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UK’s NICE backs Lundbeck drug for alcohol dependence

UK’s NICE backs Lundbeck drug for alcohol dependence

10-07-2014

In new draft guidance, the UK drug watchdog the National Institute for Health and Care Excellence (NICE)…

LundbeckNeurologicalPharmaceuticalPricingRegulationSelincroUK

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

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

FDA accepts Lundbeck NDA for IV carbamazepine

FDA accepts Lundbeck NDA for IV carbamazepine

10-03-2014

The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted…

CarbamazepineCarbellaFinancialLigand PharmaceuticalsLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationUSA

Lundbeck’s Brintellix available in US pharmacies for depression

Lundbeck’s Brintellix available in US pharmacies for depression

22-01-2014

Lundbeck (LUN: CO) and Takeda Pharmaceutical (TYO: 4502) jointly announced today that Brintellix (vortioxetine)…

BrintellixLundbeckMarkets & MarketingNeurologicalPharmaceuticalRegulationTakeda PharmaceuticalsUSA

Lundbeck’s Brintellix OKed in Europe for adults with depression

Lundbeck’s Brintellix OKed in Europe for adults with depression

29-12-2013

The European Commission has granted marketing authorization for Danish CNS specialist Lundbeck’s Brintellix…

BrintellixLundbeckNeurologicalPharmaceuticalRegulation

FDA warns of serious skin reactions with the anti-seizure drug Onfi

FDA warns of serious skin reactions with the anti-seizure drug Onfi

04-12-2013

The US Food and Drug Administration is warning the public that the anti-seizure drug Onfi (clobazam)…

LundbeckNeurologicalNorth AmericaOnfiPharmaceuticalRegulation

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

New US indication for Lundbeck’s Sabril

New US indication for Lundbeck’s Sabril

29-10-2013

Danish CNS drug specialist Lundbeck says that the US Food and Drug Administration has approved its Sabril…

LundbeckNeurologicalNorth AmericaPharmaceuticalRegulationSabril

Positive EMA/CHMP opinions for Actelion and Lundbeck

Positive EMA/CHMP opinions for Actelion and Lundbeck

27-10-2013

At its October month-end meeting, the European Medicines Agency’s Committee for Medicinal Products…

ActelionBiotechnologyBrintellixEuropeLundbeckNeurologicalOpsumitPharmaceuticalRegulationRespiratory and Pulmonary

US FDA approves new drug Brintellix to treat major depressive disorder

US FDA approves new drug Brintellix to treat major depressive disorder

01-10-2013

The US Food and Drug Administration approved Brintellix on Monday, co-marketed by Takeda and Lundbeck…

BrintellixLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticals

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

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

Lundbeck buoyed as EU gives green light to alcohol addiction drug

01-03-2013

Danish pharma company Lundbeck (LUND: DC) is celebrating after winning European Union approval for Selincro…

EuropeLundbeckNeurologicalPharmaceuticalRegulationSelincro

Positive recommendations from EMA's CHMP for Selincro, Adasuve and Perjeta

17-12-2012

Last week's deliberations of the European Medicines Agency's Committee for Medicinal Products for Human…

AdasuveAlexza PharmaceuticalBiotechnologyEuropeFerrer InternacionalLundbeckNeurologicalOncologyPerjetaPharmaceuticalRegulationRocheSelincro

Regulatory briefs: Celgene's pomalidomide; Lundbeck's vortioxetine

21-09-2012

US biotech firm Celgene (Nasdaq: CELG) says that the US Food and Drug Administration's Oncologic Drugs…

Asia-PacificBiotechnologyCelgeneLundbeckNeurologicalNorth AmericaOncologyPharmaceuticalpomalidomideRegulationvortioxetine

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

Lundbeck gets marketing OK for Treanda in Canada

29-08-2012

Danish CNS drug specialist Lundbeck A/S (LUND: DC) says that medicines regulator Health Canada has approved…

LundbeckNorth AmericaOncologyPharmaceuticalRegulationTreanda

Lundbeck and Takeda to file for Lu AA21004 approval in USA and Europe on strong Ph III results

15-05-2012

Danish CNS drug specialist Lundbeck A/S (LUND: DC) yesterday announced positive top-line results from…

Lu AA21004LundbeckNeurologicalPharmaceuticalRegulationResearchTakeda Pharmaceuticals

Lundbeck submits Selincro in EU; Novo Nordisk files Degludec in Japan

22-12-2011

Danish CNS drug specialist Lundbeck (LUND: DC) revealed yesterday that it has submitted a marketing authorization…

Asia-PacificBiotie TherapiesDegludecDiabetesEuropeLundbeckNeurologicalNovo NordiskPharmaceuticalRegulationSelincro

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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