Cyclopropanes

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

Thursday, May 14, 2020 - 1:22am

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

Tuesday, May 12, 2020 - 12:08pm

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

Tuesday, May 12, 2020 - 12:08pm

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

Tuesday, May 12, 2020 - 12:30pm

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

Wednesday, May 6, 2020 - 9:03pm

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

Tuesday, May 5, 2020 - 9:05pm

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)

Tuesday, May 5, 2020 - 12:00pm

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.

Development Update: U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery

Monday, April 20, 2020 - 11:58am

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification.

Key Points: 
  • CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification.
  • These are conditions where the risk of death is extremely high, yet no effective treatments exist.
  • CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.
  • CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

BRILINTA reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial

Monday, March 30, 2020 - 2:16pm

BRILINTA is not indicated for use without aspirin or in patients undergoing PCI who have not had an ACS event.

Key Points: 
  • BRILINTA is not indicated for use without aspirin or in patients undergoing PCI who have not had an ACS event.
  • BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
  • When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding.
  • The TWILIGHT subgroup analyses evaluated patients with diabetes (TWILIGHT-DM) and patients who had successfully undergone a complex PCI (TWILIGHT-COMPLEX).

Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) Tablets for the Treatment of Curatively Unresectable or Metastatic Renal Cell Carcinoma

Wednesday, March 25, 2020 - 7:01am

In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.

Key Points: 
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.
  • Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis.