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US FDA accepts for review Otsuka and Lundbeck’s sNDA for Abilify Maintena

US FDA accepts for review Otsuka and Lundbeck’s sNDA for Abilify Maintena

30-04-2014

Danish CNS specialist Lundbeck and the US subsidiary of Japan’s Otsuka Pharmaceutical revealed that…

Abilify MaintenaLundbeckNeurologicalOtsukaPharmaceuticalRegulationUSA

Otsuka wins EU approval for Deltyba in MDR-TB

30-04-2014

Japanese drugmaker Otsuka Pharmaceutical says that the European Commission has granted a marketing authorization…

Antibiotics and Infectious diseasesDeltybaEuropeOtsukaPharmaceuticalRegulation

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

09-04-2014

US biotech firm Alkermes saw its shares spike on Tuesday, after it announced positive top-line results…

AbilifyAlkermesaripiprazole lauroxilBiotechnologyLundbeckNeurologicalOtsukaRegulationResearch

Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

Japanese approval for Forxiga and Lonsurf

24-03-2014

Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved…

Asia-PacificAstraZenecaDiabetesForxigaJapanLonsurfOncologyOno PharmaceuticalOtsukaPharmaceuticalRegulationTaiho Pharmaceutical

Otsuka and Lundbeck’s schizophrenia drug Abilify Maintena approved in EU

Otsuka and Lundbeck’s schizophrenia drug Abilify Maintena approved in EU

21-11-2013

Japan’s Otsuka Pharmaceutical (TYO: 4768) and partner Lundbeck (LUN: CO) have received approval from…

Abilify MaintenaAsia-PacificEuropeLundbeckNeurologicalOtsukaPharmaceuticalRegulation

Otsuka's Samsca gains additional indication in Japan

17-09-2013

Japanese drugmaker Otsuka (TYO: 4768) says that its vasopressin V2 receptor antagonist Samsca (tolvaptan)…

Asia-PacificNephrology and HepatologyOtsukaPharmaceuticalRegulationSamscatolvaptan

Setback for Otsuka's tolvaptan

30-08-2013

The US subsidiary of Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has received a Complete Response…

Nephrology and HepatologyOtsukaPharmaceuticalRegulationRest of the Worldtolvaptan

Negative advisory view for Otsuka's tolvaptan in ADPKD

06-08-2013

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) says that the US Food and Drug Administration's…

Nephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRegulationtolvaptin

UK's NICE plans to recommend Abilify for children with bipolar disorder

10-06-2013

UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued new draft…

AbilifyEuropeLundbeckNeurologicalOtsukaPharmaceuticalPricingRegulation

US FDA accepts NDAs for Otsuka's tolvaptan and BTG's Varisolve

12-04-2013

Japanese mid-sized drugmaker Otsuka Pharmaceutical (TYO: 4578) says that the US Food and Drug Administration…

BTGCardio-vascularNephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRare diseasesRegulationtolvaptanVarisolve

EMA recommends restricting use of cilostazol-containing medicines

22-03-2013

The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended…

Cardio-vascularcilostazolEkistolEuropeOtsukaPharmaceuticalPletalRegulation

FDA approves Otsuka and Lundbeck's once-monthly Abilify Maintena for schizophrenia

01-03-2013

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) and Danish partner Lundbeck (LUND: DC) have received…

Abilify MaintenaAlkermesLundbeckNeurologicalNorth AmericaOtsukaPharmaceuticalRegulation

Taiho Pharma files for approval of cancer drug TAS-102 in Japan

27-02-2013

Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka (TYO: 4768) says that it submitted an…

Asia-PacificOncologyOtsukaPharmaceuticalRegulationTaiho PharmaceuticalTAS-102

Resubmission of aripiprazole NDA accepted; AstraZeneca bond issue

12-09-2012

Danish CNS-focused drugmaker Lundbeck (LUND: DC) and Japanese partner Otsuka Pharmaceutical (TYO: 4668)…

aripiprazole depotAstraZenecaFinancialLundbeckNeurologicalNorth AmericaOtsukaPharmaceuticalRegulation

Otsuka files Abilify, first antipsychotic for major depressive disorder in Japan

04-09-2012

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has filed an additional indication for Abilify (aripiprazole)…

AbilifyAsia-PacificNeurologicalOtsukaPharmaceuticalRegulation

Janssen-Cilag files for EU approval of bedaquiline in MDR-TB

02-09-2012

Johnson & Johnson (NYSE: JNJ) Belgium-based subsidiary Janssen-Cilag International submitted a Marketing…

Antibiotics and Infectious diseasesbedaquilinedelamanidEuropeJanssen-CilagJohnson & JohnsonOtsukaPharmaceuticalRegulation

Japanese filings for Shionogi's metreleptin and Otsuka's tolvaptin

06-08-2012

Japanese drugmaker Shionogi (TYO: 4507) said last week that it has filed a New Drug Application with…

Asia-PacificmetreleptinNephrology and HepatologyOtsukaPharmaceuticalRare diseasesRegulationSamscaShionogitolvaptin

Additional indication for Otsuka’s Abilify in Japan

22-01-2012

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) said last week that it has received new regulatory…

AbilifyAsia-PacificNeurologicalOtsukaPharmaceuticalRegulation

FDA accepts NDA for Lundbeck and Otsuka’s aripiprazole depot formulation

23-11-2011

Danish CNS drug specialist Lundbeck (LUND: DC) and its new partner Japan’s Otsuka Pharmaceutical…

aripiprazole depotLundbeckNeurologicalNorth AmericaOtsukaPharmaceuticalRegulation

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