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Shire confirms it has entered into talks with AbbVie

Shire confirms it has entered into talks with AbbVie

12-07-2014

Following reports by the Bloomberg news service, on Friday Ireland-based drugmaker Shire confirmed that…

AbbVieIrelandMergers & AcquisitionsNeurologicalPharmaceuticalRare diseasesShireUSA

Orphan drug approvals rise, but high costs pose challenges for patients

Orphan drug approvals rise, but high costs pose challenges for patients

10-07-2014

Although the pace of approvals for new orphan drugs - medicines that treat relatively rare conditions…

EuropePharmaceuticalPricingRare diseasesRegulationUSA

EU orphan designations for OPKO's clotting Factor VIIa-CTP

EU orphan designations for OPKO's clotting Factor VIIa-CTP

10-07-2014

The European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the…

EuropeFactor VIIa-CTPHematologyOPKO HealthPharmaceuticalRare diseasesRegulation

Novo Nordisk gains FDA backing for new NovoSeven RT indication

Novo Nordisk gains FDA backing for new NovoSeven RT indication

09-07-2014

Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa…

HematologyNovo NordiskNovoSevenNovoSeven RTPharmaceuticalRare diseasesRegulationUSA

New Zealand proposes contestable fund for medicines for rare disorders

New Zealand proposes contestable fund for medicines for rare disorders

09-07-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC will be running a commercial process to fund…

FinancialNew ZealandPharmaceuticalRare diseasesRegulation

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

03-07-2014

US specialty pharma firm Insys Therapeutics yesterday revealed that the US Food and Drug Administration…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

US orphan status for Insys Therapeutics’ cannabidiol for rare form of epilepsy

US orphan status for Insys Therapeutics’ cannabidiol for rare form of epilepsy

25-06-2014

US specialty pharma firm Insys Therapeutics says that the US Food and Drug Administration has granted…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

Another $1 million GSK milestone for Isis Pharma

Another $1 million GSK milestone for Isis Pharma

24-06-2014

USA-based Isis Pharmaceuticals said today that it has earned a $1 million milestone payment from GlaxoSmithKline…

FinancialGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR RxPharmaceuticalRare diseasesResearch

UK’s Summit sets up operations in the USA

UK’s Summit sets up operations in the USA

17-06-2014

UK drug discovery firm Summit, which is focused on therapies for Duchenne muscular dystrophy and Clostridium…

Antibiotics and Infectious diseasesBoardroomManagementPharmaceuticalRare diseasesResearchSummit PharmaceuticalsUSA

US orphan status for EffRx’ EX404 for pediatric polycystic ovary syndrome

US orphan status for EffRx’ EX404 for pediatric polycystic ovary syndrome

11-06-2014

Swiss drug delivery specialist EffRx Pharmaceuticals says the US Food and Drug Administration has granted…

EffRx PharmaceuticalsEX404metforminPharmaceuticalRare diseasesRegulationUSAWomen's Health

EU approval for Janssen's Sylvant to treat patients with MCD

EU approval for Janssen's Sylvant to treat patients with MCD

08-06-2014

The European Commission (EC) has approved the use of Janssen-Cilag International's Sylvant (siltuximab)…

EuropeJanssen-CilagJohnson & JohnsonPharmaceuticalRare diseasesRegulationSylvant

US FDA grants Fast Track designation for GW Pharma’s Epidiolex in Dravet syndrome

US FDA grants Fast Track designation for GW Pharma’s Epidiolex in Dravet syndrome

06-06-2014

The US Food and Drug Administration has granted Fast Track designation to UK-based GW Pharmaceuticals’…

epidiolexGW PharmaceuticalsPharmaceuticalRare diseasesRegulationTreatment of Dravet syndromeUSA

Retrophin acquires US Thiola rights from Mission Pharmacal

Retrophin acquires US Thiola rights from Mission Pharmacal

30-05-2014

US drugmaker Retrophin has entered into a license agreement with Mission Pharmacal, a private company…

LicensingMission PharmacalNephrology and HepatologyPharmaceuticalRare diseasesRetrophinThiolaUSA

Abiogen Pharma out-licenses rights to market Attila in China and nearby territories to Lee’s Pharma

Abiogen Pharma out-licenses rights to market Attila in China and nearby territories to Lee’s Pharma

28-05-2014

Italian drugmaker Abiogen Pharma has signed a license, distribution and supply agreement with Hong Kong-based…

Abiogen PharmaAsia-PacificAttilaChinaLee's PharmaceuticalLicensingPharmaceuticalRare diseases

Santhera muscular dystrophy drug shows success first time in late clinical trial

22-05-2014

For the first time, a drug for Duchenne muscular dystrophy (DMD) – from Swiss drugmaker Santhera Pharmaceuticals…

CatenaPharmaceuticalRare diseasesRaxoneResearchSanthera Pharmaceuticals

Positive Ph III results with Santhera’s Catena/Raxone in Duchenne muscular dystrophy

14-05-2014

Swiss drugmaker Santhera Pharmaceuticals has released positive Phase III, double-blind, placebo-controlled…

CatenaPharmaceuticalRare diseasesRaxoneResearchSanthera Pharmaceuticals

Ipsen takes step forward in the resupply of Increlex for the USA

Ipsen takes step forward in the resupply of Increlex for the USA

13-05-2014

Following previous availability problems, French drugmaker Ipsen said today that a supply of Increlex…

IncrelexIpsenMarkets & MarketingPharmaceuticalProductionRare diseasesUSA

Shire acquires Lumena Pharma, adding to rare disease portfolio

Shire acquires Lumena Pharma, adding to rare disease portfolio

12-05-2014

Ireland-headquartered drugmaker Shire says it will acquire San Diego, USA-based rare disease focussed…

Lumena PharmaceuticalsMergers & AcquisitionsPharmaceuticalRare diseasesShire

Riemser Pharma acquires French drugmaker Keocyt

12-05-2014

German specialty pharmaceutical company Riemser Pharma (formerly Riemser Arzneimittel) said today that…

KeocytMergers & AcquisitionsOncologyPharmaceuticalRare diseasesRiemser Pharma

Common ED drug may help treat effects of muscle disease in boys

08-05-2014

A drug typically prescribed for erectile dysfunction or increased pressure in the arteries may help improve…

PharmaceuticalRare diseasesResearchsildenafilTadalafil

Santhera re-files for EU approval of Raxone in the treatment of LHON

07-05-2014

Swiss drugmaker Santhera Pharmaceuticals has re-filed its Marketing Authorization Application for Raxone…

EuropeOphthalmicsPharmaceuticalRare diseasesRaxoneSanthera Pharmaceuticals

Novartis’ Signifor LAR shows superior efficacy in certain acromegaly patients

Novartis’ Signifor LAR shows superior efficacy in certain acromegaly patients

06-05-2014

Swiss drug major Novartis has presented positive results from a pivotal Phase III trial of investigational…

NovartisPharmaceuticalRare diseasesResearchSignifor

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