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AbbVie gains expanded approval for Humira by FDA

AbbVie gains expanded approval for Humira by FDA

06-10-2014

US drugmaker AbbVie has received approval from the US Food and Drug Administration for an extension of…

AbbVieAnti-Arthritics/RheumaticsHumiraPharmaceuticalRegulationUSA

French Transparency Commission recognizes efficacy of Eisai’s Zonegran monotherapy

French Transparency Commission recognizes efficacy of Eisai’s Zonegran monotherapy

06-10-2014

Transparency advice for Japanese pharma major Eisai’s Zonegran (zonisamide) monotherapy in the treatment…

EisaiFranceNeurologicalPharmaceuticalRegulationZonegran

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

06-10-2014

When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar…

BiosimilarsBiotechnologyDenmarkPharmacologyRegulation

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

04-10-2014

The US Food and Drug Administration has granted orphan drug designation for Ireland-headquartered specialty…

ActimmuneBiotechnologyHorizon PharmaRare diseasesRegulationUSA

Daiichi Sankyo seeks wider indication for Cravit in Japan

Daiichi Sankyo seeks wider indication for Cravit in Japan

03-10-2014

Japanese drug major Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) in Japan…

Antibiotics and Infectious diseasesCravitDaiichi SankyoJapanPharmaceuticalRegulation

Eli Lilly's Humalog KwikPen approved in Europe for new 200 units/ml version

Eli Lilly's Humalog KwikPen approved in Europe for new 200 units/ml version

03-10-2014

US drug major Eli Lilly has received marketing authorization from the European Commission for its Humalog…

DiabetesEli LillyEuropeHumalogPharmaceuticalRegulation

FDA Breakthrough designation for Ariad’s AP26113

FDA Breakthrough designation for Ariad’s AP26113

03-10-2014

US specialty pharma firm Ariad Pharmaceuticals says that its investigational cancer drug AP26113 has…

AP26113Ariad PharmaceuticalsOncologyPharmaceuticalRegulationResearchUSA

International Society for Pharmaceutical Engineering launches prevention plan to tackle drug shortages

International Society for Pharmaceutical Engineering launches prevention plan to tackle drug shortages

03-10-2014

The International Society for Pharmaceutical Engineering (ISPE) is to release its Drug Shortages Prevention…

GlobalISPEISPE Drug Shortages Task TeamPharmaceuticalRegulation

EMA adopts landmark policy to take effect January 2015

EMA adopts landmark policy to take effect January 2015

03-10-2014

In a bid toward greater transparency, the European Medicines Agency has decided to publish the clinical…

EMAEuropePharmaceuticalRegulationResearch

Data uncertainties mean NICE does not recommend Roche leukemia drug

Data uncertainties mean NICE does not recommend Roche leukemia drug

03-10-2014

In yet another rejection of the company’s cancer drugs, the UK drugs watchdog, the National Institute…

GazyvaroOncologyPharmaceuticalPricingRegulationRocheUK

New approach to global markets identifies six country archetypes

New approach to global markets identifies six country archetypes

02-10-2014

Similarities in pricing and reimbursement (P&R) decision criteria and payer requirements in key pharmaceutical…

GlobalMarkets & MarketingPharmaceuticalPharmaceutical industryRegulation

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

FDA grants approval for Xtandi in metastatic prostate cancer

FDA grants 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

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…

Cadila PharmaGenericsIndiaPricingRegulation

Innovative and orphan drugs to become more accessible in Russia

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…

PharmaceuticalPharmacologyRegulationResearchRussia

Bristol-Myers Squibb updates on Opdivo regulatory milestones

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

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