on: 
Thursday, July 21, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Glycogen storage disease type II, University of Washington School of Medicine, Death, ERT, Degenerative disease, Treatment, III, University, GBA, Glioblastoma, WuXi Biologics, Doctor of Philosophy, CEO, Haemophilia, Research, Fracture, Gaucher, Partnership, Bone pain, Peking Union Medical College Hospital, Safety, Gaucher's disease, University of Massachusetts, Glycogen storage disease, Cell, Quality of life, Hematology, Clinical trial, GD, Lysosomal storage disease, Disease, Hepatomegaly, Splenomegaly, Patient, Pharmacokinetics, Hunter syndrome, Department, Frost & Sullivan, Thrombocytopenia, Anemia, Diagnosis, Lysosome, Lists of diseases, Population, Enzyme replacement therapy, Pharmaceutical industry

CANbridge Pharmaceuticals Inc. (HKEX:1228), a China and US-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, announced that the first patient has been dosed in the CAN103 Phase 1/2 trial in treatment-nave patients with Gaucher disease (GD) Types I and III in China.

Key Points: 
  • CANbridge Pharmaceuticals Inc. (HKEX:1228), a China and US-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, announced that the first patient has been dosed in the CAN103 Phase 1/2 trial in treatment-nave patients with Gaucher disease (GD) Types I and III in China.
  • CAN103 is an enzyme replacement therapy (ERT) under development by CANbridge, as part of its rare disease partnership with WuXi Biologics (2269.HK), for the long-term treatment of adults and children with Gaucher disease Types I and III.
  • Part A (Phase 1) is an open-label study to evaluate the safety, tolerability and pharmacokinetics of different dose levels of CAN103 ERT in a small number of treatment-nave subjects with Gaucher disease Type I.
  • Dosing the first patient in the CAN103 Gaucher disease trial demonstrates the CANbridge commitment to developing rare disease solutions.

Unicycive Reports Key Findings from Market Research with Nephrologists

Retrieved on: 
Wednesday, July 20, 2022
Renal osteodystrophy, Osteoporosis, ESRD, Diabetes, Trademark, Absorption, Kidney disease, Kidney, GLOBE, CKD, Mortality, Acute kidney injury, U.S. Securities and Exchange Commission, Dialysis, Calcium, Research, Fracture, Cardiovascular disease, Compliance, Hyperphosphatemia, Bone pain, Private Securities Litigation Reform Act, Chronic kidney disease, Atherosclerosis, Risk, Failure, Therapy, Safety, COVID-19, Strategic management, SHPT, Nephrology, Biotechnology, Artery, MBA, FDA, Company, Security (finance), Gastrointestinal tract, Patient, Nasdaq, Bone disease, Coronavirus, Hypertension, Sevelamer, Face, LLC, Pharmacotherapy, LOS, Lanthanum carbonate, Pharmaceutical industry, Genzyme, Rastogi

LOS ALTOS, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the results from a primary market research study conducted on behalf of the company by Reason Research, LLC. The study was a discrete-choice model (“conjoint”) analysis in which 100 US-based nephrologists were presented with various phosphate binder attributes, including efficacy, safety/tolerability, pill burden, composition (calcium or non-calcium based), and dose form (chewable or swallowed), in a trade-off methodology to determine comparative prescribing preferences for currently available phosphate binders and Renazorb®, Unicycive’s product under development.

Key Points: 
  • Key findings from the research:
    Nephrologists estimate that they will prescribe Renazorb (pending FDA approval) for a market-leading 34% of their dialysis patients requiring phosphate binder therapy.
  • This market research with nephrologists, the predominant prescribers of phosphate binders, provides strong validation for our belief in the best-in-class potential of the Renazorb product profile, said Doug Jermasek, MBA, Executive Vice President, Corporate Strategy at Unicycive.
  • These survey results give us further confidence in the significant market opportunity for Renazorb.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

Unicycive Announces Exclusive License and Development Agreement with Lee’s Pharmaceutical Holdings Limited for Renazorb in China and Certain Other Asian Markets

Retrieved on: 
Monday, July 18, 2022
Dermatology, SEHK, Serum, Failure, Artery, Kidney disease, Diabetes, LOS, Company, ESRD, Coronavirus, Hyperphosphatemia, Compliance, Absorption, CKD, Pharming, Atherosclerosis, Renal osteodystrophy, Nasdaq, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, Medication, Incidence, Fracture, Physician, Mortality, Health, Pediatrics, Bone pain, PMP, Patient, Security (finance), Hypertension, Safety, Gastrointestinal tract, Bone disease, Kidney, CI, SHPT, COVID-19, Risk, Prevalence, Therapy, Achievement, Cardiovascular disease, Osteoporosis, Dialysis, GLOBE, Obstetrics, Acute kidney injury, Marketing, Drug development, Biotechnology, Degenerative disease, FDA, Chronic kidney disease, Pharmaceutical industry

LOS ALTOS, Calif., July 18, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that the Company has entered into an agreement granting exclusive rights to develop, market and commercialize Renazorb® (lanthanum dioxycarbonate) to Lee's Pharmaceutical (HK) Limited, a wholly-owned subsidiary of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”) (SEHK: 950), in Mainland China, Hong Kong, and certain other Asian markets. Renazorb is Unicycive’s novel phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients.

Key Points: 
  • Renazorb is Unicycives novel phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients.
  • Unicycive owns global rights for Renazorb and by partnering Renazorb in select Asian countries, we begin to unlock its value for patients, physicians and for our shareholders.
  • Under the terms of the agreement, Lee Pharm will be responsible for development, registration filing and approval for Renazorb in the licensed territories.
  • Renazorb also provides Lees Pharms commercial team with another product in our portfolio to sell in Asian markets.

1 in 50 Women Will Suffer From Parathyroid Disease

Retrieved on: 
Wednesday, July 6, 2022
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Hyperparathyroidism (parathyroid disease) is the most common condition of parathyroid glands, caused by the development of a tumor on one or more parathyroid glands.

Key Points: 
  • Hyperparathyroidism (parathyroid disease) is the most common condition of parathyroid glands, caused by the development of a tumor on one or more parathyroid glands.
  • In fact, the Norman Parathyroid Center cites that 1 in 50 women will suffer from parathyroid disease at some point in their lives.
  • The surgeons at the Norman Parathyroid Center are by far the most experienced parathyroid surgeons in the world performing 70+ parathyroid operations per week.
  • Located in Tampa, Florida, the Norman Parathyroid Center is the leading parathyroid gland tumor treatment center in the world, performing nearly 3,800 parathyroid operations annually.