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The UK’s National Institute for Health and Care Excellence has issued new preliminary draft guidance…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

Medivir concludes Swedish agreement on Olysio-based treatment for hepatitis C

Medivir concludes Swedish agreement on Olysio-based treatment for hepatitis C

31-10-2014

Swedish drugmaker Medivir says it has entered into an agreement with Swedish county councils regarding…

Anti-viralsJanssenJohnson & JohnsonMedivirOlysioPharmaceuticalPricingRegulationSweden

US biopharma groups oppose drug disposal ordinance

US biopharma groups oppose drug disposal ordinance

31-10-2014

A coalition of five USA-based health care and drug manufacturing advocacy organizations yesterday expressed…

HealthcarePharmaceuticalRegulationUSA

NICE recommends Pradaxa for DVT and PE

NICE recommends Pradaxa for DVT and PE

31-10-2014

In draft guidance published today, the UK health costs watchdog the National Institute for Health and…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaPricingRegulationUK

US FDA approves AstraZeneca’s Xigduo XR

US FDA approves AstraZeneca’s Xigduo XR

30-10-2014

The US Food and Drug Administration has approved Anglo-Swedish pharma major AstraZeneca’s once-daily…

AstraZenecaDiabetesPharmaceuticalRegulationUSAXigduo XR

EMA guidance on facilitating global development of biosimilars

EMA guidance on facilitating global development of biosimilars

30-10-2014

The European Medicines Agency has published its revised overarching guideline on biosimilars, or follow-on…

BiosimilarsBiotechnologyEuropeRegulation

Russian Parliament to restrict imports of unregistered drugs

30-10-2014

The Russian National Parliament (State Duma) plans to impose a ban on the imports of unregistered drugs…

PharmaceuticalPoliticsRegulationRussia

US FDA approves first vaccine to prevent serogroup B meningococcal disease

30-10-2014

The US Food and Drug Administration yesterday granted accelerated approval for pharma major Pfizer’s…

PfizerPharmaceuticalRegulationTrumenbaUSAVaccines

EMA advises GlaxoSmithKline on Ebola vaccine development

29-10-2014

The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development…

Anti-viralsGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

Polish and European generics groups view opportunities for biosimilars

29-10-2014

The European Biosimilars Group – a sector group of the European Generic medicines Association, together…

BiosimilarsEastern EuropeGenericsMarkets & MarketingPolandPricingRegulation

PBS means Australian patients and government are paying less for products

PBS means Australian patients and government are paying less for products

29-10-2014

Australian patients continue to pay less for medicines due to a notable rise in the number of prescriptions…

AustraliaPharmaceuticalPharmaceutical sciencesPharmacologyRegulation

Russian approval for Norgine/Takeda’s MoviPrep

28-10-2014

Netherlands-headquartered independent drugmaker Norgine says that its partner, Japan’s largest pharma…

Gastro-intestinalsMoviPrepNorginePharmaceuticalRegulationRussiaTakeda Pharmaceutical

Sarepta receives new FDA guidance on data needed for eteplirsen's NDA in Duchenne Muscular Dystrophy

Sarepta receives new FDA guidance on data needed for eteplirsen's NDA in Duchenne Muscular Dystrophy

28-10-2014

Rare and infectious disease specialist Sarepta provided an update on its discussions with the US Food…

CNS DiseaseseteplirsenPharmaceuticalRegulationSarepta TherapeuticsUSA

Merck & Co third-qtr disappoints, as earnings plunge

Merck & Co third-qtr disappoints, as earnings plunge

27-10-2014

US pharma giant Merck & Co (NYSE: MRK) posted third-quarter 2014 financial results today, showing that…

FinancialKeytrudaMerck & CoOncologyPharmaceuticalRegulationUSA

EuropaBio’s new White Paper 'Realising the Potential of Personalized Medicine in Europe'

27-10-2014

Biotechnology trade group EuropaBio has issued a new White Paper, aiming to identify the required adaptations…

BiotechnologyEuropeRegulationResearch

Hikma shares slide as FDA issues warning letter over its Portugal injectables plant

Hikma shares slide as FDA issues warning letter over its Portugal injectables plant

27-10-2014

Jordanian drugmaker Hikma has seen its shares fall as a result of a warning from the US Food and Drug…

Hikma PharmaceuticalsHospiraPharmaceuticalPortugalRegulation

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