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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

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

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

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

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

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

US CMS ensures higher value and quality for Medicare health and drug plans

08-04-2014

The US Centers for Medicare & Medicaid Services (CMS) issued the 2015 rate announcement and final call…

FinancialHealthcareNorth AmericaPharmaceuticalUSA

Sunovion’s once-daily epilepsy drug Aptiom debuts in USA

08-04-2014

USA-based Sunovion Pharmaceuticals, a subsidiary of Japanese drug major Dainippon Sumitomo, has launched…

AptiomDainippon Sumitomo PharmaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalSunovionUSA

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee on Monday voted unanimously…

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

Lilly's Alimta patent upheld through 2022

Lilly's Alimta patent upheld through 2022

01-04-2014

US pharma major Eli Lilly says that the US District Court for the Southern District of Indiana has ruled…

AlimtaEli LillyLegalNorth AmericaOncologyPatentsPharmaceuticalTeva Pharmaceutical IndustriesUSA

US Supreme Court agrees to hear Teva’s Copaxone patent appeal

US Supreme Court agrees to hear Teva’s Copaxone patent appeal

01-04-2014

Israel’s Teva Pharmaceutical Industries, the world largest generic drugmaker, says that the US Supreme…

CopaxoneLegalNeurologicalNorth AmericaPatentsPharmaceuticalTeva Pharmaceutical IndustriesUSA

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