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Positive draft guidance for hep C drug Sovaldi from UK’s NICE

Positive draft guidance for hep C drug Sovaldi from UK’s NICE

15-08-2014

In further draft guidance published today, UK drugs watchdog the National Institute for Health and Care…

Anti-viralsBiotechnologyGilead SciencesHepatitis CPricingRegulationRibavirinSovaldiUK

NICE says benefit of prostate cancer drug Zytiga does not justify price

NICE says benefit of prostate cancer drug Zytiga does not justify price

15-08-2014

The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Zytiga (abiraterone)…

AbirateroneAndrew DillonJanssenOncologyPharmaceuticalRegulationUKZytiga

Alexza updates on the five post-EMA approval studies for Adasuve

Alexza updates on the five post-EMA approval studies for Adasuve

14-08-2014

US drugmaker Alexza Pharmaceuticals has provided an update on its European Medicines Agency post-approval…

AdasuveAlexza PharmaceuticalEuropeNeurologicalPharmaceuticalPiperazinesPsychiatryRegulationResearch

Merck’s Belsomra gets FDA approval for insomnia

Merck’s Belsomra gets FDA approval for insomnia

14-08-2014

Pharma giant Merck & Co has received US Food and Drug Administration approval for its insomnia treatment…

BelsomraMerck & CoNeurologicalPharmaceuticalRegulationSedativesUSA

Asia Healthcare Forum identifies challenges ahead for meetings in the sector

Asia Healthcare Forum identifies challenges ahead for meetings in the sector

13-08-2014

The inaugural Healthcare Meetings Forum Asia was over-subscribed on August 1 at Suntec Singapore, an…

Asia-PacificMarkets & MarketingPharmaceuticalRegulationSingapore

Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

13-08-2014

“The National Institute for Health and Care Excellence’s recent rejection of Kadcyla, Roche’s latest…

KadcylaOncologyPharmaceuticalPricingRegulationRocheUK

Insys submits Dronabinol oral solution New Drug Application

Insys submits Dronabinol oral solution New Drug Application

13-08-2014

Supportive care specialist Insys Therapeutics has made a New Drug Application submission to the US Food…

CannabinoidsDronabinolEntheogensGastro-intestinalsInsys TherapeuticsPharmaceuticalRegulationTetrahydrocannabinolUSA

Medicines New Zealand updates its code of practice to cover social media

Medicines New Zealand updates its code of practice to cover social media

13-08-2014

New Zealand's pharmaceutical industry association, Medicines New Zealand, has updated its Code of Practice…

New ZealandPharmaceuticalPharmaceuticals policyPharmacologyRegulation

Belgian pharma trade body issues recommendations on domestic drug shortages

Belgian pharma trade body issues recommendations on domestic drug shortages

11-08-2014

Belgium’s pharmaceutical trade body, pharma.be, has issued a conclusion of its report on the shortage…

BelgiumMarkets & MarketingPharmaceuticalRegulation

Eylea approved for diabetic macular edema in Europe

Eylea approved for diabetic macular edema in Europe

11-08-2014

The European Commission has approved German pharma major Bayer’s Eylea (aflibercept) injection for…

BayerEuropeEyleaOphthalmicsOphthalmologyPharmaceuticalRegeneronRegulation

FDA issues new biosimilars guidance on exclusivity

FDA issues new biosimilars guidance on exclusivity

11-08-2014

The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…

BiosimilarsBiotechnologyFinancialRegulationUSA

Genentech files sBLA for Lucentis for diabetic retinopathy

09-08-2014

Genentech, the biotech subsidiary of Swiss pharma major Roche, has submitted a supplemental Biologics…

BiotechnologyGenentechLucentisOphthalmicsRegulationRocheUSA

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

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