QT interval

Harmony Biosciences To Present WAKIX® (Pitolisant) Data At The 2021 AAN Annual Meeting

Retrieved on: 
Lunedì, Aprile 12, 2021

"We look forward to sharing these data and the results of these analyses with both the neurology and narcolepsy communities.

Key Points: 
  • "We look forward to sharing these data and the results of these analyses with both the neurology and narcolepsy communities.
  • "\nThe data that will be presented by Harmony will be available from 7 a.m.-5 p.m. EDT on April 17-22, and include:\nTime to Onset of Clinical Response During Treatment with Pitolisant (P26.015).
  • WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.\nWAKIX prolongs the QT interval.
  • Avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval.

Newron Announces Results of Explanatory Studies With Evenamide in Healthy Volunteers and Patients With Schizophrenia

Retrieved on: 
Giovedì, Aprile 1, 2021

These results strongly suggest that evenamide does not increase a patients risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.

Key Points: 
  • These results strongly suggest that evenamide does not increase a patients risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.
  • No patient on evenamide discontinued from the study due to adverse events, and there were no significant adverse events relating to evenamide.
  • There were no differences in laboratory, ECG or vital signs abnormalities between evenamide and placebo-treated patients.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

DGAP-News: Newron announces results of explanatory studies with evenamide in healthy volunteers and patients with schizophrenia

Retrieved on: 
Giovedì, Aprile 1, 2021

These results strongly suggest that evenamide does not increase a patient's risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.

Key Points: 
  • These results strongly suggest that evenamide does not increase a patient's risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.
  • No patient on evenamide discontinued from the study due to adverse events, and there were no significant adverse events relating to evenamide.
  • Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

TAGRISSO Granted Priority Review in the US for the Adjuvant Treatment of Patients With Early-stage EGFR-mutated Lung Cancer

Retrieved on: 
Martedì, Ottobre 20, 2020

Interstitial lung disease (ILD)/pneumonitis occurred in patients treated with TAGRISSO, some of which were fatal.

Key Points: 
  • Interstitial lung disease (ILD)/pneumonitis occurred in patients treated with TAGRISSO, some of which were fatal.
  • Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
    Cardiomyopathy occurred in TAGRISSO-treated patients, some of which were fatal.
  • Monitor patients with cardiac risk factors and assess left ventricular ejection fraction in patients who develop symptoms during treatment.
  • EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples.

Nabriva’s XENLETA Demonstrates High Efficacy in Patients of Advanced Age with Community-Acquired Bacterial Pneumonia (CABP)

Retrieved on: 
Martedì, Ottobre 13, 2020

Our post-hoc analysis highlights that XENLETA provides a safe and effective empiric monotherapy alternative to fluoroquinolones for treatment of CABP in patients with advanced age and comorbidities.

Key Points: 
  • Our post-hoc analysis highlights that XENLETA provides a safe and effective empiric monotherapy alternative to fluoroquinolones for treatment of CABP in patients with advanced age and comorbidities.
  • Compared to younger patients, patients 65 years of age and older had higher pneumonia severity scores and were more likely to have renal impairment, cardiac disease, hypertension, diabetes or asthma/COPD.
  • Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP.
  • Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

Apttus and Conga Combine to Become Leader in Digitally Transforming Commercial Operations

Retrieved on: 
Giovedì, Maggio 7, 2020

SAN MATEO, Calif., May 7, 2020 /PRNewswire/ --Apttus, the leader in quote-to-cash (QTC) solutions, and Conga, the leader in Digital Document Transformation today announced the two companies are joining forces to create the leader in digital transformation for commercial operations.

Key Points: 
  • SAN MATEO, Calif., May 7, 2020 /PRNewswire/ --Apttus, the leader in quote-to-cash (QTC) solutions, and Conga, the leader in Digital Document Transformation today announced the two companies are joining forces to create the leader in digital transformation for commercial operations.
  • Conga's end-to-end solution will empower organizations to revolutionize business operations, streamline workflows and deliver documents more effectively in the changing digital economy.
  • "Apttus and Conga are people-first businesses with core values that fit together seamlessly, and both are fueled by an inherent drive to succeed.
  • The company is privately-held and based in Broomfield, Colo. with global operations across North America, Europe and Australia.

