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Third party ingredient supplier issues delay FDA approval for Pozen NDA

27-04-2014

US drugmaker Pozen says that its drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release…

AspirinCardio-vascularEsomeprazole SodiumNorth AmericaPharmaceuticalPozenRegulationUSA

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

Lilly's Cyramza first FDA-approved drug for advanced gastric cancer after prior chemo

22-04-2014

The US Food and Drug Administration has approved pharma major Eli Lilly’s Cyramza (ramucirumab) as…

CyramzaEli LillyNorth AmericaOncologyPharmaceuticalRegulationUSA

AbbVie files NDA for oral, interferon-free treatment of hepatitis C

22-04-2014

US drugmaker AbbVie has submitted its New Drug Application to the US Food and Drug Administration for…

AbbVieAnti-viralsEnanta PharmaceuticalsFinancialNorth AmericaPharmaceuticalRegulationUSA

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

US Supreme Court denies Teva's request for injunction relating to Mylan’s generic Copaxone

21-04-2014

The US Supreme Court Chief Justice Roberts has denied Israeli generics giant Teva Pharmaceutical Industries’…

CopaxoneGenericsLegalMylan LaboratoriesNeurologicalNorth AmericaPatentsTeva Pharmaceutical IndustriesUSA

FDA approves Merck’s Ragwitek for short ragweed pollen allergies

18-04-2014

The US Food and Drug Administration has approved US pharma giant Merck & Co’s Biological License Application…

ALK AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

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

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

Astellas settles with US DoJ over Mycamine marketing

Astellas settles with US DoJ over Mycamine marketing

17-04-2014

The US subsidiary of Japanese drug major Astellas Pharma will pay $7.3 million to resolve allegations…

Antibiotics and Infectious diseasesAstellas PharmaLegalMarkets & MarketingMycamineNorth AmericaPharmaceuticalUSA

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

16-04-2014

UK pharma giant GlaxoSmithKline yesterday received the much anticipated approval from the US Food and…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationTanzeumUSA

FTC imposes conditions on Akorn’s proposed buy of Hi-Tech Pharmacal

15-04-2014

In order to consummate the proposed $640 million acquisition of Hi-Tech Pharmacal by fellow USA-based…

ActavisAkornGenericsHi-Tech PharmacalMergers & AcquisitionsNorth AmericaUSA

Depomed settlements with two Gralise ANDA filers

15-04-2014

US specialty drugmaker Depomed has entered into settlement agreements with two of the three defendants…

DepomedGenericsGraliseIncepta PharmaceuticalsLegalNeurologicalNorth AmericaPatentsUSAZydus Cadila

Total spending growth returns for US medicines, reports IMS Health

Total spending growth returns for US medicines, reports IMS Health

15-04-2014

Total spending on US medicines increased 1.0% on a real per capita basis in 2013, while the use of health…

FinancialHealthcareMarkets & MarketingNorth AmericaPharmaceuticalUSA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

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

Sylvia Mathews Burwell nominated as next US HHS Secretary as Sebelius quits

Sylvia Mathews Burwell nominated as next US HHS Secretary as Sebelius quits

14-04-2014

On Friday in a Rose Garden ceremony, US President Barack Obama announced that Sylvia Mathews Burwell,…

ManagementNorth AmericaPharmaceuticalPoliticsUSA

Impax Pharma resubmits NDA for Rytary

Impax Pharma resubmits NDA for Rytary

11-04-2014

Impax Laboratories’ branded products division has resubmitted the New Drug Application for Rytary (carbidopa…

Impax LaboratoriesNeurologicalNorth AmericaPharmaceuticalRegulationRytaryUSA

US Judge enforces settlement deal between Mylan and Endo over generic Frova

US Judge enforces settlement deal between Mylan and Endo over generic Frova

11-04-2014

US generic major Mylan today confirmed that a federal district court has granted its request to enforce…

Endo Health SolutionsEndo PharmaceuticalsFrovaGenericsLegalMylan LaboratoriesNeurologicalNorth AmericaPatentsUSA

Potential growth trajectories for the US biopharmaceutical sector

Potential growth trajectories for the US biopharmaceutical sector

11-04-2014

The Pharmaceutical Research and Manufacturers of America (PhRMA) yesterday released a report that outlines…

North AmericaPharmaceuticalPoliticsResearchUSA

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

09-04-2014

US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company…

Halozyme TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationResearchUSA

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

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

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