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US and EU regulatory filings for UCB’s antiepileptic brivaracetam

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

21-01-2015

Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European…

BRIVARACETAMEuropeNeurologicalPharmaceuticalRegulationUCBUSA

EMA launches public consultation on clinical trial transparency proposals

EMA launches public consultation on clinical trial transparency proposals

21-01-2015

The European Medicines Agency has launched a public consultation on how the transparency rules of the…

Clinical researchEuropeEuropean UnionPharmaceuticalRegulation

Naming conventions for biosimilars in Australia

Naming conventions for biosimilars in Australia

21-01-2015

Following recent international developments in the area of biosimilar naming, Australian regulator the…

AustraliaBiosimilarsBiotechnologyRegulationTherapeutic Goods Administration

US FTC approves final order preserving in nicotine patches market competition

US FTC approves final order preserving in nicotine patches market competition

21-01-2015

Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling…

GlaxoSmithKlineHabitrolMergers & AcquisitionsNeurologicalNovartisPharmaceuticalRegulationUSA

New phase of MAb biosimilars opportunities in Japan

New phase of MAb biosimilars opportunities in Japan

21-01-2015

The launch of Remicade (infliximab, from Johnson & Johnson) biosimilar in December 2014 in the Japan…

BiosimilarserythropoietinGenericsJapanMarkets & MarketingRegulationRemicade

Novo Nordisk's Victoza granted label extension in the UK

Novo Nordisk's Victoza granted label extension in the UK

20-01-2015

A license extension has been granted in the UK for Victoza (liraglutide) from Danish insulin giant Novo…

Nephrology and HepatologyNovo NordiskPharmaceuticalRegulationUKVictoza

Ariad gets positive final EC decision on Iclusig

20-01-2015

USA-based Ariad Pharmaceuticals today revealed that the European Commission has endorsed the final opinion…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalRegulation

FDA removes hold on CytRx's aldoxorubicin Phase III trials

FDA removes hold on CytRx's aldoxorubicin Phase III trials

20-01-2015

The US Food and Drug Administration has removed the partial clinical hold on biopharma oncology company…

aldoxorubicinBiotechnologyCytRxOncologyRegulationResearchUSA

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

20-01-2015

Fresenius Kabi, a unit of the Germany-headquartered Fresenius Group, has received approval from the US…

FreseniusFresenius Kabineostigmine methylsulfateNeurologicalPharmaceuticalRegulationUSA

Bayer's Xarelto gets label update in Europe

Bayer's Xarelto gets label update in Europe

20-01-2015

German drug major Bayer has updated the label for its Xarelto (rivaroxaban) in Europe.

BayerCardio-vascularGermanyPharmaceuticalRegulationXarelto

EMA to boost international cooperation on generics

EMA to boost international cooperation on generics

19-01-2015

The European Medicines Agency is ready to share its assessments of applications for generic medicines…

EuropeGenericsGlobalRegulation

Boehringer’s Ofev approved in EU for the treatment of IPF

19-01-2015

German family-owned pharma major Boehringer Ingelheim revealed today that the European Commission has…

Boehringer IngelheimEuropeOfevPharmaceuticalRegulationRespiratory and Pulmonary

Novartis’ Cosentyx gets third approval, now in Europe

19-01-2015

The European Commission (EC) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab, formerly…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulation

The first Sabin IPV approved by China FDA

19-01-2015

The China Food and Drug Administration (CFDA) on January 14 approved the production of the first inactivated…

ChinaPharmaceuticalProductionRegulationVaccines

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

18-01-2015

US biotech firm Celgene’s European subsidiary has received marketing authorization from the European…

Anti-Arthritics/RheumaticsBiotechnologyCelgene CorpDermatologicalsEuropeOtezlaRegulation

Akorn files ANDA for generic Durezol

16-01-2015

US generic drugmaker Akorn has confirmed that it has filed an Abbreviated New Drug Application (ANDA)…

AkornAlconDurezolGenericsNovartisOphthalmicsPatentsRegulationUSA

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

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