Apttus and Conga Combine to Become Leader in Digitally Transforming Commercial Operations

Retrieved on: 
Giovedì, Maggio 7, 2020

Apttus, the leader in quote-to-cash (QTC) solutions, and Conga, the leader in Digital Document Transformation today announced the two companies are joining forces to create the leader in digital transformation for commercial operations.

Key Points: 
  • Apttus, the leader in quote-to-cash (QTC) solutions, and Conga, the leader in Digital Document Transformation today announced the two companies are joining forces to create the leader in digital transformation for commercial operations.
  • Congas end-to-end solution will empower organizations to revolutionize business operations, streamline workflows and deliver documents more effectively in the changing digital economy.
  • Apttus and Conga are people-first businesses with core values that fit together seamlessly, and both are fueled by an inherent drive to succeed.
  • The company is privately-held and based in Broomfield, Colo. with global operations across North America, Europe and Australia.

FDA Grants Emergency Use Authorization to VitalConnect for Cardiac Monitoring in COVID-19 Patients

Retrieved on: 
Martedì, Maggio 5, 2020

Under the FDA EUA, the VitalPatch is now authorized to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19.

Key Points: 
  • Under the FDA EUA, the VitalPatch is now authorized to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19.
  • This EUA status from the FDA comes at a crucial time when patients need access to continuous, real-time monitoring the most, and VitalConnect's unique vital sign and cardiac monitoring solution provides the information necessary to help save lives.
  • VitalConnect is a leader in wearable biosensor technology for wireless patient monitoring in both hospital and remote patient populations.
  • VitalConnect's products are designed for use in a broad range of inpatient and outpatient settings, such as hospital monitoring, post-discharge care, cardiac monitoring and pharmaceutical solutions.

XENLETA® (Lefamulin) Treatment Results in a Rapid Time-to-Clinical Response in Hospitalized Patients with Community-Acquired Bacterial Pneumonia (CABP)

Retrieved on: 
Martedì, Maggio 5, 2020

The analyses indicate that lefamulin results in a rapid and similar time to clinical response, a proxy for hospital discharge readiness, compared to moxifloxacin.

Key Points: 
  • The analyses indicate that lefamulin results in a rapid and similar time to clinical response, a proxy for hospital discharge readiness, compared to moxifloxacin.
  • In the treatment of hospitalized patients with CABP, length of stay is the primary driver of the cost of care, said Dr. Lodise.
  • XENLETA is a first-in-class pleuromutilin antibiotic approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia.
  • Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

Huntsman Accelerates Global Contract Lifecycle by 40% with Apttus

Retrieved on: 
Giovedì, Aprile 30, 2020

SAN MATEO, Calif., April 30, 2020 /PRNewswire/ -- Apttus , the Middle Office leader, announced that Huntsman Corporation has advanced its legal operations with Apttus' Contract Lifecycle Management (CLM) solution.

Key Points: 
  • SAN MATEO, Calif., April 30, 2020 /PRNewswire/ -- Apttus , the Middle Office leader, announced that Huntsman Corporation has advanced its legal operations with Apttus' Contract Lifecycle Management (CLM) solution.
  • "The Apttus platform has allowed us to centralize and manage our contracts, both on the sales and the procurement side," said Patrick Verraes, Deputy General Counsel at Huntsman.
  • By standardizing its global contracting process and introducing instant approvals via mobile using Apttus CLM, Huntsman has seen 40% faster contract cycle time, going from weeks or days to a matter of hours or minutes.
  • Analysts rank Apttus as the global gold standard for Quote-to-Cash (QTC) and Contract Lifecycle Management (CLM) solutions.