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FDA Focus: Life-threatening disease and the benefit-risk of treatment options

FDA Focus: Life-threatening disease and the benefit-risk of treatment options

10-12-2014

In the fifth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

ChemistryFDAPharmaceuticalRegulationUSA

Supernus notified of Par Pharma ANDA filing for Trokendi XR generic

09-12-2014

US drugmaker Supernus Pharmaceuticals says that it has received a Paragraph IV Notice Letter from privately-held…

GenericsNeurologicalPar PharmaceuticalsPatentsRegulationSupernus PharmaceuticalsTrokendi XRUSA

AstraZeneca’s Moventig gains EU approval for OIC

09-12-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaEuropeGastro-intestinalsMoventigNektar TherapeuticsPharmaceuticalRegulation

China’s new regulatory process could cause delays, RDPAC warns

China’s new regulatory process could cause delays, RDPAC warns

09-12-2014

Concerns have been raised in China that regulatory delays could defer the introduction of new drugs into…

BloombergChinaPharmaceuticalR&D-Based Pharmaceutical Association CommitteeRegulation

NICE now proposes to recommend Stelara for psoriatic arthritis

NICE now proposes to recommend Stelara for psoriatic arthritis

09-12-2014

UK health cost watchdog, the National Institute for Health and Care Excellence (NICE) has opened a consultation…

Anti-Arthritics/RheumaticsBiotechnologyInflammatory diseasesJanssenJohnson & JohnsonPricingRegulationStelaraUK

FDA approves new indication for Amgen's Xgeva

FDA approves new indication for Amgen's Xgeva

08-12-2014

USA-based Amgen says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab),…

AmgenBiotechnologyOncologyRare diseasesRegulationUSAXgeva

EFPIA responds to European Commission's patent settlement report with own transparency proposal

EFPIA responds to European Commission's patent settlement report with own transparency proposal

08-12-2014

The European Commission has published its fifth Monitoring Report of Patent Settlements in the pharma…

EuropeEuropean CommissionLegalPharmaceuticalRegulation

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

08-12-2014

The Scottish Medicines Consortium has decided to grant access to Gazyvaro (obinutuzumab), manufactured…

AdempasBayerCardio-vascularGazyvaroOncologyPharmaceuticalRegulationRoche

A top-20 pharma to utilize Xyntek-Antares serializing for China

A top-20 pharma to utilize Xyntek-Antares serializing for China

08-12-2014

A top 20 multi-national pharmaceutical research and manufacturer is utilizing the Xyntek-Antares solution…

ChinaPharmaceuticalProductionRegulationXyntek

Labeling update of Lundbeck and Otsuka’s Abilify Maintena approved by FDA

08-12-2014

The US Food and Drug Administration approved the labeling update of Abilify Maintena (aripiprazole) for…

Abilify MaintenaLundbeckNeurologicalOtsuka PharmaceuticalPharmaceuticalRegulationUSA

Bayer files for European approval of hemophilia A drug BAY 81-8973

06-12-2014

German pharma major Bayer has filed an application for marketing authorization to the European Medicines…

BAY 81-8973BayerEuropeHematologyPharmaceuticalRegulation

FDA advisory panel backs Actavis’ ceftazidime-avibactam

06-12-2014

Ireland-headquartered generic drugs major Actavis says that the Anti-Infective Drugs Advisory Committee…

ActavisAntibiotics and Infectious diseasesAstraZenecaceftazidime-avibactamPharmaceuticalRegulationUSA

EMA update on review of studies performed at GVK Biosciences site in Hyderabad, India

06-12-2014

Some European Union member states have decided to suspend the marketing authorizations of medicines that…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

Turning a constraint into an enabler: transparency round-table at Veeva's commercial summit 2014

Turning a constraint into an enabler: transparency round-table at Veeva's commercial summit 2014

05-12-2014

In one of the opening sessions, cloud-based life sciences provider Veeva’s co-founder and president…

BMI SystemEuropeInterviewsPharmaceuticalRegulationVeeva

Mixed findings from IQWiG on added benefit for Eliquis

05-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined a dossier on Eliquis…

Bristol-Myers SquibbCardio-vascularEliquisGermanyPfizerPharmaceuticalPricingRegulation

Takeda receives Breakthrough designation for ixazomib

Takeda receives Breakthrough designation for ixazomib

05-12-2014

Japanese drug major Takeda Pharmaceutical’s has been granted Breakthrough Therapy designation from…

ixazomibPharmaceuticalRare diseasesRegulationTakeda PharmaUSA

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

05-12-2014

The US Food and Drug Administration has granted tentative approval for New Drug Applications by US generic…

Abacavir Sulfate and Lamivudine TabletsAnti-viralsGenericsMylanRegulationUSA

Credit Suisse sees PTC Therapeutics as a top stock pick

05-12-2014

Credit Suisse has released a biotech research report from analysts Jason Kantor and Jeremiah Shepard…

BiotechnologyFinancialNeurologicalPTC TherapeuticsRare diseasesRegulationTranslarna

US FDA approves new indication for Incyte’s Jakafi

US FDA approves new indication for Incyte’s Jakafi

05-12-2014

The US Food and Drug Administration yesterday approved a new use for Incyte Corp’s Jakafi (ruxolitinib)…

BiotechnologyIncyteJakafiOncologyRegulationUSA

FDA guidance for prospective ANDA sponsors

FDA guidance for prospective ANDA sponsors

04-12-2014

The US Food and Drug Administration has issued new guidance in its efforts to assist in certain circumstances…

FDAGenericsPharmaceutical sciencesRegulationUSA

Added benefit of Lundbeck’s Selincro not proven, says IQWiG

04-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment…

GermanyLundbeckNeurologicalPharmaceuticalPricingRegulationSelincro

EMA committee concludes no evidence Fluad caused deaths

EMA committee concludes no evidence Fluad caused deaths

04-12-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that…

EuropeFluadNovartisPharmaceuticalRegulationVaccines

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

04-12-2014

Ahead of the anticipated decision date, the US Food and Drug Administration yesterday approved Blincyto…

AmgenBiotechnologyblinatumomabBlincytoOncologyRegulationUSA

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