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US drug approvals lower than previously reported; new study

10-01-2014

The overall success rate for drugs moving through clinical trials to US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearchUSA

Japan to investigate Novartis promotion of Diovan; US allegation over Exjade

Japan to investigate Novartis promotion of Diovan; US allegation over Exjade

10-01-2014

Swiss drug major Novartis faced two problems yesterday, when the Japanese Ministry of Health Labor and…

Asia-PacificCardio-vascularDiovanExjadeHematologyLegalMarkets & MarketingNorth AmericaNovartisPharmaceuticalUSA

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

09-01-2014

Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday approved Anglo-Swedish…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesFarxigaNorth AmericaPharmaceuticalRegulationUSA

Drug company success depends on new development paradigms, says Tufts CSDD

08-01-2014

While many drug developers continue to improve clinical trial operational efficiency to increase the…

LicensingNorth AmericaPharmaceuticalResearch

US national health spending growth remains low for 4th consecutive year

07-01-2014

Overall national health expenditures in the USA grew at an annual rate of 3.7% in 2012, marking the fourth…

FinancialGenericsHealthcareNorth AmericaPharmaceuticalUSA

Six US research institutions get $540 million funding from Ludwig Cancer Research

06-01-2014

Cancer research in the US received a critical boost as the six Ludwig Centers at Johns Hopkins University,…

FinancialNorth AmericaOncologyPharmaceuticalResearchUSA

Eisai’s epilepsy drug Fycompa to launch in USA

Eisai’s epilepsy drug Fycompa to launch in USA

02-01-2014

The US subsidiary of Japanese pharma major Eisai’s that its epilepsy drug Fycompa (perampanel) will…

EisaiFycompaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalUSA

US global share of biomedical research spending declines, as Asia gains

02-01-2014

The USA’s global share of biomedical research spending fell from 51% in 2007 to 45% in 2012, while…

Asia-PacificChinaFinancialNorth AmericaPharmaceuticalRegulationResearchUSA

Canadian Rx atlas maps billions in pharma savings – for now

Canadian Rx atlas maps billions in pharma savings – for now

02-01-2014

Canadians are spending less on prescription drugs for the first time since World War II, according to…

CanadaFinancialHealthcareNorth AmericaPharmaceutical

Joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing now in effect

01-01-2014

The European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research…

EuropeNorth AmericaPharmaceuticalResearchUSA

Cubist’s tedizolid NDA accepted for priority review in USA

Cubist’s tedizolid NDA accepted for priority review in USA

31-12-2013

The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ New Drug Application for its…

Antibiotics and Infectious diseasesBayerCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationtedizolidTrius TherapeuticsUSA

Veloxis Pharma submits NDA for Envarsus in kidney transplant recipients

30-12-2013

Denmark’s Veloxis Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration…

EnvarsusImmunologicalsLCP-TacroNorth AmericaPharmaceuticalRegulationUSAVeloxis Pharmaceuticals

US FDA calls for more trials on Genzyme’s Lemtrada

US FDA calls for more trials on Genzyme’s Lemtrada

30-12-2013

There was a significant disappointment this morning for French drug major Sanofi, when it revealed that…

BayerGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofiUSA

Abbott Labs pays $5.5 million to settle claims it paid kickbacks to US physicians

Abbott Labs pays $5.5 million to settle claims it paid kickbacks to US physicians

29-12-2013

US drugmaker Abbott Laboratories has agreed to pay $5.475 million to resolve allegations that it violated…

LegalMarkets & MarketingNorth AmericaPharmaceuticalUSA

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

27-12-2013

Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development…

DiabetesfasiglifamGastro-intestinalsNorth AmericaPharmaceuticalRegulationResearchTakeda PharmaceuticalsUSAvedolizumab

Everett Labs acquires Quinnova Pharma to diversify US market presence

27-12-2013

US specialty pharma firm Everett Laboratories, a subsidiary of Spain’s Exeltis, has acquired Quinnova…

Amneal EnterprisesDermatologicalsEverett LaboratoriesExeltisMergers & AcquisitionsNorth AmericaPharmaceuticalQuinnova PharmaceuticalsUSAWomen's Health

FDA approves Novo Nordisk’s Tretten to treat rare genetic clotting disorder

FDA approves Novo Nordisk’s Tretten to treat rare genetic clotting disorder

24-12-2013

The US Food and Drug Administration yesterday (December 23) approved Tretten, coagulation factor XIII…

HematologyNorth AmericaNovo NordiskNovoThirteenPharmaceuticalRare diseasesRegulationTretten

FDA clears resumption of Iclusig sales in USA

FDA clears resumption of Iclusig sales in USA

22-12-2013

The US Food and Drug Administration has approved a revised US Prescribing Information and a Risk Evaluation…

North AmericaOncologyPharmaceuticalRegulation

Novo Nordisk files for approval of high strength liraglutide for obesity

Novo Nordisk files for approval of high strength liraglutide for obesity

22-12-2013

Danish insulin giant Novo Nordisk has filed separate regulatory submissions with the US Food and Drug…

DiabetesEuropeliraglutideMetabolicsNorth AmericaNovo NordiskPharmaceuticalRegulationVictoza

FDA “Breakthrough Therapy” designation for GSK’s malaria drug tafenoquine; EU Cervarix news

FDA “Breakthrough Therapy” designation for GSK’s malaria drug tafenoquine; EU Cervarix news

22-12-2013

The US Food and Drug Administration has granted “Breakthrough Therapy” designation for tafenoquine,…

CervarixEuropeGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationtafenoquineTropical diseases

Forest debuts MMD drug Fetzima in US pharmacies

19-12-2013

US drugmaker Forest Laboratories says that Fetzima (levomilnacipran ER capsules) is now available in…

FetzimaForest LaboratoriesMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalPierre FabreUSA

Alimera says FDA advisory committee on Iluvien no longer necessary

Alimera says FDA advisory committee on Iluvien no longer necessary

19-12-2013

US ophthalmic pharma specialist Alimera Sciences has entered into labeling discussions with the US Food…

Alimera SciencesIluvienNorth AmericaOphthalmicsPharmaceuticalpSividaRegulation

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

19-12-2013

The US Food and Drug Administration late yesterday approved Anoro Ellipta (umeclidinium and vilanterol…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

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