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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

Auxilium's supplemental Biologics Application for Xiaflex approved by FDA

Auxilium's supplemental Biologics Application for Xiaflex approved by FDA

21-10-2014

Specialty biopharma company Auxilium Pharmaceuticals has received approval from the US Food And Drug…

Anti-Arthritics/RheumaticsAuxilium PharmaceuticalsBiotechnologyRegulationUSAXiaflex

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

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

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