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US FDA backs abuse deterrent labeling for Pfizer’s Embeda ER

19-10-2014

The US Food and Drug Administration has approved an updated label for pharma giant Pfizer’s Embeda…

AvinzaEmbedaNeurologicalPfizerPharmaceuticalRegulationUSA

Pharmacyclics’ Imbruvica gains EU approval for two blood cancers

17-10-2014

US drugmaker Pharmacyclics has received marketing approval from the European Commission for Imbruvica…

EuropeImbruvicaJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulation

ACCC proposes to strengthen new individual reporting in Australian pharmaceutical code

17-10-2014

The Australian Competition and Consumer Commission (ACCC) is proposing to grant conditional authorization…

AustraliaMarkets & MarketingPharmaceuticalRegulation

US FDA panel votes to keep Chantix black box warning; staffers recommend secukinumab

US FDA panel votes to keep Chantix black box warning; staffers recommend secukinumab

17-10-2014

The US Food and Drug Administration's advisory panel has voted to keep a black box warning on US pharma…

ChantixNovartisPfizerPharmaceuticalRegulationsecukinumabUSA

NICE reverses guidance on Novartis’ Glivec for GIST

NICE reverses guidance on Novartis’ Glivec for GIST

17-10-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new…

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

Actavis challenges Quillivant XR patent

16-10-2014

Ireland-headquartered generics major Actavis confirmed that it has filed an Abbreviated New Drug Application…

ActavisGenericsLegalNeurologicalPatentsPfizerQuillivantRegulationTris PharmaUSA

FDA FOCUS: The medical marijuana controversy

FDA FOCUS: The medical marijuana controversy

16-10-2014

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

MarinolPharmaceuticalRegulationUnited StatesUSA

ISPE unveils plan to prevent drug shortages

16-10-2014

Regulators from the European Medicines, the US Food and Drug Administration and the UK’s Medicines…

GlobalMarkets & MarketingPharmaceuticalProductionRegulation

Dendreon’s Provenge too expensive to be recommended, says NICE in draft guidance

Dendreon’s Provenge too expensive to be recommended, says NICE in draft guidance

16-10-2014

In preliminary draft guidance issued this morning the UK health costs watchdog the National Institute…

BiotechnologyDendreonOncologyPricingProvengeRegulationUK

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

15-10-2014

There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted…

BanzelEisailenvatinibNeurologicalOncologyPharmaceuticalRegulationRufinamide TabletsUSA

Northwest Bio says DCVax-L hospital exemption program under way in Germany

Northwest Bio says DCVax-L hospital exemption program under way in Germany

15-10-2014

US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for…

BiotechnologyDCVax-LGermanyNorthwest BiotherapeuticsOncologyRegulationResearch

FDA consent decree with Ascend Labs backed by federal judge

FDA consent decree with Ascend Labs backed by federal judge

15-10-2014

A federal judge from the US District Court for the Southern District of Ohio entered a consent decree…

Ascend LaboratoriesGenericsLegalProductionRegulationUSA

NICE preliminary guidance negative on Celgene’s pomalidomide for multiple myeloma

NICE preliminary guidance negative on Celgene’s pomalidomide for multiple myeloma

15-10-2014

UK medical costs watchdog the National Institute for Health and Care Excellence (NICE) has issued preliminary…

BiotechnologyCelgene Corp.ImnovidOncologyPricingRegulationUK

European Commission abandons plan to transfer control of pharma products to Industry Commissioner

European Commission abandons plan to transfer control of pharma products to Industry Commissioner

14-10-2014

Jean-Claude Juncker, President-elect of the European Commission, has backtracked on his decision to return…

Clinical researchEuropePharmaceuticalPoliticsRegulation

Pfizer’s palbociclib gains FDA Priority Review

13-10-2014

Pfizer says that the New Drug Application for its investigational breast cancer treatment palbociclib…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

FDA approves Eisai’s Akynzeo for CINV

13-10-2014

The US Food and Drug Administration has approved Japanese pharma major Eisai’s Akynzeo (netupitant…

AkynzeoEisaiHelsinnnetupitantOncologypalonosetronPharmaceuticalRegulationUSA

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

12-10-2014

As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationSovaldiUSA

Highlights from EMA Pharmacovigilance October meeting

10-10-2014

At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee…

Ariad PharmaceuticalsEuropeIclusigMen's HealthNeurologicalOncologyPharmaceuticalRegulationTestosteronevalproate

New Zealand approval of Novartis multiproduct proposal

10-10-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with…

NeurologicalNew ZealandOncologyPharmaceuticalRegulationRespiratory and Pulmonary

IQWiG finds added benefit of Novartis’ Gilenya not proven

IQWiG finds added benefit of Novartis’ Gilenya not proven

10-10-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

GermanyGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

Biogen Idec files for Elocta approval in Europe

Biogen Idec files for Elocta approval in Europe

10-10-2014

US biotech firm Biogen Idec has submitted a Marketing Authorization Application (MAA) for Elocta (rFVIIIFc;…

Biogen IdecBiotechnologyEloctaEloctateEuropeHematologyRegulationSwedish Orphan Biovitrum

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

09-10-2014

US privately-held oncolytic virus expert DNAtrix says that the US Food and Drug Administration has granted…

BiotechnologyDNAtrixDNX-2401OncologyRegulationUSA

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