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EC approves AbbVie’s Viekirax + Exviera for hepatitis C

EC approves AbbVie’s Viekirax + Exviera for hepatitis C

16-01-2015

The European Commission has granted marketing authorizations for US drugmaker AbbVie’s all-oral, short-course,…

AbbVieAnti-viralsEuropeExvieraPharmaceuticalRegulationViekirax

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

16-01-2015

In final draft guidance issued today, England health costs watchdog the National Institute for Health…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioPricingRegulationSovaldiUK

FDA committee votes to not recommend Ferring’s desmopressin

FDA committee votes to not recommend Ferring’s desmopressin

15-01-2015

The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has…

desmopressinFerring PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

FDA launches Office of Pharmaceutical Quality

FDA launches Office of Pharmaceutical Quality

14-01-2015

The US Food and Drug Administration has launched an Office of Pharmaceutical Quality in a bid to clamp…

Office of Pharmaceutical QualityPharmaceuticalPharmaceutical industryRegulationUSA

US FDA approves AbbVie’s Duopa for Parkinson’s disease

US FDA approves AbbVie’s Duopa for Parkinson’s disease

13-01-2015

The US Food and Drug Administration has approved US drugmaker AbbVie’s Duopa (carbidopa and levodopa)…

AbbVieCarbidopa-LevodopaNeurologicalPharmaceuticalRegulationUSA

Merck & Co updates on plans to accelerate new drug submissions and future growth

Merck & Co updates on plans to accelerate new drug submissions and future growth

13-01-2015

US pharma giant Merck & Co has reported on the ongoing execution of its multi-year, strategic initiative…

Anti-viralsgrazoprevir/elbasvirKeytrudaMerck & CoOncologyPharmaceuticalRegulationResearchUSA

Cost to NHS of Provenge too high to be recommended, says NICE

13-01-2015

England’s health care cost watchdog the National Institute for Health and Care Excellence (NICE) has…

BiotechnologyDendreonOncologyPricingProvengeRegulationUK

Hospira submits new BLA for epoetin alfa biosimilar In USA

12-01-2015

US injectable drugs and infusion technologies and biosimilars developer Hospira has submitted a Biologics…

AmgenBiosimilarsBiotechnologyepoetinEpogenHematologyHospiraJanssenJohnson & JohnsonProcritRegulationRetacritUSA

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

12-01-2015

French drug major Sanofi and US biotech company Regeneron have announced that the European Medicines…

alirocumabBiotechnologyCardio-vascularEuropeRegeneronRegulationSanofi

Australia needs targeted reform to reflect global regulatory environment: Medicines Australia chief

Australia needs targeted reform to reflect global regulatory environment: Medicines Australia chief

12-01-2015

Australian pharma representative body Medicines Australia has put forward its recommendations for consideration…

AustraliaMedicines AustraliaPharmaceuticalRegulationTechnology

China’s FDA approves Chipscreen’s Epidaza

China’s FDA approves Chipscreen’s Epidaza

12-01-2015

Chinese biotech firm Chipscreen Biosciences has received regulatory approval of Epidaza (chidamide),…

BiotechnologychidamideChinaChipscreen BiosciencesEpidazaOncologyRegulation

EMA backs record number of drugs for rare diseases in 2014

EMA backs record number of drugs for rare diseases in 2014

11-01-2015

The European Medicines Agency recommended the highest number of orphan designated medicines for marketing…

CyramzaEuropeGazyvaroHoloclarImbruvicaMekinistPharmaceuticalRegulationScenesseTranslarna

Standardization of European HTA bodies is inevitable: EFPIA head

Standardization of European HTA bodies is inevitable: EFPIA head

09-01-2015

The director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA)…

EFPIAEuropeMarkets & MarketingPharmaceuticalPricingRegulation

FDA’s acting director explains aims of new Office of Pharmaceutical Quality

FDA’s acting director explains aims of new Office of Pharmaceutical Quality

09-01-2015

This week the Acting Director of US Food and Drug Administration’s Center for Drug Evaluation and Research’s…

RegulationUSA

FDA sees no need for advisory panel meeting over Pfizer’s Ibrance

09-01-2015

US pharma giant Pfizer says it has been advised by the Food and Drug Administration that at this time…

IbranceOncologypalbociclibPfizerPharmaceuticalRegulationUSA

Favorable investment climate and health care reforms will fuel Turkey’s life sciences industry; report

09-01-2015

Big pharmaceutical companies and foreign investors are flocking to Turkey to capitalize on its encouraging…

Markets & MarketingPharmaceuticalPricingRegulationTurkey

FDA approves Daiichi Sankyo’s anti-clotting drug Savaysa

09-01-2015

The US Food and Drug Administration late yesterday approved Japanese drug major Daiichi Sankyo’s anti-clotting…

Cardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulationSavaysaUSA

FDA Focus: Recalling dangerous and defective drugs

FDA Focus: Recalling dangerous and defective drugs

08-01-2015

In a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at how…

DrugsPharmaceuticalRegulationUnited StatesUSA

ViiV’s Triumeq offers added benefit for treatment-naive adults with HIV, says IQWiG

ViiV’s Triumeq offers added benefit for treatment-naive adults with HIV, says IQWiG

08-01-2015

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), which had already assessed a…

Anti-viralsGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTriumeqViiV Healthcare

BIO urges US FDA to release guidance on biosimilars

BIO urges US FDA to release guidance on biosimilars

08-01-2015

The US trade group the Biotechnology Industry Organization (BIO) has called on the Food and Drug Administration…

BiosimilarsBiotechnologyRegulationUSA

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

FDA grants Soligenix Fast Track status for SGX301

FDA grants Soligenix Fast Track status for SGX301

07-01-2015

Late-stage biopharma company Soligenix has said that its SGX301 (synthetic hypericin) development program…

OncologyPharmaceuticalRegulationSGX301SoligenixUSA

Shield Therapeutics' MAA for Ferracru accepted for review by EMA

Shield Therapeutics' MAA for Ferracru accepted for review by EMA

07-01-2015

Independent UK pharma company Shield Therapeutics has received acceptance for review of the Marketing…

FerracruHematologyPharmaceuticalRegulationShield TherapeuticsUK

CHMP recommends approval of Newron/Zambon's Xadago for Parkinson's disease

CHMP recommends approval of Newron/Zambon's Xadago for Parkinson's disease

07-01-2015

Italy-based Newron Pharmaceuticals and its partner Zambon have received a recommendation from the Euroean…

ItalyNeurologicalNewron PharmaceuticalsPharmaceuticalRegulationXadagoZambon

37 to 61 of 2735 results

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