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Scottish backing for Novartis’ Afinitor for kidney cancer patients

Scottish backing for Novartis’ Afinitor for kidney cancer patients

10-11-2014

The Scottish Medicines Consortium has issued a positive recommendation for Swiss pharma major Novartis’…

AfinitorClinical pharmacologyHealthHealth Medical PharmaNHSNovartisOncologyPharmaceuticalPricingRegulationUK

FDA Focus: The Sherley Amendment

FDA Focus: The Sherley Amendment

10-11-2014

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

Food and Drug AdministrationPharmaceuticalRegulationUnited StatesUSA

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

10-11-2014

Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have…

OncologyPerjetapertuzumabPharmaceuticalRegulationRocheUSA

Highlights of EMA Pharmacovigilance unit meeting

09-11-2014

At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee…

BayerBiogen IdecCSL BehringEuropeHelixateHematologyKogenateNeurologicalPharmaceuticalRegulationTecfidera

EMA PRAC’s recommendations to reduce risk of heart problems with ivabradine

09-11-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a…

AmgenCardio-vascularEuropeivabradinePharmaceuticalProcoralanRegulationServier

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

07-11-2014

The French pharma regulator, l’Agence nationale de sécurité du médicament et des produits de santé…

AvastinFranceOphthalmicsPharmaceuticalRegulationRoche

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

07-11-2014

The UK’s National Institute for Health and Care Excellence is consulting on provisional recommendations…

Anti-Arthritics/RheumaticsPfizerPharmaceuticalRegulationUKXiapex

FDA advisory panel votes against approval of Novartis MM drug

07-11-2014

At a meeting yesterday, the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC)…

LBH589NovartisOncologypanobinostatPharmaceuticalRegulationUSA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

06-11-2014

The Food and Drug Administration has approved US health care giant Johnson & Johnson's Olysio (simeprevir)…

Anti-viralsBiotechnologyJohnson & JohnsonMedivirOlysioRegulationsofosbuvirUSA

FDA declines approval of Macrilen, issuing CRL

06-11-2014

Canadian biopharma firm AEterna Zentaris has received a Complete Response Letter from the US Food and…

Aeterna ZentarisMacrilenMetabolicsPharmaceuticalRegulationUSA

Eisai “dismayed” by G-BA decision on Fycompa

06-11-2014

Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee…

EisaiFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Sarepta will rebound strongly from eteplirsen US delay, says analyst

06-11-2014

US rare and infectious disease specialist Sarepta Therapeutics remains a strong contender in the Duchenne…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationSarepta TherapeuticsUSA

Vertex seeks regulatory approval for lumacaftor/ivacaftor combination for CF

05-11-2014

US biotech firm Vertex Pharmaceuticals has filed for marketing approval for a fully co-formulated combination…

BiotechnologyEuropeivacaftorlumacaftorRare diseasesRegulationUSAVertex Pharmaceuticals

FDA responds to Public Citizen antacid petition from 2011

FDA responds to Public Citizen antacid petition from 2011

05-11-2014

The US Food and Drug Administration has responded to a 2011 petition from consumer rights advocacy group…

Gastro-intestinalsNexiumPharmaceuticalPrevacidPrilosecRegulationUSA

CNS drugs development takes longer than other drugs, says Tufts CSDD

05-11-2014

Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are…

NeurologicalPharmaceuticalRegulationResearchUSA

EGA and EBG see EMA latest biosimilars guidance as “important step forward”

EGA and EBG see EMA latest biosimilars guidance as “important step forward”

04-11-2014

The European Generic medicines Association (EGA) and the European Biosimilars Group (EBG), a sector group…

BiosimilarsEuropeGenericsRegulation

IQWIG confirms an additional benefit of Eisai's Halaven

IQWIG confirms an additional benefit of Eisai's Halaven

04-11-2014

Following a benefit:cost re-assessment, the German Institute for Quality and Efficiency in Health Care…

EisaiGermanyHalavenOncologyPharmaceuticalPricingRegulation

Added benefit of Takeda’s Entyvio is not proven, says IQWiG

Added benefit of Takeda’s Entyvio is not proven, says IQWiG

04-11-2014

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

EntyvioGastro-intestinalsGermanyPharmaceuticalPricingRegulationTakeda Pharmaceutical

New analysis of potential savings from Biosimilars in USA

New analysis of potential savings from Biosimilars in USA

04-11-2014

Introducing competing “biosimilar” versions of complex biologic drugs used to treat illnesses such…

Anti-Arthritics/RheumaticsBiosimilarsFinancialGenericsOncologyRegulationSandozUSA

UK's NICE recommends GSK's Arzerra for untreated chronic lymphocytic leukemia

UK's NICE recommends GSK's Arzerra for untreated chronic lymphocytic leukemia

04-11-2014

The UK’s National Institute for Health and Care Excellence has issued new preliminary draft guidance…

ArzerraGSKOfatumumab InjectionOncologyPharmaceuticalRegulationUK

Dutch MEB defines QR code policy

03-11-2014

The Netherlands Medicines Evaluation Board (MEB) has defined policy regarding the use of QR codes on…

NetherlandsPharmaceuticalRegulation

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