QT interval

AstraZeneca caps patient out-of-pocket costs at $35 per month for its US inhaled respiratory portfolio

Retrieved on: 
Monday, March 18, 2024
Biotechnology, Medical Devices, Health, Pharmaceutical, Health Insurance, Diabetes, Blood pressure, Depression, Arrhythmia, Hypokalemia, ICS, Anaphylaxis, Angioedema, Congress, Moyamoya disease, AstraZeneca, MAOI, Hyperthyroidism, Risk, ECG, Incidence, Headache, Immunosuppression, Patient, QT interval, Chronic obstructive pulmonary disease, Inhalation, Chickenpox, Research, Budesonide, System, Liver, Cough, Rash, Infection, Salbutamol, Water, Cataract, Adrenal gland, Measles, Safety, Bronchospasm, COPD, Glaucoma, Use, Catherine Disher, Fatality, Monoamine oxidase inhibitor, Hypertension, Medicine, Pharmaceutical industry

AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.

Key Points: 
  • AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.
  • We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone.
  • The Company will continue to provide discounts and rebates off the list price to help patients afford its inhaled respiratory medicines.
  • AstraZeneca remains dedicated to transforming patient outcomes, while ensuring access and affordability of our innovative medicines.

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, March 21, 2024
Research, HDAC, Neurological disorder, Walking, Abdominal pain, Dietary supplement, Risk, Inflammation, Patient, QT interval, Public, Animal, Duchenne muscular dystrophy, Diarrhea, Food, Human services, Platelet, Facial muscles, Life expectancy, Heated tobacco product, Fever, Atrophy, Safety, Division, NSAA, Muscle weakness, Cosmetics, Vaccine, Multimedia, FDA, DMD, Muscular dystrophy, Triglyceride, Pharmaceutical industry

SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.

Key Points: 
  • SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.
  • Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.
  • "This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation."
  • DMD is the most common childhood form of muscular dystrophy and typically affects males.

Kura Oncology Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
NSCLC, Leukemia, Research, AML, Pedal, QT interval, FTI, Mirati Therapeutics, Investment, Postcholecystectomy syndrome, Physician, Clinical trial, ID, HRAS, Mirati, Prognosis, Renal cell carcinoma, FLT3, Webcast, Patient, KURA, Disease, G&A, LDAC, HNSCC, Cancer, Pharmaceutical industry

ET –

Key Points: 
  • ET –
    SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported fourth quarter and full year 2023 financial results and provided a corporate update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $32.5 million, compared to $22.7 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $14.2 million, compared to $12.5 million for the fourth quarter of 2022.
  • ET / 1:30 p.m. PT today, February 27, 2024, to discuss the financial results for the fourth quarter and full year 2023 and to provide a corporate update.

TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

Retrieved on: 
Monday, February 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, NSCLC, Fever, Progression-free survival, PFS, AstraZeneca, Heart, Periodic breathing, QT interval, MD, Chemoradiotherapy, Cough, Pemetrexed, Winship Cancer Institute, QT, OS, Electrolyte, Cardiomyopathy, Lung cancer, Safety, Emory University, CRT, LAURA, ILD, Patient, LVEF, Brain, Pharmaceutical industry

In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.

Key Points: 
  • In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.
  • Interstitial lung disease (ILD)/pneumonitis occurred in 4% of the 1813 TAGRISSO-treated patients; 0.4% of cases were fatal.
  • TAGRISSO is the only targeted therapy to improve patient outcomes in both early-stage disease in the ADAURA Phase III trial and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial .
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

TAGRISSO® (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

Retrieved on: 
Saturday, February 17, 2024
Oncology, FDA, Health, General Health, Pharmaceutical, Biotechnology, Heart, QT interval, Food, Pemetrexed, Risk, Cardiomyopathy, Electrolyte, Death, Patient, LVEF, Priority review, Pharmaceutical industry

This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.

