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EMA update on stolen vials of Herceptin

18-04-2014

The European Medicines Agency has provided an update on the latest information relating to the stolen…

AlimtaEuropeHealthcareHerceptinItalyPharmaceuticalRegulationRemicade

EMA says that vials of falsified Herceptin have been identified

EMA says that vials of falsified Herceptin have been identified

16-04-2014

The European Medicines Agency says it has been informed that vials of Swiss drug major Roche’s blockbuster…

EuropeHealthcareHerceptinOncologyPharmaceuticalRegulationRoche

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

10-02-2014

Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan…

Asia-PacificBioconBiosimilarsCanmabHerceptinHertrazIndiaLegalMylan LaboratoriesOncologyPatentsPharmaceuticalRegulationRoche

Celltrion’s trastuzumab biosimilar, Herzuma, approved in South Korea

16-01-2014

South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar…

Asia-PacificBiosimilarsCellTrionGenericsHerceptinHerzumaOncologyRegulationRoche

Mylan-Biocon Herceptin biosimilar gets first Indian approval

Mylan-Biocon Herceptin biosimilar gets first Indian approval

26-11-2013

US generic major Mylan says that its partner, India-based biotechnology firm Biocon has received approval…

Asia-PacificBioconBiosimilarsGenericsHerceptinHertrazMylan LaboratoriesOncologyRegulationRoche

Roche's new timesaving formulation of Herceptin approved in Europe

02-09-2013

Swiss pharma major Roche (ROG: SIX) revealed this morning (September 2) that a new injectable (subcutaneous)…

BiotechnologyEuropeHerceptinOncologyPharmaceuticalRegulationRoche

HER2-positive breast cancer patients prefer faster subcutaneous administration of Herceptin to IV

15-03-2013

Results from the PrefHer (Patient Preference for Subcutaneous (SC) versus Intravenous (IV) Herceptin)…

EuropeFinancialHealthcareHerceptinOncologyPharmaceuticalRegulationRoche

GlaxoSmithKline pulls sNDA for Tykerb plus Herceptin; Watson/Actavis update

13-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New…

ActavisGenericsGlaxoSmithKlineHerceptinMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRegulationRocheTykerbWatson Pharmaceuticals

Final guidance from UK NICE on Tarceva, Tyverb, Herceptin, Zytiga and Botox

26-06-2012

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today published…

AllerganBotoxEuropeGlaxoSmithKlineHerceptinJanssenJohnson & JohnsonNeurologicalOncologyPharmaceuticalPricingRegulationRocheTarcevaTyverbZytiga

UK NICE gives draft "No" to Benlysta, and negative final guidance for Tyverb and Herceptin

27-04-2012

There was a batch of bad news emanating from the US drugs watchdog the National Institute for Health…

Anti-Arthritics/RheumaticsBenlystaEuropeGlaxoSmithKlineHerceptinOncologyPharmaceuticalPricingRare diseasesRegulationRocheTyverb

NICE views breast cancer drugs from GSK and Roche too expensive

14-02-2012

The UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft…

EuropeGlaxoSmithKlineHerceptinOncologyPharmaceuticalPricingRegulationRocheTyverb

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