Pharmaceuticals
News Releases
News releases related to cardiovascular & renal areas
2024
Pharmaceuticals
Sibeprenlimab Received U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy (IgAN)
Pharmaceuticals
Novartis Obtains Approval for Additional Indication of Pediatric Chronic Heart Failure for Angiotensin Receptor Neprilysin Inhibitor (ARNI) Entresto® Tablet = Novartis and Otsuka to provide information to healthcare professionals on additional indication for Entresto =
2023
2022
Pharmaceuticals
Otsuka announces EC approval of Lupkynis® (voclosporin) as first oral treatment for active lupus nephritis
Pharmaceuticals
Otsuka receives positive CHMP opinion for LupkynisTM (voclosporin)for the treatment of active lupus nephritis
Pharmaceuticals
Launch in Japan of SAMTASU® for IV Infusion, a V2 -Receptor Antagonist for the Treatment of Cardiac Edema
Pharmaceuticals
Announcement of Termination of Global License Agreements for Renal Anemia Treatment with Akebia Therapeutics, Inc.
Pharmaceuticals
Akebia Therapeutics Receives Complete Response Letter from U.S. FDAfor Vadadustat for the Treatment of Anemia associated with Chronic Kidney Diseasein Adult Patients
Pharmaceuticals
Otsuka Obtains Approval in Japan for SAMTASU® for I.V. Infusion, a V2 -Receptor Antagonist for the Treatment of Cardiac Edema
2021
Pharmaceuticals
Otsuka submits initial marketing authorization application to the European Medicines Agency for vadadustat for the treatment of adults with anemia associated with chronic kidney disease
Pharmaceuticals
Otsuka announces that Novartis Pharma's ENTRESTO® received a new indication for treatment of hypertension in Japan
Pharmaceuticals
Otsuka Has Filed a Marketing Authorization Application to the European Medicines Agency for Voclosporin for the Treatment of Patients with Lupus Nephritis
Pharmaceuticals
Otsuka and Akebia Announce U.S. FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease
Pharmaceuticals
Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia's Vadadustat
Pharmaceuticals
Otsuka Has Filed an Application in Japan for Regulatory Approval of OPC-61815, a V2 -Receptor Antagonist for the Treatment of Cardiac Edema
2020
Pharmaceuticals
Formation of a Licensing Agreement Covering Japan and Europe for the Lupus Nephritis Drug "Voclosporin"
Pharmaceuticals
Positive Top-Line Results in Phase 3 Trial of OPC-61815, a V2 -Receptor Antagonist for the Treatment of Cardiac Edema
Pharmaceuticals
Top-line Results from Global Phase 3 Program of Vadadustat, a Drug Candidate for Treatment of Renal Anemia due to Chronic Kidney Disease in Non-Dialysis Patients
Pharmaceuticals
Novartis Pharma and Otsuka to Launch Entresto® Tablets in Japan for Patients with Chronic Heart Failure
Pharmaceuticals
Novartis Pharma obtains manufacturing and marketing approval in Japan for Entresto® tablet as angiotensin receptor neprilysin inhibitor (ARNI) for chronic heart failure
Pharmaceuticals
Samsca®approved in Japan for additional indication of hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Pharmaceuticals
Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis
Pharmaceuticals
Otsuka Enters into Licensing Agreement in Japan for Bempedoic Acid, a Treatment for Hypercholesterolemia
Pharmaceuticals
Otsuka enters into co-promotion agreement for angiotensin receptor neprilysin inhibitor (ARNI) LCZ696 in Japan
Pharmaceuticals
Otsuka Pharmaceutical and the Japan Kidney Association Form Collaborative Agreement -Aim to identify practical uses of basic research in the kidney field-
2019
2017
Pharmaceuticals
Otsuka and DKSH to commence sales of Otsuka prescription drugs in Myanmar
Pharmaceuticals
U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan in the Treatment of ADPKD
Pharmaceuticals
Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Pharmaceuticals
Smart Medicine Container for Anti-stroke Medicine Approved for Sale in Japan
Pharmaceuticals
Additional Formulation of Samsca® Granules 1% Available in Japan
Pharmaceuticals
Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S.
