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US Office of Generic Drugs reorganization

US Office of Generic Drugs reorganization

29-12-2013

The US Food and Drug Administration’s Center for Drug Evaluation and Research has approved plans to…

GenericsNorth AmericaRegulationUSA

Hepalink to acquire USA’s Scientific Protein Laboratories

27-12-2013

China’s Shenzhen Hepalink Pharmaceutical has entered into a stock purchase agreement to acquire USA-based…

GenericsheparinMergers & AcquisitionsScientific Protein LaboratoriesShenzhen Hepalink Pharmaceutical

ANI Pharma buys 31 generic drugs from Teva

ANI Pharma buys 31 generic drugs from Teva

27-12-2013

Emerging US generic drugmaker ANI Pharmaceuticals says that it has acquired 31 previously marketed generic…

ANI PharmaceuticalsGenericsMergers & AcquisitionsTeva Pharmaceutical Industries

European Commission backs wider use of Merck’s Erbitux

European Commission backs wider use of Merck’s Erbitux

24-12-2013

Merck Serono, the biopharmaceutical division of Germany’s Merck KGaA, has gained European Commission…

ErbituxEuropeMerck KGaAMerck SeronoOncologyPharmaceuticalRegulation

Sandoz to commercialize Taiwan Liposome’s antifungal

Sandoz to commercialize Taiwan Liposome’s antifungal

19-12-2013

Taipei-based biopharmaceutical company Taiwan Liposome Company has entered into a collaboration agreement…

Amphotericin BAntibiotics and Infectious diseasesAsia-PacificGenericsLicensingNovartisSandozTaiwan Liposome

Rapid uptake of rheumatoid arthritis biosimilars expected in Brazil and Mexico

19-12-2013

Biosimilars will be quickly acquired and used in public health institutions in the treatment of patients…

Anti-Arthritics/RheumaticsBiosimilarsBrazilGenericsMarkets & MarketingRegulationSouth America

Joint generic drug inspections initiative announced by FDA and EMA

Joint generic drug inspections initiative announced by FDA and EMA

19-12-2013

In a joint statement, the US Food and Drug Administration and the European Medicines Agency revealed…

EuropeGenericsNorth AmericaProductionRegulation

Brazil’s ANVISA and ProGenericos sign cooperation agreement

Brazil’s ANVISA and ProGenericos sign cooperation agreement

18-12-2013

Brazil's National Health Surveillance Agency, ANVISA has signed a memorandum of technical and operational…

BiosimilarsBrazilGenericsRegulationResearchSouth America

Lack of familiarity with biosimilars among South Korean oncologists

Lack of familiarity with biosimilars among South Korean oncologists

16-12-2013

South Korean oncologists are significantly less familiar with biosimilars than oncologists surveyed in…

Asia-PacificBiosimilarsChinaGenericsOncology

FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

12-12-2013

Following a public comment period, the US Federal Trade Commission has approved a final order settling…

ActavisGenericsMergers & AcquisitionsNorth AmericaRegulationReproductiveWarner Chilcott

Zydus Cadila settles Asacol patent litigation in USA

11-12-2013

Zydus Cadila, one of India’s largest privately-held pharmaceuticals companies, and affiliate Zydus…

ActavisAsacol HDGastro-intestinalsGenericsNorth AmericaPatentsWarner ChilcottZydus Cadila

Australian government urged to hold the line on IP protection

Australian government urged to hold the line on IP protection

11-12-2013

The Generic Medicines Industry of Australia (GMiA) is renewing its call on the Australian government…

Asia-PacificAustraliaGenericsPatents

Teva vice chairman Moshe Many to leave post for 'personal reasons'

Teva vice chairman Moshe Many to leave post for 'personal reasons'

11-12-2013

Israel’s Teva Pharmaceutical Industries announced yesterday that the vice chairman of its board of…

BoardroomGenericsManagementTeva Pharmaceutical Industries

Russian government to change mechanism for setting prices for essential drugs

Russian government to change mechanism for setting prices for essential drugs

10-12-2013

The Russian government is considering changing the mechanism of setting prices for essential drugs in…

Eastern EuropeGenericsPharmaceuticalPricingRussia

Actavis sells 51% stake in Russian subsidiary

Actavis sells 51% stake in Russian subsidiary

10-12-2013

Leading global generics drugmaker Actavis says that it sold its 51% stake in the Russian drug company…

ActavisEastern EuropeFarmekoGenericsMergers & AcquisitionsRussiaZio-Zdorovye

Low level of “potentially problematic” patent settlements in EU pharma sector

Low level of “potentially problematic” patent settlements in EU pharma sector

09-12-2013

The European Commission's report on patent settlement agreements, also referred to as “pay-for-delay”…

EuropeFinancialGenericsPatentsPharmaceutical

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