Pharmaceutical - Antibiotics and Infectious diseases, Rare diseases

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FDA grants "Breakthrough Therapy" status for Alexion's asfotase in HPP; issues CRL for Valeant's efinaconazole

28-05-2013

US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) says that the Food and Drug Administration has granted…

Alexion PharmaceuticalsAntibiotics and Infectious diseasesasfotase alfaefinaconazoleNorth AmericaPharmaceuticalRare diseasesRegulationValeant Pharmaceuticals

Preliminary NICE guidance negative on Pfizer's Xalkori for lung cancer; backs Colobreathe and Tobi Podhaler for CF

27-03-2013

Much to the disappointment of the company, this morning (March 27), UK drugs watchdog the National Institute…

Antibiotics and Infectious diseasesColoBreatheEuropeForest LaboratoriesNovartisOncologyPfizerPharmaceuticalPricingRare diseasesRegulationTobi PodhalerXalkori

NICE "green light" for Novartis' Tobi Podhaler and Forest's Colobreathe

24-01-2013

The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in a final draft…

Antibiotics and Infectious diseasesColoBreatheEuropeForest LaboratoriesNovartisPharmaceuticalPricingRare diseasesRegulationTobi Podhaler

US FDA approvals for Signifor, raxibacumab and Iclusig

17-12-2012

In a flurry of activity from the US Food and Drug Administration on Friday, the agency - which looks…

Antibiotics and Infectious diseasesAriad PharmaceuticalsGlaxoSmithKlineIclusigNorth AmericaNovartisOncologyPharmaceuticalRare diseasesraxibacumabRegulationSignifor

GlaxoSmithKline amends accord with Isis Pharma; gets FDA panel backing for raxibacumab

06-11-2012

USA-based Isis Pharmaceuticals (Nasdaq: ISIS) says it has agreed to amend the clinical development plan…

Antibiotics and Infectious diseasesBiotechnologyFinancialGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR.RXLicensingNorth AmericaPharmaceuticalRare diseasesraxibacumabRegulationResearch

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