Pharmaceuticals
Otsuka and Akebia Concludes Licensing Agreement for Akebia's Renal Anemia Drug Vadadustat - Development and marketing territories include Europe, China, etc. -
Pharmaceuticals
Approval for the Additional Formulation of Samsca® Granules 1% in Japan
Pharmaceuticals
Otsuka Files a Supplemental Application in Japan: A Plastic Case with Anti-Stroke Medicine for a Smart Medicine Container
2016
Pharmaceuticals
Akebia Therapeutics and Otsuka Pharmaceutical Announce Collaboration to Develop and Commercialize Vadadustat in the U.S.
Pharmaceuticals
Otsuka and NEC agree to develop a smart medicine container to assist patients in taking daily anti-stroke medication at the appropriate time
Pharmaceuticals
Otsuka receives two commendations by the Japanese Government for the development of an anti-tuberculosis agent and an aquaretic/ADPKD treatment
2014
Pharmaceuticals
A Marker to Monitor Treatment Effectiveness For Chronic Myeloid Leukemia(CML) Approval in Japan for Otsuka's Major BCR-ABL mRNA Measurement Kit
Pharmaceuticals
Meptin®, a Fast-acting Bronchodilator to Treat Asthma and COPD, Will Become Available in Japan on July 2 in a New Form as Meptin® Swinghaler® 10μg 100Puffs
Pharmaceuticals
"QuickNavi Strep A" April 14 Market Launch in Japan Test Kit for the Rapid Detection of Group A Beta-hemolytic Streptococcal Antigen
Pharmaceuticals
Otsuka and Takeda Announce a Co-promotion Agreement in Japan of TAK-438 For the Treatment of Acid-related Diseases in the Gastrointestinal Therapeutic Area
Pharmaceuticals
Meptin Swinghaler, Easy-to-inhale Bronchodilator for COPD and Asthma Patients, Approved in Japan
2013
Pharmaceuticals
Vasopressin V2 Receptor Antagonist Samsca®7.5mg Tablets Granted Additional Indication in Japan for the Treatment of Fluid Retention in Patients with Hepatic Cirrhosis
Pharmaceuticals
Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Pharmaceuticals
Vasopressin V2 Receptor Antagonist Samsca® 7.5mg Tablets To Be Launched in Japan on June 4 - Additional Choice of Dose for the Treatment of Volume Overload in Patients with Heart Failure
Pharmaceuticals
7.5mg Tablets Additionally Approved - Samsca®, Vasopressin V2 Receptor Antagonist
2012
Pharmaceuticals
Otsuka's Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD), Tolvaptan, Meets Primary Endpoint in a Phase III Clinical Trial
Pharmaceuticals
Vasopressin V2-Receptor Antagonist, Samsca® Tablets Were Filed Additional Indication of the Treatment of Fluid Retention Associated with Cirrhosis of the Liver
2010
Pharmaceuticals
World's First Aquaretic Agent for the Treatment of Volume Overload in Patients with Heart Failure Samsca® Tablets 15mg (tolvaptan), Vasopressin V2-Receptor Antagonist, to be Launched in Japan on December 14
Pharmaceuticals
SAMSCA™ Tablets 15mg (tolvaptan), Vasopressin V2-Receptor Antagonist, Receive Regulatory Approval in Japan
Pharmaceuticals
The Antiplatelet Agent Pletaal® (Nonproprietary Name: Cilostazol) The Results of CSPS 2, a Large-Scale Clinical Trial of Cilostazol in Preventing Recurrent Strokes, Posted on the Online Version of The Lancet Neurology
Pharmaceuticals
First Antithrombotic Orally Disintegrating Tablets Antiplatelet Agent "Pletaal® OD Tablets" Launched on April 26
Pharmaceuticals
The Results of CSPS II, a Large-scale Clinical Trial of Cilostazol in Preventing Recurrent Strokes, Presented at American Stroke Association's International Stroke Conference on February 26
2009
Pharmaceuticals
The European Commission Approves SAMSCA™ (tolvaptan), Europe's First and Only Oral Vasopressin Antagonist for Hyponatraemia Secondary to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) .
Pharmaceuticals