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Public Citizen expert slams aspects of FDA draft drug labeling guidance

21-08-2014

The US Food and Drug Administration recently issued draft guidance that would let the pharmaceutical…

PharmaceuticalRegulationUSA

US federal court issues restraining order against FDA's approval for generics of Hospira's Precedex

US federal court issues restraining order against FDA's approval for generics of Hospira's Precedex

21-08-2014

A judge in US federal court has issued a temporary restraining order following the US Food & Drug Administration’s…

Food and Drug AdministrationHospiraMylanNeurologicalPharmaceuticalPrecedexUSA

Cynthia Schwalm appointed as president and chief executive of Ipsen North America

Cynthia Schwalm appointed as president and chief executive of Ipsen North America

21-08-2014

French drugmaker Ipsen has appointed Cynthia Schwalm as president and chief executive of its North American…

BoardroomIpsenNorth AmericaPharmaceutical

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

21-08-2014

UK pharma giant GlaxoSmithKline revealed late yesterday that the US Food and Drug Administration has…

Arnuity ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUSA

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

20-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products,…

Federal Joint CommitteeGermanyJakaviMyelofibrosisNovartisOncologyPharmaceuticalPricingRare diseasesRegulation

Mood lifts for Medtech in first half of 2014, while Pharma sector faces new struggles

Mood lifts for Medtech in first half of 2014, while Pharma sector faces new struggles

20-08-2014

An M&A frenzy that accounted for nearly $90 billion of equity set the pace for the first half of 2014…

FinancialGlobalJonathan GardnerMergers & AcquisitionsPharmaceutical

Russia’s Peptogen launches production of innovative CV drugs

Russia’s Peptogen launches production of innovative CV drugs

20-08-2014

Sergei Sobyanin, Mayor of Moscow, has officially launched a new Russian plant for the production of innovative…

Cardio-vascularHeart attacksMoscowPeptogenPharmaceuticalProductionRussiaSergey SobyaninStrogino

Clinigen adds to oncology portfolio with AstraZeneca’s Ethyol

Clinigen adds to oncology portfolio with AstraZeneca’s Ethyol

20-08-2014

UK-based Clinigen Group has acquired the global rights to the oncology support therapy Ethyol (amifostine)…

ClinigenClinigen GroupEthyolLicensingOncologyPharmaceuticalTreatment for head and neck cancerUK

Depomed prevails in Gralise ANDA litigation with Actavis

Depomed prevails in Gralise ANDA litigation with Actavis

20-08-2014

US drug maker Depomed saw its shares climb more than 12% to $14.76 on Tuesday, on the news that the firm…

ActavisDepomedGraliseLegalNeurologicalPatentsPharmaceuticalUSA

Novartis to start production of Tasigna in Russia

Novartis to start production of Tasigna in Russia

19-08-2014

Russia’s largest drugmaker Pharmstandard has signed an agreement with Swiss pharma major Novartis on…

CancerCytokinesHealth Medical PharmaIgor KrylovMajorNovartisOncologyPharmaceuticalPharmstandardProductionRussiaTasigna

EXPERT VIEW: Pfizer and AstraZeneca, a marriage not to be – yet?

EXPERT VIEW: Pfizer and AstraZeneca, a marriage not to be – yet?

19-08-2014

Mergers and acquisitions may excite the markets and shareholders on both sides but their record of success…

GlobalInterviewsMergers & AcquisitionsPharmaceutical

Pfizer files palbociclib NDA with FDA for breast cancer

Pfizer files palbociclib NDA with FDA for breast cancer

19-08-2014

US pharma giant Pfizer says it has completed the submission of a New Drug Application to the US Food…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

Provectus opens negotiations on licensing PV-10 in China

Provectus opens negotiations on licensing PV-10 in China

19-08-2014

US developmental stage company Provectus Biopharmaceuticals has entered into a memorandum of understanding…

Breast cancerChinaLicensingMemorandum of understandingOncologyPharmaceuticalProvectus BiopharmaceuticalsPV-10Sinopharm

US DoJ closes investigation into AstraZeneca’s PLATO trial for Brilinta

US DoJ closes investigation into AstraZeneca’s PLATO trial for Brilinta

19-08-2014

Anglo-Swedish drug major AstraZeneca has received confirmation from the US Department of Justice that…

AstraZenecaBrilintaBrilintaCardio-vascularLegalPharmaceuticalUKUSA

Allergan names Jim Hindman chief financial officer

Allergan names Jim Hindman chief financial officer

19-08-2014

Allergy specialist Allergan has appointed Jim Hindman as chief financial officer, effective immediately,…

AllerganBoardroomBusiness FinanceBusiness FinanceChief financial officerJim HindmanPharmaceuticalUSA

Indian Health Ministry seeking compulsory license for B-MS’ Sprycel

Indian Health Ministry seeking compulsory license for B-MS’ Sprycel

19-08-2014

Anti-leukemia drug dasatinib, made by US pharma major Bristol-Myers Squibb and sold in India under the…

Bristol-Myers SquibbDasatinibIndiaOncologyPatentsPharmaceuticalSprycel

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