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Rapid expansion forecast for global Cushing’s syndrome drug market

Rapid expansion forecast for global Cushing’s syndrome drug market

29-01-2015

The global Cushing’s syndrome (CS) treatment market will expand rapidly in value from around $179 million…

CortendoEuropeHRA PharmaKetoconazoleMarkets & MarketingMetabolicsNormoCortNovartisPharmaceuticalRare diseasesSigniforUSA

FDA approves Teva’s Granix and Galderma’s Soolantra

FDA approves Teva’s Granix and Galderma’s Soolantra

24-12-2014

The Food and Drug Administration has approved Israeli generics giant Teva Pharmaceutical Industries’…

DermatologicalsGaldermaGranixIvermectinPharmaceuticalRare diseasesRegulationSoolantraTeva Pharmaceutcal IndustriesUSA

Novartis gains US FDA approval of Signifor for acromegaly

Novartis gains US FDA approval of Signifor for acromegaly

16-12-2014

The US Food and Drug Administration has approved Swiss pharma giant Novartis’ Signifor (pasireotide)…

NovartisPharmaceuticalRare diseasesRegulationSigniforUSA

OPKO Health leaps on potential $570 million deal with Pfizer

OPKO Health leaps on potential $570 million deal with Pfizer

15-12-2014

US drugmaker OPKO Health saw its shares leap 13.8% in pre-market trading, when it revealed a licensing…

LicensingOPKO HealthPfizerPharmaceuticalRare diseasesUSA

Takeda receives Breakthrough designation for ixazomib

Takeda receives Breakthrough designation for ixazomib

05-12-2014

Japanese drug major Takeda Pharmaceutical’s has been granted Breakthrough Therapy designation from…

ixazomibPharmaceuticalRare diseasesRegulationTakeda PharmaUSA

Alizé Pharma acquires exclusive worldwide rights for new peptide to tackle bone diseases

03-12-2014

Alizé Pharma, a group of privately-held biopharmaceutical companies specialized in the development of…

Alize PharmaLicensingPharmaceuticalRare diseasesUSA

OPEN Act introduced in USA to repurpose drugs for rare diseases

OPEN Act introduced in USA to repurpose drugs for rare diseases

26-11-2014

Last week, US Representatives Gus Bilirakis (Republican, Florida) and G K Butterfield (Democrat, North…

PharmaceuticalPoliticsRare diseasesRegulationUSA

Sarepta will rebound strongly from eteplirsen US delay, says analyst

06-11-2014

US rare and infectious disease specialist Sarepta Therapeutics remains a strong contender in the Duchenne…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationSarepta TherapeuticsUSA

US FDA reveals discussions with Sarepta over eteplirsen

US FDA reveals discussions with Sarepta over eteplirsen

31-10-2014

In what is viewed as an unusual step, the US Food and Drug Administration made a website posting of its…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationResearchSarepta TherapeuticsUSA

FDA approves Baxter’s new treatment for rare form of hemophilia

FDA approves Baxter’s new treatment for rare form of hemophilia

25-10-2014

The US Food and Drug Administration on Friday approved Obizur (antihemophilic Factor [recombinant), porcine…

Baxter InternationalHematologyObizurPharmaceuticalRare diseasesUSA

EMA urging firms with Ebola candidates to seek orphan status

21-10-2014

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola…

Anti-viralsEuropePharmaceuticalRare diseasesRegulationResearchUSA

BTG settles CroFab patent litigation with Bioclon and RDT

10-10-2014

UK specialist health care company BTG says it has settled its US patent infringement complaint against…

BTGCrofabInstituto BioclonLegalPatentsPharmaceuticalRare Disease TherapeuticsRare diseasesUSA

FDA grants to stimulate drug and device development for rare diseases

FDA grants to stimulate drug and device development for rare diseases

01-10-2014

The US Food and Drug Administration yesterday announced it has awarded 15 grants totaling more than $19…

FinancialPharmaceuticalRare diseasesResearchUSA

Depomed wins in law suit seeking FDA orphan drug exclusivity for Gralise

Depomed wins in law suit seeking FDA orphan drug exclusivity for Gralise

07-09-2014

US specialty drugmaker Depomed says that Judge Kentaji Brown Jackson of the federal district court for…

DepomedGraliseLegalNeurologicalPharmaceuticalRare diseasesUSA

FDA approves Elelyso for pediatric use in Gaucher disease

FDA approves Elelyso for pediatric use in Gaucher disease

29-08-2014

The US Food and Drug Administration has approved US pharma giant Pfizer’s Elelyso (taliglucerase alfa)…

ElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationUSA

FDA backs added indication for GSK’s Promacta

FDA backs added indication for GSK’s Promacta

27-08-2014

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug…

GlaxoSmithKlineHematologyLigand PharmaceuticalsPharmaceuticalPromactaRare diseasesRegulationRevoladeUSA

Prosensa and CureDuchenne expand DMD collaboration with $7 million funding boost

Prosensa and CureDuchenne expand DMD collaboration with $7 million funding boost

12-08-2014

Dutch biotech company Prosensa will receive a 5 million euros ($7 million) funding boost from US non-profit…

Duchenne Muscular DystrophyFinancialNetherlandsPharmaceuticalProsensaRare diseasesResearchUSA

US and European orphan status for AbbVie’s glioblastoma candidate

US and European orphan status for AbbVie’s glioblastoma candidate

04-08-2014

Both the European Medicines Agency and the US Food and Drug Administration have granted orphan drug designation…

AbbVieABT-414Brain tumorEuropeGlioblastoma multiformeMarkets & MarketingOncologyPharmaceuticalRare diseasesRegulationUS Food and Drug AdministrationUSA

Shire finally accepts AbbVie’s takeover offer

Shire finally accepts AbbVie’s takeover offer

18-07-2014

After a protracted and at times hostile courtship, Ireland-headquartered drugmaker Shire has finally…

AbbVieHumiraMergers & AcquisitionsNeurologicalPharmaceuticalRare diseasesShireUSA

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

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

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

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