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Bristol-Myers to file Opdivo BLA earlier than expected

Bristol-Myers to file Opdivo BLA earlier than expected

10-07-2014

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third…

Bristol-Myers SquibbnivolumabOncologyOpdivoPharmaceuticalRegulationUSA

Orphan drug approvals rise, but high costs pose challenges for patients

Orphan drug approvals rise, but high costs pose challenges for patients

10-07-2014

Although the pace of approvals for new orphan drugs - medicines that treat relatively rare conditions…

EuropePharmaceuticalPricingRare diseasesRegulationUSA

M3 launches messaging service to improve pharma engagement with doctors

M3 launches messaging service to improve pharma engagement with doctors

10-07-2014

M3 has announced the launch of a new messaging service on Doctors.net.uk, aiming to enable pharmaceutical…

Doctors.net.HealthcarePharmaceuticalPharmaceutical industryPharmacologyUK

EU orphan designations for OPKO's clotting Factor VIIa-CTP

EU orphan designations for OPKO's clotting Factor VIIa-CTP

10-07-2014

The European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the…

EuropeFactor VIIa-CTPHematologyOPKO HealthPharmaceuticalRare diseasesRegulation

A$35 million to advance Australian type 1 juvenile diabetes research

A$35 million to advance Australian type 1 juvenile diabetes research

10-07-2014

Australia’s Minister for Education, Christopher Pyne, and Minister for Health, Peter Dutton, have today…

AustraliaDiabetesFinancialPharmaceuticalResearch

Stada Arz acquires Flexitol rights for UK and Ireland

Stada Arz acquires Flexitol rights for UK and Ireland

10-07-2014

Thornton & Ross, the UK subsidiary of German generic and branded drugmaker Stada Arzneimittel, has purchased…

DermatologicalsFlexitolIrelandMergers & AcquisitionsPharmaceuticalSTADA ArzneimittelThornton & RossUK

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

10-07-2014

Researchers have highlighted a flaw in the US Food and Drug Administration’s approval process for attention…

Kenneth MandlNeurologicalPharmaceuticalPharmacologyPharmacovigilanceRegulationRitalinUSA

Proveca reaches agreement with EMA over heart failure drug for children

Proveca reaches agreement with EMA over heart failure drug for children

10-07-2014

UK pharmaceutical company Proveca has reached its fourth key agreement with the European Medicines Agency…

CaptoprilCardio-vascularPharmaceuticalRegulationUK

UK’s NICE backs Lundbeck drug for alcohol dependence

UK’s NICE backs Lundbeck drug for alcohol dependence

10-07-2014

In new draft guidance, the UK drug watchdog the National Institute for Health and Care Excellence (NICE)…

LundbeckNeurologicalPharmaceuticalPricingRegulationSelincroUK

Novartis’ secukinumab significantly more effective in psoriasis than NICE-recommended equivalent

Novartis’ secukinumab significantly more effective in psoriasis than NICE-recommended equivalent

10-07-2014

Data published in the New England Journal of Medicine has shown secukinumab to be more effective at treating…

DermatologicalsetanerceptNovartisPharmaceuticalPsoriasisResearchsecukinumabUSA

EMA delays formal adoption of publication of clinical trial data policy

EMA delays formal adoption of publication of clinical trial data policy

10-07-2014

The European Medicines Agency management board has postponed formal adoption of the policy on publication…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalRegulationResearch

France adopts draft law on off-label use of drugs

France adopts draft law on off-label use of drugs

09-07-2014

The French National Assembly yesterday voted on the draft law proposal, which would potentially allow…

AvastinDraft law proposalEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

MabVax Therapeutics and Telik close merger

MabVax Therapeutics and Telik close merger

09-07-2014

USA-based MabVax Therapeutics, a privately held cancer immunotherapy company, and Telik, a publicly-traded…

MabVax TherapeuticsMergers & AcquisitionsOncologyPharmaceuticalTelikUSA

Drug sales up in Brazil while generics take greater market share

09-07-2014

Sales of medicines in Brazil have increased 13% compared to last year, writes Juliane Carvalho of Brazil…

BrazilMarkets & MarketingPharmaceutical

Novo Nordisk gains FDA backing for new NovoSeven RT indication

Novo Nordisk gains FDA backing for new NovoSeven RT indication

09-07-2014

Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa…

HematologyNovo NordiskNovoSevenNovoSeven RTPharmaceuticalRare diseasesRegulationUSA

New Zealand proposes contestable fund for medicines for rare disorders

New Zealand proposes contestable fund for medicines for rare disorders

09-07-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC will be running a commercial process to fund…

FinancialNew ZealandPharmaceuticalRare diseasesRegulation

Varenicline combined with nicotine patch improves smoking cessation rates

Varenicline combined with nicotine patch improves smoking cessation rates

09-07-2014

Combining the smoking cessation medication varenicline with nicotine replacement therapy was more effective…

ChantixNeurologicalNicotinePfizerPharmaceuticalResearchSmoking cessationUSAVarenicline

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