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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

Celgene’s Otezla misses endpoint in Ph III ankylosing spondylitis study

Celgene’s Otezla misses endpoint in Ph III ankylosing spondylitis study

09-07-2014

Shares of US biotech firm Celgene fell 3.5% in premarket trade, but were up 1.2% $86.75 by mid-morning…

Anti-Arthritics/RheumaticsBiotechnologyCelgeneOtezlaResearchUSA

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

European Generic Medicines Association speaks out against EC’s perindopril decision

European Generic Medicines Association speaks out against EC’s perindopril decision

09-07-2014

The European Generic Medicines Association (EGA) has expressed concerns over the European Commission’s…

Cardio-vascularEuropeGenericsLegalLupinperindoprilServierunichem

Nuevolution names Paul Workman as scientific advisor

Nuevolution names Paul Workman as scientific advisor

09-07-2014

Biochemist and cancer pharmacologist Paul Workman has joined Copenhagen-based pharmaceutical company…

BoardroomDenmarkNuevolutionPaul Workman

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

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

09-07-2014

The US Food and Drug Administration has approved privately-held US biotech firm Protein Sciences’ strain…

BiotechnologyFlublokInfluenzaProtein Sciences CorpRegulationUSAVaccines

Acorda fights Actavis on generic of its multiple sclerosis drug Ampyra

Acorda fights Actavis on generic of its multiple sclerosis drug Ampyra

09-07-2014

Ireland-headquartered generics major Actavis has confirmed filing an Abbreviated New Drug Application…

Acorda TherapeuticsActavisAmpyradalfampridineGenericsLegalNeurologicalUSA

England’s community prescribing rises almost 60% but costs increase only 15% in 10 years

England’s community prescribing rises almost 60% but costs increase only 15% in 10 years

09-07-2014

The number of prescription items dispensed in the community in England has increased by 58.5% over 10…

atorvastatinHealthcareLipitorPfizerPharmaceuticalUK

Salix Pharma to combine with unit of Italy’s Cosmo

Salix Pharma to combine with unit of Italy’s Cosmo

09-07-2014

US drugmaker Salix Pharmaceuticals has agreed to combine with an Ireland-based unit of Italy’s Cosmo…

Cosmo PharmaceuticalsCosmo TechnologiesGastro-intestinalsMergers & AcquisitionsPharmaceuticalSalix Pharmaceuticals

AbbVie comes up with higher offer for Shire of $51.5 billion

AbbVie comes up with higher offer for Shire of $51.5 billion

08-07-2014

As has been widely expected following the meetings last week with major shareholders of Ireland headquartered…

AbbVieMergers & AcquisitionsPharmaceuticalShire

Swissmedic approves Amitiza for opioid-induced constipation

Swissmedic approves Amitiza for opioid-induced constipation

08-07-2014

US biopharma firm Sucampo Pharmaceuticals has received approval from Swissmedic, Switzerland’s Agency…

AmitizaEuropeGastro-intestinalsPharmaceuticalRegulationSucampo

Mylan launches generic Micardis in USA

Mylan launches generic Micardis in USA

08-07-2014

US generic drugmaker Mylan has launched Telmisartan Tablets USP, 20mg, 40mg and 80mg, the generic version…

Boehringer IngelheimCardio-vascularGenericsMarkets & MarketingMicardisMylanRegulationTelmisartanUSA

French pharma trade group teams up with police to counter fake medicine

French pharma trade group teams up with police to counter fake medicine

08-07-2014

The French pharmaceutical trade group Les Entreprises du Medicament (Leem) has joined forces with a police…

FranceLegalPharmaceutical

China’s Yabao Pharma partners with Eli Lilly to develop diabetes candidate

China’s Yabao Pharma partners with Eli Lilly to develop diabetes candidate

08-07-2014

Chinese drugmaker Yabao Pharmaceutical has entered a strategic partnership with US pharma major Eli Lilly…

ChinaDiabetesEli LillyLicensingPharmaceuticalYabao Pharmaceutical

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