CYP3A4

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide

Retrieved on: 
Monday, February 26, 2024
DRUG, Syncope, Suicidal ideation, Headache, Hypersensitivity, FDA, Eosinophilia, Dizziness, CYP3A4, Anticonvulsant, Disulfiram-like drug, Pharmacy, Suicide, Seizure, Nausea, CYP2C9, Risk, Diplopia, Ataxia, Ideation, Patient, Somnolence, DRESS, Depression, Pharmaceutical industry

MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.

Key Points: 
  • MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
  • MOTPOLY XR is bioequivalent to Vimpat® (lacosamide) film-coated tablets, C-V and provides a new once-daily option at equivalent doses.
  • "MOTPOLY XR marks a major milestone for Aucta as our 1st branded pharmaceutical product to enter the US market.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Court Finds Corcept Therapeutics’ Patents Not Infringed

Retrieved on: 
Tuesday, January 2, 2024
FDA, CYP3A4, Patient, Metabolism, Teva Pharmaceuticals, MD, Pharmaceutical industry

Patents 10,195,214 and 10,842,800, both of which concern methods of safely administering Korlym® with drugs that are strong CYP3A4 inhibitors.

Key Points: 
  • Patents 10,195,214 and 10,842,800, both of which concern methods of safely administering Korlym® with drugs that are strong CYP3A4 inhibitors.
  • “This disappointing decision is based on legal and factual errors we are confident will be reversed on appeal,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.
  • “Our patents describe medical discoveries that have greatly expanded the therapeutic options available to patients suffering from Cushing’s syndrome, which is why the FDA added them to Korlym’s prescribing instructions.
  • Doctors have followed these instructions and will continue to do so to safely treat patients.

Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Liver, Medical Subject Headings, Fungal infection, Marketing, European Commission, INN, Stomach, Allergy, Itraconazole, Saquinavir, ATC, Glass, Nelfinavir, Depression, Kidney disease, Bleeding, International, European, Megacolon, Disease, Urinary retention, Language, Muscle weakness, Urinary bladder, Inflammation, Nefazodone, Water, Peanut, Ulcerative colitis, Colitis, Ketoconazole, Ritonavir, Tablet, Hyperkinesia, Indinavir, CYP3A4, Xerostomia, Select, Committee, Urination, Patient, Liver disease, Atazanavir, Anatomy, Medicine, Clarithromycin, IIA, CHMP, Medical device

Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Syndax Presents Positive Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at Late-Breaking Oral Presentation During 65th ASH Annual Meeting

Retrieved on: 
Tuesday, December 12, 2023
Data, Principal, Trae Waynes, Pivotal, Associate professor, Food, Postcholecystectomy syndrome, Transplant, City, HSCT, Acute myeloid leukemia, ASH, Cytopenia, DS, Haematopoietic system, Publication, MRD, Division, QT interval, CRC, CRH, SNDX, CYP3A4, Acute leukemia, Nausea, ORR, 65th Armoured Regiment (India), AML, Society, Female, Poster, ALL, Safety, Vaccine, Pharmaceutical industry, Nursing, Leukemia, Hematology, Patient

The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."

Key Points: 
  • The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."
  • Minimal residual disease (MRD) status was assessed in 10 of the 13 patients who achieved a CR/CRh, 70% (7/10) of whom were MRD negative.
  • In adults with AML (n=51), the CR/CRh rate was 37.3% and ORR was 68.6%, with 40% of responders proceeding to HSCT.
  • Copies of the ASH presentations are available in the Publications and Meeting Presentations section of Syndax's website.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

Retrieved on: 
Thursday, November 2, 2023
Trae tha Truth, ECOG, Vomiting, CYP3A4, WT, Abstract, NPM1, KMT2A, OBD, PK, DLT, TKD, Cancer, Diabetes, ORR, Clinical study design, Safety, Patient, Cohort, HSCT, SETBP1, CR, DSM-IV codes, NUP214, DOR, Dicarboxylic acid, CRi, ASH, CD135, QT interval, RFS, FLT3, Arm, Cellular, FMS, Transplant, ALL, Toxic leukoencephalopathy, Gene family, Survival, Postcholecystectomy syndrome, DS, Trial of the century, Incidence, CRC, Infrared spectroscopy correlation table, AL, Osteopathic medicine in Canada, MN1, BID, CNS, KRAS, ATD, NUP98, Society, WBC, Pharmacokinetics, CLL, Acute leukemia, Common, ITD, Toxicity, AML, Cardiovascular disease, Pharmaceutical industry, Dentistry, Vaccine, Decitabine, DLBCL

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Endo Launches Colchicine Capsules, Generic Version of MITIGARE®

Retrieved on: 
Thursday, November 2, 2023
Aplastic anemia, Patient, Abdominal pain, Clarithromycin, Food, Fatal, Thrombocytopenia, Vomiting, Diarrhea, OTC, Colchicine, Endo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nausea, Bone marrow suppression, Endo International, Senior, Ciclosporin, Rhabdomyolysis, Risk, Capsule, Leukopenia, Pancytopenia, Safety, Pain, Granulocyte, Death, Pharmaceutical industry, Dairy, Dietary supplement, CYP3A4

DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.

Key Points: 
  • DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.
  • This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.
  • Patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors.
  • Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Endo Launches Colchicine Capsules, Generic Version of MITIGARE®

Retrieved on: 
Thursday, November 2, 2023
Aplastic anemia, Patient, Abdominal pain, Clarithromycin, Food, Fatal, Thrombocytopenia, Vomiting, Diarrhea, OTC, Colchicine, Endo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nausea, Bone marrow suppression, Endo International, Senior, Ciclosporin, Rhabdomyolysis, Risk, Capsule, Leukopenia, Pancytopenia, Safety, Pain, Granulocyte, Death, Pharmaceutical industry, Dairy, Dietary supplement, CYP3A4

DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.

Key Points: 
  • DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.
  • This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.
  • Patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors.
  • Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, October 19, 2023
Kidney, Pregnancy, Adrenal insufficiency, Biomarker, EGFR, Vaccine, Glaucoma, Budesonide, American Society of Nephrology, Diabetes, Infection, Ritonavir, CYP3A4, Ciclosporin, Disease, Risk, Capsule, Itraconazole, UPCR, Parasitism, Hypersensitivity, Proteinuria, Alport syndrome, Saquinavir, Measles, Prediabetes, Miscarriage, Immune system, HPA, Ketoconazole, Fetus, CALT, Patient, Anaphylaxis, Tropical ulcer, IgA nephropathy, Indinavir, BAFF, Contraindication, Serum, Cataract, Birth, Administration, Society, Liver, Erythromycin, ASN, Hypertension, Osteoporosis, Immunoglobulin A, Drug interaction, Immunosuppression, Pharmaceutical industry, Dietary supplement, Alport

STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.

Key Points: 
  • STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.
  • Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas' corporate website following the meeting.
  • It has not been established whether TARPEYO slows kidney function decline in patients with IgAN.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.