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Sanofi Pasteur’s Quadracel vaccine gets FDA approval

26-03-2015

French pharma major Sanofi’s (Euronext: SAN) Sanofi Pasteur has received approval from the US Food…

PharmaceuticalQuadracelRegulationSanofiSanofi PasteurUSAVaccines

FDA approval for Emergent BioSolutions’ Anthrasil

25-03-2015

US biopharma company Emergent BioSolutions has received approval from the US Food and Drug Administration…

AnthrasilAntibiotics and Infectious diseasesEmergent BioSolutionsPharmaceuticalRegulationUSA

European Commission approves Santen Pharma’s Ikervis for eye disease

25-03-2015

Japanese drugmaker Santen Pharmaceutical has received approval of the Marketing Authorization Application…

EuropeIkervisOphthalmicsPharmaceuticalRegulationSanten Pharmaceuticals

Ono Pharma gets South Korea approval of Opdivo

24-03-2015

Japanese drugmaker Ono Pharmaceutical has received approval from South Korea’s Ministry of Food and…

BiotechnologyBristol-Myers SquibbOncologyOno PharmaceuticalOpdivoRegulationSouth Korea

FDA safety review of Zyprexa Relprevv calls for no changes to current prescribing

24-03-2015

The US Food and Drug Administration has concluded a review of a study undertaken to determine the cause…

Eli LillyHealthcareNeurologicalPharmaceuticalRegulationUSAZyprexa Relprevv

Regenerative Medicine Expert Group publishes report with action plan for UK implementation

Regenerative Medicine Expert Group publishes report with action plan for UK implementation

24-03-2015

The Regenerative Medicine Expert Group has published its report ‘Building on our own potential: a UK…

BiotechnologyPricingRegulationResearchUK

Novo Nordisk’s Saxenda gains EU approval for obesity

24-03-2015

There was good news for Danish diabetes care giant Novo Nordisk yesterday, when, late in the day, the…

DiabetesEuropeMetabolicsNovo NordiskPharmaceuticalRegulationSaxendaVictoza

Pfizer and Lilly gear up to resume Phase III chronic pain program for tanezumab

23-03-2015

US pharma majors Pfizer and Eli Lilly both saw their shares rise in pre-market trading today, as they…

Eli LillyLicensingNeurologicalPfizerPharmaceuticalRegulationUSA

Pfenex gets early HSR clearance for collaboration with Hospira

23-03-2015

The US Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino…

BiosimilarsBiotechnologyGenentechHospiraLicensingLucentisOphthalmicsPF582PfenexRegulationRocheUSA

Ukranian pharma organization APRaD meets with European bodies on domestic health reform

Ukranian pharma organization APRaD meets with European bodies on domestic health reform

23-03-2015

The Ukrainian pharma organization, the Association of Pharmaceutical Research and Development (APRaD)…

BrusselsPharmaceuticalPoliticsRegulationUkraine

IQWiG now finds added benefit for Provenge

23-03-2015

Reversing a previous negative opinion, the German Institute for Quality and Efficiency in Health Care…

BiotechnologyDendreonGermanyOncologyPricingProvengeRegulationValeant Pharmaceutical International

Farmaindustria defends the non-interchangeability principle for biologic and biosimilar medicines

21-03-2015

Speaking at the first Biological Medicines Forum organized by the Associations last week, the president…

BiosimilarsBiotechnologyPatents & Trade marksRegulationSpain

Aurobindo gains tentative US FDA approval for generic Vimpat

21-03-2015

Indian drugmaker Aurobindo Pharma has received tentative approval from the US Food and Drug Administration…

Aurobindo PharmaGenericslacosamide Tablet and InjectionLegalNeurologicalRegulationUCBUSAVimpat

Amgen files for Repatha approval in Japan

20-03-2015

Leading USA-based biotech firm Amgen has filed for approval of Repatha (evolocumab) for the treatment…

AmgenAstellas PharmaBiotechnologyCardio-vascularevolocumabJapanRegulationRepatha

Dilaforette's sevuparin granted orphan drug designation by FDA in sickle-cell disease

Dilaforette's sevuparin granted orphan drug designation by FDA in sickle-cell disease

20-03-2015

Dilaforette, a portfolio company of Karolinska Development, a Nordic investor in life sciences, has been…

DilaforetteHematologyPharmaceuticalRegulationResearchSevuparinSwedenUSA

Compliance at home and in emerging markets the key challenges to pharma, says study

Compliance at home and in emerging markets the key challenges to pharma, says study

20-03-2015

The UK pharma sector expects one of its biggest challenges to be the risk of incurring fines as they…

Markets & MarketingPharmaceuticalProductionRegulationUK

Mixed FDA advisory panel views on GSK’s Breo Ellipta

20-03-2015

There was conflicting news yesterday for UK pharma major GlaxoSmithKline and US partner Theravance from…

Breo ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and Pulmonary

Amicus has positive meeting with EMA and FDA to accelerate approval of Fabry monotherapy

Amicus has positive meeting with EMA and FDA to accelerate approval of Fabry monotherapy

19-03-2015

Amicus Therapeutics has had positive meetings with regulatory authorities in Europe and the USA to discuss…

Amicus TherapeuticsBiotechnologyEuropemigalastatRare diseasesRegulationUSA

FDA grants Nicox orphan drug designation for naproxcinod in Duchenne muscular dystrophy

FDA grants Nicox orphan drug designation for naproxcinod in Duchenne muscular dystrophy

19-03-2015

French ophthalmic specialist Nicox has been granted orphan drug designation by the US Food and Drug Administration…

GeneticsnaproxcinodNicOxNicOxRegulation

FDA approval for Vertex’ Kalydeco for very young children

18-03-2015

There was good news for US biotech firm Vertex Pharmaceuticals yesterday, when the US Food and Drug Administration…

BiotechnologyKalydecoRare diseasesRegulationUSAVertex Pharmaceuticals

Research from IQWiG shows early benefit assessment increases trial data transparency

Research from IQWiG shows early benefit assessment increases trial data transparency

18-03-2015

Research from the German Institute for Quality and Efficiency in Healthcare (IQWiG) published in the…

Efficiency in HealthcareGermanyPharmaceuticalPharmacologyRegulation

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