Cyclopropanes

CHMP Grants Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor) in People Ages 12 and Older With Cystic Fibrosis With the Most Common Genotypes

Retrieved on: 
Friday, June 26, 2020

In both studies, the ivacaftor/tezacaftor/elexacaftor plus ivacaftor combination regimen was generally well tolerated.

Key Points: 
  • In both studies, the ivacaftor/tezacaftor/elexacaftor plus ivacaftor combination regimen was generally well tolerated.
  • The clinical data for ivacaftor/tezacaftor/elexacaftor plus ivacaftor in people with CF ages 12 years and older with an F/F or F/MF genotype are unprecedented.
  • Mall, M.D., Head of Department of Pediatric Pulmonology, Immunology and Critical Care Medicine at Charit University Medical Center Berlin.
  • Both the clinical and patient communities are excited that more people with CF will be able to benefit from CFTR modulators.

COVID-19 Clinical Trial of Immune Therapy Open at Mount Sinai, Made Possible by Philanthropic Donation

Retrieved on: 
Thursday, June 18, 2020

NEW YORK, June 18, 2020 /PRNewswire-PRWeb/ -- Mount Sinai Health System is beginning the first clinical trial in the New York metropolitan region of an immune-boosting therapy in COVID-19 patients.

Key Points: 
  • NEW YORK, June 18, 2020 /PRNewswire-PRWeb/ -- Mount Sinai Health System is beginning the first clinical trial in the New York metropolitan region of an immune-boosting therapy in COVID-19 patients.
  • The Phase 2 randomized trial is expected to recruit 66 patients to study peginterferon lambda in hospitalized patients receiving supplemental oxygen.
  • Scott Friedman, MD, Dean for Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, sought out the maker of the therapy, Eiger Biopharmaceuticals.
  • This clinical trial will be important to determine if the drug has activity against COVID-19 in patients."

U.S. FDA Accepts PharmaEssentia’s Application for Ropeginterferon Alfa-2b to Treat Polythycemia Vera

Retrieved on: 
Thursday, June 4, 2020

At 36 months of treatment, patients who received Ropeginterferon alfa-2b maintained a complete hematological response longer than those who received HU/BAT (70.5% vs. 51.4%).

Key Points: 
  • At 36 months of treatment, patients who received Ropeginterferon alfa-2b maintained a complete hematological response longer than those who received HU/BAT (70.5% vs. 51.4%).
  • Response rates steadily increased in the Ropeginterferon alfa-2b arm throughout 24 months of treatment and remained constant after 36 months.
  • Further, after 36 months, two thirds (66.0%) of patients who received Ropeginterferon alfa-2b achieved a molecular response, compared with 27% in the HU/BAT arm.
  • Evidence for Superior Efficacy and Disease Modification after Three Years of Prospective Randomized Controlled Treatment of Polycythemia Vera Patients with Ropeginterferon Alfa-2b Vs. HU/BAT.

Eisai to Present Data on Oncology Pipeline and Products at ASCO20 Annual Meeting

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Thursday, May 14, 2020

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Key Points: 
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer.
  • There is no guarantee that any investigational compounds and investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • For more information about Eisai Co., Ltd., please visit https://www.eisai.com

CytoSorb® is E.U. Approved to Remove Rivaroxaban, a Leading Factor Xa Inhibitor and Novel Oral Anticoagulant, During On-Pump Cardiothoracic Surgery

Retrieved on: 
Tuesday, May 12, 2020

Given that CytoSorb is already being stocked in many heart centers for use during a variety of different on-pump cardiac surgery procedures, we believe it makes the decision to use CytoSorb to remove rivaroxaban relatively seamless.

Key Points: 
  • Given that CytoSorb is already being stocked in many heart centers for use during a variety of different on-pump cardiac surgery procedures, we believe it makes the decision to use CytoSorb to remove rivaroxaban relatively seamless.
  • We believe in time, CytoSorb has the potential to become a compelling and cost-effective standard of care for the removal of blood thinners during cardiac surgery."
  • CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.
  • CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorb® is E.U. Approved to Remove Rivaroxaban, a Leading Factor Xa Inhibitor and Novel Oral Anticoagulant, During On-Pump Cardiothoracic Surgery

Retrieved on: 
Tuesday, May 12, 2020

Given that CytoSorb is already being stocked in many heart centers for use during a variety of different on-pump cardiac surgery procedures, we believe it makes the decision to use CytoSorb to remove rivaroxaban relatively seamless.

Key Points: 
  • Given that CytoSorb is already being stocked in many heart centers for use during a variety of different on-pump cardiac surgery procedures, we believe it makes the decision to use CytoSorb to remove rivaroxaban relatively seamless.
  • We believe in time, CytoSorb has the potential to become a compelling and cost-effective standard of care for the removal of blood thinners during cardiac surgery."
  • CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.
  • CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

Enanta Pharmaceuticals to Present at the 2020 RBC Capital Markets Global Healthcare Virtual Conference

Retrieved on: 
Tuesday, May 12, 2020

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on May 19, 2020 at 9:45 a.m.

Key Points: 
  • Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on May 19, 2020 at 9:45 a.m.
  • A live webcast of the fireside chat will be accessible by visiting the Events and Presentations section on the Investors page of Enantas website at www.enanta.com .
  • A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.
  • Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection.

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2020 with Webcast and Conference Call Today at 4:30 p.m. ET

Retrieved on: 
Wednesday, May 6, 2020

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal second quarter ended March 31, 2020.

Key Points: 
  • Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal second quarter ended March 31, 2020.
  • With these catalysts in mind, we continue to monitor any impact of COVID-19 on all of our clinical studies.
  • Fiscal Second Quarter Ended March 31, 2020 Financial Results
    Total revenue for the three months ended March 31, 2020 was $27.6 million and consisted of royalty revenue derived primarily from worldwide net sales of AbbVies hepatitis C virus (HCV) regimen MAVYRET/MAVIRET (glecaprevir/pibrentasvir).
  • May 19, 2020 RBC Capital Markets Global Healthcare Conference, Virtual
    June 18, 2020 Raymond James Healthcare Conference, Virtual
    Enanta plans to issue its fiscal third quarter financial results press release, and hold a conference call regarding those results, on August 4, 2020.

Exelixis Announces First Quarter 2020 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 5, 2020

Based upon cabozantinib-related revenues generated by Exelixis partner Ipsen in the first quarter of 2020, Exelixis earned $17.9 million in royalty revenues.

Key Points: 
  • Based upon cabozantinib-related revenues generated by Exelixis partner Ipsen in the first quarter of 2020, Exelixis earned $17.9 million in royalty revenues.
  • In January 2020, Exelixis announced phase 1/2 clinical trial results from the combination of cabozantinib and nivolumab with or without ipilimumab in advanced HCC.
  • In February 2020, Exelixis announced positive efficacy and safety results from an interim analysis of the mCRPC Cohort 6 of COSMIC-021.
  • Exelixis management will discuss the companys financial results for the first quarter of 2020 and provide a general business update during a conference call beginning at 5:00 p.m. EDT / 2:00 p.m. PDT today, Tuesday, May 5, 2020.

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

Retrieved on: 
Tuesday, May 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.