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Canadian approval for GSK’s Incruse Ellipta as a treatment for COPD

17-04-2014

UK pharma giant GlaxoSmithKline says that Incruse Ellipta (umeclidinium) has received market authorization…

CanadaGlaxoSmithKlineIncruse ElliptaNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

2014 “drugs to watch” as potential blockbusters

2014 “drugs to watch” as potential blockbusters

17-04-2014

The Thomson Reuters Intellectual Property & Science business has released its annual forecast of the…

AfrezzaAnoro ElliptaAnti-viralsCyramzaEli LillyGilead SciencesGlaxoSmithKlineidelalisibMannKindMarkets & MarketingOncologyPharmaceuticalRespiratory and PulmonarySovaldi

BioAlliance Pharma and Topotarget merge to create leader in orphan oncology diseases

BioAlliance Pharma and Topotarget merge to create leader in orphan oncology diseases

16-04-2014

French orphan drug developer BioAlliance Pharma and Denmark’s Topotarget today announced their intention…

belinostatBioAlliance PharmaLivatagMergers & AcquisitionsOncologyPharmaceuticalRare diseasesTopotarget

OxThera gains $10 million investment to continue Phase II trial

16-04-2014

Shareholders of privately-held Swedish biopharmaceutical company OxThera have agreed with a syndicate…

BiopharmaceuticalFinancialKidney diseasesOxabactOxTheraPharmaceuticalPrimary hyperoxaluriaRare diseasesRemi DrollerSweden

Prosonix and Mylan in deal for Flixotide and Flovent generics

15-04-2014

Prosonix, a UK-based company which is developing a portfolio of inhaled “Respiratory Medicines by Design,”…

FloventGenericsGlaxoSmithKlineGlobalLicensingMylan LaboratoriesProsonixRespiratory and Pulmonary

Negative results for asthma candidate cause Cytos Biotech to look at liquidation

14-04-2014

Swiss drug developer Cytos Biotechnology today revealed that the Phase IIb study of CYT003 in patients…

BiotechnologyFinancialResearchRespiratory and Pulmonary

Extended US market exclusivity for BioMarin's rare disease drug Kuvan

14-04-2014

US drugmaker BioMarin Pharmaceutical says that the Food and Drug Administration has granted Kuvan (sapropterin…

BioMarin PharmaceuticalKuvanNorth AmericaPharmaceuticalRare diseasesRegulationUSA

GSK faces bribery allegations in Poland

GSK faces bribery allegations in Poland

14-04-2014

UK pharma major GlaxoSmithKline is facing allegations of bribing doctors in Poland, according to the…

BBCGlaxoSmithKlineGSK regional managerLegalMajorMedicinePharmaceuticalPolandPulmonologyRespiratory and PulmonarySeretideUK

Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

Australia to review program for life-saving drugs access

Australia to review program for life-saving drugs access

10-04-2014

The Australian government says that it will review the Life Saving Drugs Program (LSDP) - a move aimed…

Asia-PacificAustraliaFinancialHealthcarePharmaceuticalRare diseases

Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

09-04-2014

US drugmaker Forest Laboratories and partner Almirall, Spain’s largest pharma company, say they have…

aclidiniumAlmirallForest LaboratoriesformoterolNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryUSA

Promoting competition key to improving patients’ access to high cost medicines, says PHARMAC

Promoting competition key to improving patients’ access to high cost medicines, says PHARMAC

08-04-2014

New Zealand’s Pharmaceutical Management Agency, PHARMAC, has announced its intention to test out a…

Asia-PacificFinancialHealthcareNew ZealandPharmaceuticalRare diseases

EMA and Australia’s TGA collaborate in the area of orphan medicines

EMA and Australia’s TGA collaborate in the area of orphan medicines

07-04-2014

During a meeting last week at the European Medicines Agency, the EMA’s executive director, Guido Rasi,…

AustraliaEuropePharmaceuticalRare diseasesRegulation

UCB enters strategic alliance with Weill-Cornell in three discovery projects

03-04-2014

Belgian drugmaker UCB has launched a major, three-year strategic research alliance with Weill-Cornell…

MetabolicsPharmaceuticalRare diseasesResearchUCB

SOBI assumes direct responsibility for rare disease drug Orfadin in the USA and Canada

SOBI assumes direct responsibility for rare disease drug Orfadin in the USA and Canada

01-04-2014

Biotech firm Swedish Orphan Biovitrum has assumed direct responsibility for the distribution of its proprietary…

BiotechnologyMarkets & MarketingNorthern EuropeOrfadinRare diseasesSobi

Bayer’s Adempas gains EU clearance for two forms of PAH

Bayer’s Adempas gains EU clearance for two forms of PAH

31-03-2014

Following a previous positive opinion from the European Medicines Agency’s advisory committee, the…

AdempasBayerEuropePharmaceuticalRegulationRespiratory and Pulmonary

Jazz Pharma and Gentium debut Defitelio in Europe

31-03-2014

Ireland-headquartered Jazz Pharmaceuticals and its Italian subsidiary Gentium have initiated the European…

AustriaDefitelioEuropeGentiumGermanyJazz PharmaceuticalsMarkets & MarketingPharmaceuticalRare diseases

Insmed’s mixed results from Ph II trial for treatment resistant NTM lung infections

27-03-2014

US-based Insmed has reported mixed results from its Phase II clinical trial of Arikayce, for the treatment…

Inflammatory diseasesInsmedPharmaceuticalRegulationRespiratory and PulmonaryUSA

Breakthrough therapies for rare diseases command premium pricing

Breakthrough therapies for rare diseases command premium pricing

26-03-2014

The global orphan drugs market presents plenty of opportunities for new drug development – while there…

PharmaceuticalPricingRare diseasesResearch

US District Court upholds Mylan's US patents on Perforomist Inhalation Solution

25-03-2014

US generics major Mylan says the US District Court for the Northern District of West Virginia issued…

GenericsLegalMylan LaboratoriesNorth AmericaPatentsPerforomistRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

Promising mid-stage results for Prosensa’s drisapersen in DMD boys

19-03-2014

Shares of Dutch biotech firm Prosensa Holding rose 3.85% to $7.02 after the firm reported encouraging…

BiotechnologydrisapersenGlaxoSmithKlineProsensaRare diseasesResearch

More positive Ph III data for Amgen’s evolocumab

More positive Ph III data for Amgen’s evolocumab

17-03-2014

Leading independent biotech firm Amgen has released more positive clinical trial data with its cholesterol…

AmgenBiotechnologyCardio-vascularevolocumabRare diseasesResearch

Actelion says COMPASS-2 bosentan study fails primary endpoint

Actelion says COMPASS-2 bosentan study fails primary endpoint

17-03-2014

Europe’s largest biotech company Actelion has announced disappointing results of COMPASS-2, a Phase…

ActelionBiotechnologybosentanPfizerResearchRespiratory and PulmonarysildenafilTracleer

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