CYP3A4

Chiesi Global Rare Diseases Showcases Ongoing Commitment to Multiple Rare Diseases Communities at ENDO 2024 Meeting Debut

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金曜日, 6月 14, 2024
ENDO, Incidence, Vomiting, Post hoc analysis, Patient, Insulin, OOC, Pregnancy, MACRO, Swelling, Weakness, Digoxin, Indigestion, Antacid, Arthralgia, Gallstone, Headache, Hypersensitivity, Lisinopril, LDS, Endocrine disease, Blood, Ciclosporin, Calcium channel, Bromocriptine, Arrhythmia, Anaphylaxis, Woman, Somatostatin, Bradycardia, AIS, Hyperhidrosis, Chronic pain, Octreotide, Clinical Global Impression, Chiesi Farmaceutici, Safety, Lipodystrophy, Common, Endocrine system, Gallbladder, Osteoarthritis, Nausea, Diarrhea, CYP3A4, Birth, Enzyme inhibitor, Sinusitis, FDA, CGI, Pharmaceutical industry

BOSTON, June 14, 2024 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced updates from their rare endocrine disease portfolio with two late-breaking poster presentations and one oral presentation during the Endocrine Society’s ENDO 2024 Meeting that was held June 1-4, 2024, in Boston, Massachusetts. Presentations included a post hoc analysis of three Phase 3 clinical trials (CH-ACM-01, OPTIMAL, MPOWERED) studying MYCAPSSA (octreotide) as well as real-world MYCAPSSA use data from the Chiesi Management of Acromegaly (MACRO) registry and presentation of the Lipodystrophy Severity Scoring tool designed to assess the disease burden of lipodystrophy.

Key Points: 
  • "We're thrilled to support this community of people living with burdensome rare endocrine diseases through the innovation of new resources and validated medicines to aid in disease management," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases.
  • Median decrease of one symptom per patient and a mean decrease of 0.8 in Acromegaly Index of Severity (AIS) further underscored symptom improvement.
  • The mean time on OOC was 19.7 months, with the majority receiving treatment for at least 6 months.
  • Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary Cholangitis

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月曜日, 6月 10, 2024
Steroid, Myalgia, Acute kidney injury, Birth, Pregnancy, Patient, Alkaline phosphatase, Drug discovery, Tablet, CPK, ACLF, Milk, Hypersensitivity, Rhabdomyolysis, U.S. FDA, PBC, Allergy, Rash, Hepatic encephalopathy, Fracture, Effectiveness, UDCA, Myopathy, Reproductive system, Clinical trial, Interrupt, Bile, Bilirubin, Survival, Sale, Food, Partnership, Eosinophilia, Primary biliary cholangitis, IPN, Fetus, ADR, Rifampicin, Cirrhosis, Bleeding, ALP, TB, HMG-CoA, Ursodeoxycholic acid, Infant, Hepatology, Enzyme, Ascites, Risk, Lactation, CYP3A4, Miscarriage, FDA, Jaundice, ALT, Pharmaceutical industry

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP).

Key Points: 
  • This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP).
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Iqirvo is not recommended for people who have or who develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
  • Pascal Prigent, CEO of GENFIT, commented: “This approval is a source of pride for all GENFIT employees.

Syndax Presents Updated Positive Data from BEAT AML and AUGMENT-102 Phase 1/2 Combination Trials of Revumenib in Patients with Acute Leukemias at EHA 2024 Congress

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金曜日, 6月 14, 2024
Congress, Leukemia, Postcholecystectomy syndrome, SNDX, Patient, EHA, QT interval, Transplant, HSCT, BEAT, European Hematology Association, MRD, University of North Carolina, Platelet, Sepsis, CYP3A4, DS, Acute myeloid leukemia, Febrile neutropenia, CRC, NPM1, Aes, Anemia, Death, DLT, Cytopenia, AML, Ageing, Acute leukemia, Pharmaceutical industry

WALTHAM, Mass., June 14, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated data from multiple combination trials of revumenib, the Company's potent, selective, small molecule menin inhibitor, in patients with acute leukemias. The updated data are being presented at the European Hematology Association (EHA) 2024 Congress, being held June 13-16 in Madrid, Spain and virtually.

Key Points: 
  • The updated data are being presented at the European Hematology Association (EHA) 2024 Congress, being held June 13-16 in Madrid, Spain and virtually.
  • "We are committed to advancing revumenib across a spectrum of acute leukemia patients.
  • As of the data cutoff date of May 1, 2024, 26 newly diagnosed mNPM1 (n=17) or KMT2Ar (n=9) AML patients were enrolled.
  • Revumenib was dosed safely at both the 113 mg and 163 mg q12h dose in combination with venetoclax and azacitidine.

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

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月曜日, 4月 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

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月曜日, 4月 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

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月曜日, 2月 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

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火曜日, 1月 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

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火曜日, 1月 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

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火曜日, 12月 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

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木曜日, 11月 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.