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FDA backs Janssen’s Sylvant for rare disease

24-04-2014

The US Food and Drug Administration yesterday approved Johnson & Johnson subsidiary Janssen Biotech’s…

Janssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRare diseasesRegulationsiltuximabSylvantUSA

US FDA clears pathway for Sarepta’s eteplirsen filing by year end

22-04-2014

US RNA-based drug developer Sarepta Therapeutics it plans to submit a New Drug Application to the US…

BiotechnologyeteplirsenNorth AmericaRare diseasesRegulationSarepta TherapeuticsUSA

Teva and Pfizer settle patent litigation over Celebrex

17-04-2014

Israel-based Teva Pharmaceutical Industries says that its US subsidiary has settled a law suit with US…

Anti-Arthritics/RheumaticsCelebrexGenericsNorth AmericaPatentsPfizerTeva Pharmaceutical IndustriesUSA

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

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

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

Express Scripts forecasts unsustainable increases in specialty drug spend in USA

Express Scripts forecasts unsustainable increases in specialty drug spend in USA

09-04-2014

Expensive treatments for broad patient populations are driving unprecedented growth in US spending on…

Anti-Arthritics/RheumaticsAnti-viralsMarkets & MarketingNorth AmericaOncologyPharmaceuticalPricingUSA

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

Amgen and GSK end marketing agreement for osteoporosis drug Prolia

Amgen and GSK end marketing agreement for osteoporosis drug Prolia

04-04-2014

World leading independent biotech firm Amgen revealed in a Securities and Exchange Commission filing…

AmgenAnti-Arthritics/RheumaticsBiotechnologyGlaxoSmithKlineLicensingProliaXgeva

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

Prasco to market the authorized generic of Lilly’s Evista in USA

01-04-2014

Privately-held US generics firm Prasco has signed a further deal with US pharma major Eli Lilly to market…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsMarkets & MarketingNorth AmericaPrasco LaboratoriesUSA

EMD Serono, Pfizer and Broad Institute link up on lupus research

EMD Serono, Pfizer and Broad Institute link up on lupus research

01-04-2014

EMD Serono, a US subsidiary of Germany’s Merck KGaA, has signed a research agreement with US pharma…

Anti-Arthritics/RheumaticsEMD SeronoMerck KGaAPfizerPharmaceuticalResearch

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

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

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

28-03-2014

Final draft guidance from the UK health care costs watchdog the National Institute for Health and Care…

Anti-Arthritics/RheumaticsJanssenJohnson & JohnsonNorthern EuropePharmaceuticalPricingRegulationStelara InjectionUK

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

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

Celgene’s Otezla is first oral therapy OKed by FDA for adults with active psoriatic arthritis

23-03-2014

The US Food and Drug Administration on Friday approved US biotech firm Celgene’s Otezla (apremilast),…

Anti-Arthritics/RheumaticsapremilastBiotechnologyCelgeneNorth AmericaOtezlaRegulationUSA

New survey confirms psoriasis and psoriatic arthritis patients frequently undertreated or not treated at all

21-03-2014

A unique and extensive survey provides the first-of-its-kind multinational look into the impact psoriasis…

Anti-Arthritics/RheumaticsCelgeneDermatologicalsHealthcarePharmaceutical

Latest Australian PBS Listings include medicines for children

Latest Australian PBS Listings include medicines for children

19-03-2014

Ten new medicines to treat a range of illnesses from rare forms of cancer to skin conditions will be…

Anti-Arthritics/RheumaticsAsia-PacificAustraliaDermatologicalsDiabetesGastro-intestinalsHealthcareOncologyPharmaceuticalPricing

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

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