Key Points: 
  • This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.
  • The safety profile of TAGRISSO with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines.
  • Adverse event (AE) rates were higher in the TAGRISSO plus chemotherapy arm, driven by well-characterized chemotherapy-related AEs.
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

Kura Oncology Reports Positive Preliminary Ziftomenib Combination Data in Acute Myeloid Leukemia

Retrieved on: 
Tuesday, January 30, 2024
KURA, Failure, Acute myeloid leukemia, Venetoclax, Research, Division, MHS, Patient, Safety, QT interval, AML, Bone marrow, MBBS, QD, Yale Cancer Center, Disease, Therapy, Postcholecystectomy syndrome, Risk, ID, Cancer, Kura, Pharmaceutical industry

Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.

Key Points: 
  • Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.
  • The overall response rate (ORR) among R/R patients treated with ziftomenib and ven/aza was 53% (8/15).
  • As of the data cutoff, 80% (16/20) of patients remain on trial, including 100% (11/11) of all NPM1-m patients.
  • “We are highly encouraged by these preliminary combination data for ziftomenib and believe they support advancement into the frontline AML population,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology.

Xspray Pharma’s XS003 Achieves Superior Bioavailability Milestone, Matching TASIGNA® at Reduced Dosage

Retrieved on: 
Tuesday, November 21, 2023
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, NDA, Risk, Doctor of Philosophy, QT interval, Absorption, PKI, Sudden death, Pharmaceutical industry

This is the second of three announced amorphous PKIs under development by Xspray using the HyNap platform to address critical limitations with currently marketed crystalline formulations.

Key Points: 
  • This is the second of three announced amorphous PKIs under development by Xspray using the HyNap platform to address critical limitations with currently marketed crystalline formulations.
  • “Our goal is to submit the NDA to the FDA in the second half of 2024 once all required studies are finalized; such as e.g.
  • food effect and proton pump inhibitor interaction,” says Xspray Pharma Chief Executive Officer, Per Andersson, PhD.
  • We have now demonstrated that XS003 exhibits improved absorption, matching TASIGNA at lower dose.”

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.

Clario's Oncology Webinar Series Part 3 -- Integrating Objectively Measured Safety Endpoints and Patient-Reported Outcomes in Oncology Trials: A Scientific Approach

Retrieved on: 
Wednesday, November 22, 2023
Safety, Patient safety, Consultant, Science, Pros, Medicine, Part, FDA, CVI, QT interval, MD, EST, Doctor of Philosophy, Oncology, Knowledge, Outline, Circulation: Cardiovascular Imaging, Drug development, Blood pressure, Nursing, Medical imaging, Clario Tech, Cardiology

TORONTO, Nov. 22, 2023 /PRNewswire-PRWeb/ -- In the ever-evolving landscape of drug development within oncology, the importance of collecting high-quality data across multiple endpoints cannot be overstated. This data plays a pivotal role in determining the success of a drug. The integration of objective safety measurements with patient-reported outcomes is now essential in characterizing a drug's safety profile, influencing overall benefit-risk considerations. Through this webinar, Clario invites you to explore our comprehensive scientific approach to enhancing safety and tolerability assessments in oncology trials.

Key Points: 
  • In this free webinar, Part 3 of Clario's Oncology Webinar Series, learn about a scientific approach to enhancing safety and tolerability assessments in oncology trials.
  • The integration of objective safety measurements with patient-reported outcomes is now essential in characterizing a drug's safety profile, influencing overall benefit-risk considerations.
  • Through this webinar, Clario invites you to explore our comprehensive scientific approach to enhancing safety and tolerability assessments in oncology trials.
  • For more information, or to register for this event, visit Clario's Oncology Webinar Series .

VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Thursday, November 9, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, QT interval, Cardiac arrest, National Center for Health Research, Acute myeloid leukemia, ECG, European Commission, Hypokalemia, Committee, European Directive on Traditional Herbal Medicinal Products, Febrile neutropenia, MD, Professor, News, University Hospital Heidelberg, EC, Maintenance, Pneumonia, Arrhythmia, Ventricular fibrillation, ALAN, Civil service commission, Daiichi Sankyo, Risk, TSE, HR, Leukemia, FLT3, Committee for Medicinal Products for Human Use, Safety, German Cancer Research Center, European, Patient, Death, Neutropenia, AML, Nursing, Pharmaceutical industry, EU, Lancet

VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2

Key Points: 
  • VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2
    The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet .
  • The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%).
  • QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation.
  • Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.