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NICE recommends Lundbeck’s Selincro for alcohol dependence

NICE recommends Lundbeck’s Selincro for alcohol dependence

02-10-2014

Today’s announcement that the UK’s National Institute for Health and Care Excellence (NICE) recommends…

Biotie TherapiesLundbeckNeurologicalPharmaceuticalPricingRegulationSelincroUK

Hospira warned by FDA over Australian manufacturing facility

Hospira warned by FDA over Australian manufacturing facility

02-10-2014

USA-based injectable generic drugs specialist Hospira revealed in a filing with the US Securities and…

AustraliaGenericsHospiraProductionRegulationUSA

Health Canada issues import ban from three Indian drug plants

Health Canada issues import ban from three Indian drug plants

01-10-2014

Regulator Health Canada has taken action to stop the imports from three Indian manufacturing sites.

Apotex Research Private LimitedCanadaIndiaIpca LaboratoriesPharmaceuticalRegulation

Diplomat pharmacy receives expanded FDA approval for Xtandi in metastatic prostate cancer

Diplomat pharmacy receives expanded FDA approval for Xtandi in metastatic prostate cancer

01-10-2014

Japanese drug major Astellas Pharma and Medivation has received extended approval for Xtandi (enzalutamide)…

Astellas PharmaDiplomatMedivationOncologyPharmaceuticalRegulationUSAXtandi

Indian government takes action over dubious fixed-dose combinations

30-09-2014

In a bid to weed out potentially unsafe combinations, the Central Drugs Standards and Control Organization…

GenericsIndiaPricingRegulation

Innovative and orphan drugs to become more accessible in Russia

30-09-2014

The Russian Parliament (State Duma) plans to ease access to innovative and orphan drugs to the Russian…

PharmaceuticalRegulationResearchRussia

Bristol-Myers Squibb updates on Opdivo regulatory milestones

30-09-2014

US pharma major Bristol-Myers Squibb has announced multiple regulatory milestones for Opdivo (nivolumab),…

Bristol-Myers SquibbEuropeOncologyOno PharmaceuticalOpdivoPharmaceuticalRegulationUSA

ESMO 2014: Canada and Europe sometimes years slower than USA in approving cancer

ESMO 2014: Canada and Europe sometimes years slower than USA in approving cancer

29-09-2014

Access to potentially life-extending cancer drugs varies significantly in different regions of the world,…

CanadaEastern EuropeEuropeOncologyPharmaceuticalRegulationUSA

Added indication for Daiichi Sankyo’s Lixiana in Japan

Added indication for Daiichi Sankyo’s Lixiana in Japan

29-09-2014

The Japanese Ministry of Health, Labor and Welfare has granted approval for domestic pharma major Daiichi…

Cardio-vascularDaiichi SankyoJapanLixianaPharmaceuticalRegulation

Update: Negotiations on EU-Canada Free Trade Agreement concluded

Update: Negotiations on EU-Canada Free Trade Agreement concluded

29-09-2014

Canadian trade group Research-Based Pharmaceutical Companies (Rx&D) expressed its support to the government…

CanadaEuropeGenericsMarkets & MarketingPatentsPoliticsRegulation

US FDA approves Iluvien for diabetic macular edema

US FDA approves Iluvien for diabetic macular edema

28-09-2014

US ophthalmic drug specialist Alimera Sciences says that the US Food and Drug Administration has approved…

Alimera SciencesIluvienMedidurOphthalmicsPharmaceuticalpSividaRegulationTethadurUSA

Actavis files ANDA for generic of Purdue's Butrans

Actavis files ANDA for generic of Purdue's Butrans

26-09-2014

Ireland-headquartered generics major Actavis has filed an Abbreviated New Drug Application with the US…

ActavisAnalgesiaBuprenorphineButransGenericsLegalPurdue PharmaRegulationUSA

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

25-09-2014

German family-owned pharma major Boehringer Ingelheim Pharmaceuticals has received US Food and Drug Administration…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivaUSA

AbbVie's Humira gains added indication from US FDA

AbbVie's Humira gains added indication from US FDA

25-09-2014

The US Food and Drug Administration has approved US drugmaker AbbVie’s Humira (adalimumab) for reducing…

AbbVieGastro-intestinalsHumiraInflammatory diseasesPharmaceuticalRegulationUSA

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

25-09-2014

Switzerland-based Celgene International, a wholly-owned subsidiary of US biotech major Celgene, say that…

AbraxaneBiotechnologyCelgene Corp.OncologyRegulationSwitzerland

FDA warning letters rise 78% over six years with increase expected in 2015

FDA warning letters rise 78% over six years with increase expected in 2015

25-09-2014

The number of warning letters sent by the US Food and Drug Administration increased substantially by…

PharmaceuticalRegulationUSA

Gilead files for Japanese approval of ledipasvir/sofosbuvir for hepatitis C

24-09-2014

Gilead Sciences has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationsofosbuvir

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

24-09-2014

The UK’s drug watchdog the National Institute for Health and Care Excellence (NICE) has today issued…

BiotechnologyCelgene Corp.OncologyPricingRegulationRevlimidUK

NICE opens consultation on three drugs for chronic bowel condition

NICE opens consultation on three drugs for chronic bowel condition

24-09-2014

Three drugs to treat ulcerative colitis, a chronic bowel condition, have not been proven to be more cost…

AbbVieGastro-intestinalsHumiraMerck & CoPharmaceuticalPricingRegulationRemicadeSimponi InjectionUK

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