Actelion Pharmaceuticals US, Inc.

30 articles with Actelion Pharmaceuticals US, Inc.

• Actelion Withdraws Regulatory Filings to Extend the Indication of OPSUMIT® (macitentan 10mg) in CTEPH

  11/12/2019

  Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced its decision to voluntarily withdraw the European and other health authority filings still under review to extend the indication of OPSUMIT® (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

• New OPSUMIT® (macitentan) Data Show Initial Combination Therapy with Tadalafil Improved Hemodynamic Clinical and Functional Parameters in Patients with Pulmonary Arterial Hypertension

  10/21/2019

  OPSUMIT, as part of a combination regimen, reduced the primary endpoint of mean pulmonary vascular resistance by 47% at week 16 compared with baseline

• Owlstone Medical Enters into a Strategic Collaboration with Actelion to Develop a Breath-Based Test to Help Facilitate Early Detection of Pulmonary Hypertension

  5/20/2019

  Owlstone Medical announces a strategic collaboration with Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson and a global leader in pulmonary arterial hypertension, to discover and validate a breath-based test to help facilitate the early diagnosis of pulmonary hypertension and its subtypes.

• New Post-hoc Analysis Shows Adding UPTRAVI® (selexipag) Versus Placebo Improved Long-Term Clinical Outcomes Regardless of Time of Treatment Initiation, and Demonstrated an Even More Pronounced Treatment Effect When Initiated Early

  5/20/2019

  Actelion presents latest post-hoc analysis from the GRIPHON study - the largest randomized, controlled, outcome trial ever conducted in patients with pulmonary arterial hypertension (PAH)   [20-May-2019]   ALLSCHWIL, Switzerland , May 20, 2019 /PRNewswire/ -- Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has presented

• Third Pole Therapeutics Announces Inhaled Nitric Oxide Strategic Collaboration with Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson

  3/26/2019

  Third Pole Therapeutics announced that it has entered into a strategic collaboration to work with Actelion Pharmaceuticals Ltd, a Janssen pharmaceutical company of Johnson & Johnson.

• Interim Analysis Showed Treatment with OPSUMIT® (macitentan) Associated with Significant Improvement in Right Ventricular (RV) Function and Pulmonary Vascular Resistance (PVR) in Patients with Pulmonary Arterial Hypertension (PAH)

  3/15/2019

  Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today an interim analysis from the Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension (REPAIR) study of OPSUMIT®

• Actelion Receives Complete Response Letter from U.S. FDA for OPSUMIT® (Macitentan) Supplemental New Drug Application

  1/16/2019

  Actelion Pharmaceuticals Ltd announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for OPSUMIT® (macitentan) in the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve pulmonary vascular resistance (PVR) and exercise capacity.

• Analytics 4 Life® and Actelion Enter Research Agreement to Develop New Diagnostics for Pulmonary Hypertension

  12/11/2018

  Research endeavor marks a clinical research expansion of the CorVista® platform

• Azafaros B.V. Secures Seed Funding to Develop New Treatments in Rare Metabolic Disorders

  7/23/2018

  Azafaros, today announced the closing of a seed financing round. BioGeneration Ventures (BGV) is the founding investor.

• Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

  4/30/2018

  Filing supported by data from MERIT-1 trial evaluating OPSUMIT in adults with inoperable CTEPH which showed significant improvements in pulmonary vascular resistance and six-minute walk distance (6MWD) compared with ongoing background therapy

• Actelion Pharmaceuticals US, Inc. Release: Europe's Largest Biopharmaceutical Company Takes Big Leap into Procurement-Powered Business Performance With Zycus

  9/4/2014

• Actelion Pharmaceuticals US, Inc. Nabs Ceptaris Therapeutics, Inc. in $250 Million Buyout Deal

  8/1/2013

• Actelion Ltd. Shareholders Reject Executive Pay Plan

  4/19/2013

• Federal Trade Commission Slams Actelion Pharmaceuticals US, Inc. for Withholding Samples

  3/13/2013

• Auxilium Pharmaceuticals and Actelion Pharmaceuticals US, Inc. Announce Approval of XIAFLEX® In Canada

  7/9/2012

• FDA Approves Actelion Pharmaceuticals US, Inc.'s SNDA for Second Generation VELETRI for Injection

  6/29/2012

• Auxilium Pharmaceuticals and Actelion Pharmaceuticals US, Inc. Enter a Collaboration Agreement for XIAFLEX® in Canada, Australia, Brazil and Mexico for Up to $68.5 Million

  2/23/2012

• Actelion Pharmaceuticals US, Inc. Floods FDA With Patient Death Reports

  10/6/2011

• Actelion Pharmaceuticals US, Inc. Release: Pulmonary Hypertension Association Names Dr. Ronald Oudiz Recipient of 2011 Award of Excellence in Pulmonary Arterial Hypertension (PAH) Care

  5/18/2011

• Updated U.S. Product Labeling for Actelion Ltd.'s Veletri (Epoprostenol for Injection) Allows Patients to Prepare This Medication Up to a Week in Advance of Use for Pulmonary Arterial Hypertension

  10/5/2010