Hypocalcemia

Sandoz receives FDA approval for first and only denosumab biosimilars

Retrieved on: 
Tuesday, March 5, 2024
Bone fracture, Fracture, Woman, Hypocalcemia, Osteoporosis, Bone disease, Hypercalcaemia, FDA, Quality of life, Food, Cancer, Denosumab, Metastasis, Risk, Breast, Safety, Mitigation, Novartis, REMS, Benign tumor, Disease, Patent, Patient, Medicine, Multiple myeloma, Ageing, Dietary supplement

Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.

Key Points: 
  • Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.
  • I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."
  • Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
  • Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time.

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Tuesday, February 13, 2024
Urinary tract infection, Gastroesophageal reflux disease, Research, Heartburn, Toxicity, Magnesium, Polyp, Liver, CYP, CGA, Achlorhydria, Esophagitis, Patient, PBM, Vitamin B12, Vonoprazan, Kidney, Spine, Lactation, Absorption, Hypokalemia, SCAR, Calcium, Express Scripts, TIN, Endoscopy, Tablet, Express, Magnesium deficiency, Hypocalcemia, Diarrhea, Hypersensitivity, Physician, Gastritis, Malabsorption, GERD, PPI, Hypertension, SJS, Enzyme inhibitor, EGFR, Stevens–Johnson syndrome, Indigestion, Nelfinavir, Clostridioides, Abdominal pain, Hip, Pharmacy, Enzyme, Glomus tumor, FDA, CDAD, Atazanavir, Risk, BMJ Open, Wrist, Drug, Impairment, Pharmaceutical industry

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024
Fungal infection, Liver, Marketing, Chills, INN, Risk, Leukopenia, Hypotension, Fungus, Hypertension, Nausea, DNA, Inflammation, Liver disease, Anatomy, IIA, CHMP, Diarrhea, Fever, Infection, ATC, Hepatomegaly, European, Neutrophil, Neoplasm, HIV, Tachycardia, Anemia, Hypocalcemia, Hypokalemia, Patient, Medical Subject Headings, Caspofungin, European Commission, Echinocandin, Kidney failure, International, Bilirubin, Neutropenia, Blood, Language, Thrombocytopenia, Magnesium, Select, Medicine, Vomiting, Phlebitis, Amphotericin B, Allergy, Fluconazole, Headache, Rat, Haematopoiesis, Committee, Checklist, Alkaline phosphatase, Rash, Medical device

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
People, Marketing, INN, Risk, Leukopenia, Hypophosphatemia, Hypotension, Pneumonia, Potassium, Nausea, Cancer, Myenteric plexus, Infection, Anatomy, Cough, IIA, Multiple myeloma, Chills, Consciousness, Diarrhea, Fever, Fatigue, Bone marrow, ATC, Pharyngitis, Pain, Platelet, Disease, Nose, Edema, Neutrophil, Speech, Depression, Appetite, Writing, Lymphocyte, Safety, Water, Tachycardia, Anemia, Neurological disorder, Hypocalcemia, Sepsis, Hypokalemia, Patient, Medical Subject Headings, Febrile neutropenia, Lymphocytopenia, Cytokine release syndrome, International, Encephalopathy, Neutropenia, Blood, Language, Thrombocytopenia, Neurotoxicity, Select, Medicine, Vomiting, Upper respiratory tract infection, Headache, Hospital, BCMA, Confusion, European Medicines Agency, Cell, Medical device

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Phathom Pharmaceuticals Announces FDA Acceptance for Filing of VOQUEZNA® (vonoprazan) Tablets New Drug Application for the Treatment of Heartburn Associated with Non-Erosive GERD

Retrieved on: 
Wednesday, December 6, 2023
Quality of life, CYP, Kidney, Risk, Heartburn, Enzyme inhibitor, FDA, TIN, Hypertension, Achlorhydria, Magnesium, Liver, PPI, SJS, Magnesium deficiency, Chest pain, Atazanavir, Endoscopy, Impairment, SCAR, Vitamin B12, Malabsorption, Absorption, PDUFA, CDAD, Calcium, New Drug Application, Gastritis, Enzyme, Food and Drug Administration, Clostridioides, Vonoprazan, Patient, Hip, Hypokalemia, Food, Polyp, GERD, Nelfinavir, Toxicity, EGFR, Wrist, Diarrhea, Hypocalcemia, NDA, Abdominal pain, Urinary tract infection, Hypersensitivity, Stevens–Johnson syndrome, Glomus tumor, Spine, Indigestion, Drug, CGA, Lactation, Pharmaceutical industry

The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.

Key Points: 
  • The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
  • “Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals and impacting their quality of life.
  • Symptoms impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.

Medefil Announces Availability of FDA-Approved Emergency Syringes, Atropine Sulfate Injection, USP, and 10% Calcium Chloride Injection, USP

Retrieved on: 
Monday, December 4, 2023
Other Manufacturing, Medical Devices, Medical Supplies, FDA, Manufacturing, Managed Care, Health, Pharmaceutical, General Health, Calcium chloride, Plasma, Hypocalcemia, ANDA, USP, Pharmaceutical industry, Phosphorus

Medefil, Inc., a domestic manufacturer of injectable products, has announced availability of its FDA-approved ANDA products, Atropine Sulfate Injection, USP, 1 mg per 10 mL (0.1 mg/mL), and 10% Calcium Chloride Injection, USP, 1000 mg per 10 mL (100 mg/mL).

Key Points: 
  • Medefil, Inc., a domestic manufacturer of injectable products, has announced availability of its FDA-approved ANDA products, Atropine Sulfate Injection, USP, 1 mg per 10 mL (0.1 mg/mL), and 10% Calcium Chloride Injection, USP, 1000 mg per 10 mL (100 mg/mL).
  • These products are currently listed on the FDA drug shortage list and are available immediately for purchase from Medefil through national wholesalers.
  • Atropine Sulfate Injection, USP, is used for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
  • 10% Calcium Chloride Injection, USP is used for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.

American Regent Introduces Potassium Phosphates, USP; FDA-Approved and "AP" Rated¹

Retrieved on: 
Thursday, October 19, 2023
Cardiac arrest, ECG, Injection, Seizure, Arrhythmia, Nephrocalcinosis, Hypercalcaemia, Infant, Kidney, Continuity, Risk, Hyperkalemia, Death, Parenteral nutrition, Child, Potassium, Lactation, Thrombosis, Acute kidney injury, Milk, Tetany, Toxicity, Phosphate, Patient, Central nervous system, Bolus, Hyperphosphatemia, Hypophosphatemia, Hypotension, Hypocalcemia, Tubing (recreation), Pulmonary embolism, Use, Aluminium, Administration, Late preterm infant, QT, Calcium, Ketoacidosis, Phosphorus, Birth control, Medical device, Pharmaceutical industry, Magnesium deficiency

In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death.

Key Points: 
  • In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death.
  • Vein Damage and Thrombosis: Potassium Phosphates Injection must be diluted and administered in intravenous fluids or used as an admixture in parenteral nutrition.
  • You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
  • You are encouraged to report adverse drug events (ADEs) to American Regent:
    ADEs may also be reported to the FDA:

Monte Rosa Therapeutics Announces Interim PK/PD and Clinical Data for MRT-2359 in Phase 1/2 Trial for MYC-Driven Solid Tumors

Retrieved on: 
Tuesday, October 17, 2023
Cancer, Glomus tumor, Telephone, Hypocalcemia, Treatment of lung cancer, NSCLC, Trial of the century, First grade, Aes, SCLC, Cytokine release syndrome, Safety, Interim, Conference call, MD Anderson Cancer Center, Associate professor, Therapy, SD, DLT, University, Webcast, MGD, CRS, Lung, PD, Principal investigator, Neoplasm, Optimism, Prostate, Hypotension, Conference, Patient, MYC, Vaccine, Pharmaceutical industry, Medical imaging, GSPT1

BOSTON, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced interim data from the Phase 1 dose escalation part of its ongoing Phase 1/2 open-label, multicenter study of MRT-2359 in patients with MYC-driven solid tumors, including lung cancers and high-grade neuroendocrine cancer. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered by Monte Rosa Therapeutics. Cancers driven by MYC overexpression have been demonstrated to be dependent on GSPT1, creating a therapeutic opportunity.

Key Points: 
  • MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered by Monte Rosa Therapeutics.
  • Interim clinical data from the MRT-2359 study have demonstrated favorable tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles in heavily pre-treated patients with lung cancers and high-grade neuroendocrine cancer.
  • Monte Rosa is continuing with dose level and schedule optimization in this ongoing study.
  • We continue to explore optimal doses and dosing schedules as we collect clinical data from this ongoing Phase 1/2 study," said Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics.

BridgeBio Pharma Announces New England Journal of Medicine Publication of Positive Encaleret Proof-of-Concept Phase 2b Results in Patients with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Retrieved on: 
Tuesday, October 10, 2023
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“Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.

Key Points: 
  • “Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.
  • But this burdensome regimen may also increase urine calcium levels above normal, which can damage the kidney, leading to kidney failure in worst-case scenarios.
  • People with ADH1 need better treatments, so they are not constantly walking on a tightrope.
  • As part of the Phase 2b study, participants completed one or two 5-day inpatient dose-ranging periods, followed by a 24-week outpatient period.