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Astellas US promotes Jeffrey Bloss to SVP of medical affairs for the Americas

Astellas US promotes Jeffrey Bloss to SVP of medical affairs for the Americas

16-04-2014

The US subsidiary of Japanese drug major Astellas Pharma announced that Jeffrey Bloss has been promoted…

Astellas PharmaBoardroomManagementPharmaceuticalUSA

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

AbbVie achieves response rate of 96% in Phase III trials of hepatitis C treatment

AbbVie achieves response rate of 96% in Phase III trials of hepatitis C treatment

14-04-2014

US drugmaker AbbVie has revealed promising new results from its hepatitis C development program at the…

AbbVieAnti-viralsPharmaceuticalResearchUSA

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

Emerging therapies for relapsed/refractory CLL/SLL expected to offer efficacy benefits

Emerging therapies for relapsed/refractory CLL/SLL expected to offer efficacy benefits

11-04-2014

The effect of a therapy on overall survival and progression-free survival are attributes that most influence…

BiotechnologyEuropeGilead SciencesidelalisibImbruvicaJohnson & JohnsonMarkets & MarketingOncologyUSA

Interview: AstraZeneca’s oncology expert Susan Galbraith on the company’s exciting pipeline

Interview: AstraZeneca’s oncology expert Susan Galbraith on the company’s exciting pipeline

11-04-2014

The full year report from Anglo-Swedish drug major AstraZeneca (LSE: AZN) in February was full of optimism.…

AstraZenecaInterviewsIressaOncologyPharmaceuticalUK

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

Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

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