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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

FDA study shows Pradaxa reduces stroke risk but raises chances of GI bleeding

FDA study shows Pradaxa reduces stroke risk but raises chances of GI bleeding

03-11-2014

A study carried out by the US Food and Drug Administration on Pradaxa (dabigatran etexilate mesylate)…

Boehringer IngelheimHematologyPharmaceuticalPradaxaRegulationResearchUSAWarfarin Sodium

Spanish pharmaceutical market development

03-11-2014

Spanish pharma trade group Farmaindustria’s general assembly gathered in Madrid last week to hold an…

Esteve GroupManagementPharmaceuticalPricingRegulationSpain

Eisai's Fycompa launches in Australia for seizures

Eisai's Fycompa launches in Australia for seizures

03-11-2014

Fycompa (perampanel), manufactured by Japanese drug major Eisai, has been approved for reimbursement…

AustraliaEisaiFycompaNeurologicalPharmaceuticalRegulation

US FDA advisory panel backs Daiichi Sankyo’s Savaysa for stroke risk and SEE

03-11-2014

A US Food and Drug advisory panel has voted in favor of the use of Japanese pharma major Daiichi Sankyo’s…

Cardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulationSavaysaUSA

Biogen Idec and SOBI’s Elocta MAA validated in Europe

01-11-2014

Biotechnology companies Biogen Idec of the USA and Swedish Orphan Biovitrum said on Friday that the European…

Biogen IdecBiotechnologyEloctaEloctateEuropeHematologyRegulationSwedish Orphan Biovitrum

US FDA reveals discussions with Sarepta over eteplirsen

US FDA reveals discussions with Sarepta over eteplirsen

31-10-2014

In what is viewed as an unusual step, the US Food and Drug Administration made a website posting of its…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationResearchSarepta TherapeuticsUSA

Specialised Therapeutics' Abraxane to be reimbursed via Australian PBS

Specialised Therapeutics' Abraxane to be reimbursed via Australian PBS

31-10-2014

Australian biopharma company Specialised Therapeutics is to have its Abraxane (nanoparticle albumin-bound…

AbraxaneAustraliaBiotechnologyOncologyRegulationSpecialised Therapeutics Australia

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