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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

Basilea appoints David Veitch as chief commercial officer

Basilea appoints David Veitch as chief commercial officer

19-08-2014

Switzerland-based Basilea Pharmaceutica has appointed David Veitch as its chief commercial officer.

Basilea PharmaceuticaBoardroomPharmaceuticalSwitzerland

Ablynx receives $2.8 million grant to investigate nanobodies in eye disease treatment

Ablynx receives $2.8 million grant to investigate nanobodies in eye disease treatment

18-08-2014

Belgian drug developer Ablynx has received a 2.1 million euro ($2.8 million) grant from the Flemish Agency…

AblynxBelgiumOphthalmicsPharmaceuticalResearch

Proposal to expand the quality control of medicines sold in Brazil

Proposal to expand the quality control of medicines sold in Brazil

18-08-2014

Brazilian House Bill 6763/13 introduced by Gorete Pereira (PR-EC) sets the standards to ensure the quality…

BrazilPharmaceuticalProductionRegulation

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

18-08-2014

Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European…

DonepezilEisaiEuropelenvatinibOncologyPharmaceuticalRegulationUSA

Eisai teams up with Zeria on proton pump inhibitor license agreement

Eisai teams up with Zeria on proton pump inhibitor license agreement

18-08-2014

Japanese drug major Eisai has collaborated with fellow Japanese company Zeria Pharmaceutical to conclude…

EisaiGastro-intestinalsJapanLicensingPharmaceuticalProton pump inhibitorsZeria Pharmaceuticals

IQWiG again turns down Eisai’s epilepsy drug Fycompa

IQWiG again turns down Eisai’s epilepsy drug Fycompa

17-08-2014

The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa…

EisaiEpilepsyFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Achillion soars on positive mid-stage hep C drug combo trial

Achillion soars on positive mid-stage hep C drug combo trial

17-08-2014

US drugmaker Achillion saw its share rocket 18.4% to a 52-week high of $9.99 in pre-market trading on…

ACH-3102AchillionAnti-viralsHepatitis C virusPharmaceuticalResearchsofosbuvirSovaldiUSA

Turkish man pleads guilty to importing illegal cancer drugs into USA

Turkish man pleads guilty to importing illegal cancer drugs into USA

17-08-2014

Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges…

AvastinLegalMarkets & MarketingOncologyOzay PharmaceuticalsPharmaceuticalRituxanSabahaddin AkmanTurkeyUSA

In Focus: The role of big data in the drug development process

In Focus: The role of big data in the drug development process

15-08-2014

As big data plays an increasing role in drug development and clinical trials, The Pharma Letter’s Bethany…

Clinical researchInterviewsMedidataPharmaceuticalPharmaceutical sciencesResearchRichard YoungTechnological tools

Brazil plans to update the regulatory framework, expand production of medical products

Brazil plans to update the regulatory framework, expand production of medical products

15-08-2014

The Brazilian Ministry of Health has opened a public consultation to establish the criteria for product…

BrazilFederal governmentPharmaceuticalProductionRegulation

FDA FOCUS: FDA Regulations and Drug Shortages in America

FDA FOCUS: FDA Regulations and Drug Shortages in America

15-08-2014

In the first of a new monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola…

FDAFood and Drug AdministrationPharmaceuticalPharmaceutical sciencesRegulationUSA

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