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Discussion launched about the future of biosimilars in Italy

Discussion launched about the future of biosimilars in Italy

23-10-2014

Results from a survey of 470 European physicians conducted by the Alliance for Safe Biologic Medicines…

BiosimilarBiosimilarsBiotechnologyItalyRegulation

EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

Cost of Australian PBS rises below rate of inflation for 2013-2014

Cost of Australian PBS rises below rate of inflation for 2013-2014

23-10-2014

The Australian Department of Health has confirmed that growth of the Pharmaceutical Benefits Scheme cost…

AustraliaMedicines AustraliaPharmaceuticalPharmaceuticals policyRegulation

UK’s NICE backs another use for Bayer’s Xarelto

UK’s NICE backs another use for Bayer’s Xarelto

23-10-2014

In draft guidance published today for consultation, the UK’s health costs watchdog the National Institute…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

FDA advisory backs expanded use of Vertex’ CF drug

22-10-2014

There was good news for US biotech firm Vertex Pharmaceuticals yesterday, as a US Food and Drug Administration…

BiotechnologyKalydecoRare diseasesRegulationUSAVertex Pharmaceuticals

NICE recommends another new skin cancer drug, GSK’s Tafinlar

22-10-2014

The UK National Institute for Health and Care Excellence (NICE) has issued final guidance recommending…

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationTafinlarUK

IQWiG finds no added benefit for GSK’s Anoro Ellipta in COPD

21-10-2014

According to the findings of an early benefit assessment under the German Act on the Reform of the Market…

Anoro ElliptaGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationRespiratory and Pulmonary

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

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