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FDA approves Janssen’s Invokamet for diabetes

09-08-2014

The US Food and Drug Administration has approved US health care giant Johnson & Johnson subsidiary Janssen…

DiabetesInvokametInvokanaJanssenJohnson & JohnsonPharmaceuticalRegulationUSA

FDA fast tracks CTI BioPharma's pacritinib for myelofibrosis

FDA fast tracks CTI BioPharma's pacritinib for myelofibrosis

08-08-2014

US biotech firm CTI BioPharma (formerly called Cell Therapeutics) says that its pacritinib has been granted…

CTI BioPharmaOncologypacritinibPharmaceuticalRegulationUSA

Clinigen backs white paper calling for recognition of early access schemes

Clinigen backs white paper calling for recognition of early access schemes

08-08-2014

UK-based Clinigen Group has published a new International Society for Pharmaceutical Engineering (ISPE)…

Clinigen GroupHealthcarePharmaceuticalRegulationUKUnited States

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

08-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

DiabetesGerman Institute for Quality and EfficiencyGermanyNovo NordiskPharmaceuticalPricingRegulationTresiba

IQWiG finds no added benefit for Biogen Idec’s Tecfidera

IQWiG finds no added benefit for Biogen Idec’s Tecfidera

08-08-2014

In its early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG)…

Biogen IdecBiotechnologyGermanyMSNeurologicalPricingRegulationTecfidera

Europe to boost cooperation with international partners on generics

Europe to boost cooperation with international partners on generics

08-08-2014

The European Union’s decentralized procedure is being used as a model to accelerate the assessment…

EuropeEuropean UnionGenericsGlobalRegulation

NICE disappointed by Roche’s decision on Kadcyla pricing

NICE disappointed by Roche’s decision on Kadcyla pricing

08-08-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) said this morning…

Breast cancerCancerKadcylaNational Health ServiceOncologyPharmaceuticalPricingRegulationRocheUK

EU approval for Octapharma's Nuwiq across all age groups in hemophilia A

EU approval for Octapharma's Nuwiq across all age groups in hemophilia A

07-08-2014

The European Commission has approved independent Swiss biotech firm Octapharma's Nuwiq (simoctocog alfa)…

BiotechnologyEuropeHematologyNuwiqOctapharmaRegulation

Patient involvement pilot for orphan drugs launches in Canada

Patient involvement pilot for orphan drugs launches in Canada

07-08-2014

Canada’s Minister of Health, Rona Ambrose, says that the government has launched a pilot project targeting…

CanadaHealth CanadaPharmaceuticalRare diseasesRegulationResearchRocheTreatment of chronic lymphocytic leukemia

AusBiotech calls for greater culture of innovation and infrastructure in Australian Senate inquiry

AusBiotech calls for greater culture of innovation and infrastructure in Australian Senate inquiry

07-08-2014

AusBiotech, a body representing the biotechnology industry in Australia, has called for a greater culture…

AustraliaAustralian senateBiotechnologyBiotechnology industryRegulation

NICE comes back with different views on Tarceva and Iressa for NSCLC

NICE comes back with different views on Tarceva and Iressa for NSCLC

07-08-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is consulting again…

AstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

FDA approves The Medicines Company's Orbactiv for use in ABSSSIs

FDA approves The Medicines Company's Orbactiv for use in ABSSSIs

07-08-2014

The Food and Drug Administration has approved The Medicines Company’s Orbactiv (oritavancin) for injection…

Antibiotics and Infectious diseasesOrbactivoritavancinPharmaceuticalRegulationThe Medicines CompanyUSA

Cubist Pharmaceuticals voluntarily recalls Cubicin lots in the USA

Cubist Pharmaceuticals voluntarily recalls Cubicin lots in the USA

06-08-2014

American biopharmaceutical company Cubist has issued a voluntary recall of certain lots of Cubicin (daptomycin…

Antibiotics and Infectious diseasesBiotechnologyCubicinCubist PharmaceuticalsPhlebitisRegulationThromboembolismUSA

US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

New blood cancer injection given green light by UK regulators

New blood cancer injection given green light by UK regulators

05-08-2014

Patients in the UK with one of the most common forms of blood cancer can now benefit from a new injection.…

Andrew DaviesLymphomaMabTheraNHSOncologyPharmaceuticalRegulationRituximabRocheUK

Chiesi and uniQure delay Glybera launch to add data

Chiesi and uniQure delay Glybera launch to add data

04-08-2014

Netherlands-based venture capital backed human gene therapy firm uniQure and privately-held Italian drugmaker…

BiotechnologyChiesi FarmaceuticiEuropeGlyberaOrphan disease lipoprotein lipase deficiencyPricingRare diseasesRegulationuniQure

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