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EFPIA publishes open letter on EU trade mark reform, urging changes

EFPIA publishes open letter on EU trade mark reform, urging changes

21-10-2014

The EFPIA has published an open letter to the European Parliament, member states and the Commission on…

EuropeEuropean Federation of Pharmaceutical Industries and AssociationsEuropean ParliamentPharmaceuticalRegulation

EMA urging firms with Ebola candidates to seek orphan status

21-10-2014

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola…

Anti-viralsEuropePharmaceuticalRare diseasesRegulationResearchUSA

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

21-10-2014

The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration…

DermatologicalsNovartisPharmaceuticalRegulationsecukinumabUSA

FDA fast-tracks Taiho Oncology’s TAS-102 for colorectal cancer

FDA fast-tracks Taiho Oncology’s TAS-102 for colorectal cancer

20-10-2014

The US Food and Drug Administration has granted Fast Track designation for TAS-102 (trifluridine and…

OncologyOtsukaPharmaceuticalRegulationTaiho OncologyTAS-102USA

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

20-10-2014

Japanese drug major Eisai has had a supplemental New Drug Application for its in-house-discovered AMPA…

CNS DiseasesEisaiFycompaJapanPharmaceuticalRegulation

Pharmacyclics files Imbruvica sNDA for Waldenstrom’s macroglobulinemia

20-10-2014

US drugmaker Pharmacyclics has submitted a supplemental New Drug Application to the US Food and Drug…

ImbruvicaJanssen BiotechJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulationUSA

Clanotech granted orphan drug designation by EMA for post-glaucoma surgery drug CLT-28643

Clanotech granted orphan drug designation by EMA for post-glaucoma surgery drug CLT-28643

20-10-2014

Swedish ophthalmic specialist Clanotech, which is 80% owned by Karolinska Development, has received orphan…

ClanotechCLT-28643Karolinska DevelopmentOphthalmicsPharmaceuticalRegulationSweden

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

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

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

16-10-2014

The US Food and Drug Administration has approved Esbriet (pirfenidone), from Roche subsidiary Genentech,…

Boehringer IngelheimEsbrietGenentechnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

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

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

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

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

NICE updates guidance for management of multiple sclerosis but does not recommend Bayer's Sativex

NICE updates guidance for management of multiple sclerosis but does not recommend Bayer's Sativex

09-10-2014

The UK’s National Institute for Health and Care Excellence (NICE) has updated its guidance for the…

BayerNeurologicalPharmaceuticalRegulationSativexUK

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