MabThera

Showing 15 posts of 26 posts found.

Pfizer scores EU approval for MabThera biosimilar Ruxience

April 6, 2020
Sales and Marketing MabThera, Pfizer, Ruxience, biosimilar

The European Commission has moved to authorise Ruxience, Pfizer’s biosimilar version of MabThera (rituximab).  The decision marks the seventh biosimilar …

Europe’s CHMP recommends Pfizer’s biosimilar of Roche’s MabThera

February 4, 2020
Manufacturing and Production, Sales and Marketing MabThera, Pfizer, Ruxience, biosimilar, pharma

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has revealed that it has awarded a positive opinion for …

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Roche’s Phase 3 Pemphix trial smashes primary endpoint for pemphigus vulgaris

October 14, 2019
Research and Development, Sales and Marketing MabThera, Rituxan, Roche, pharma

Roche has revealed new Phase 3 data demonstrating that its MabThera/Rituxan (rituximab) therapy Pemphix met its primary endpoint in the …

Roche secures US paediatric approval for Rituxan in two rare forms of vasculitis

September 30, 2019
Sales and Marketing MabThera, Rituxan, Roche, pharma, vasculitis

Roche has revealed that Rituxan (rituximab), also known as MabThera, has been awarded US approval from the FDA in combination …

Sandoz biosimilars as safe and efficacious as originators, says early trials data

June 9, 2016
Research and Development Enbrel, MabThera, Novartis, Sandoz, biosimilars, etanercept, rituximab

Sandoz, a division of Novartis, has presented data at the Annual European Congress of Rheumatology (EULAR 2016) demonstrating the safety …

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FDA approves Roche’s Gazyva in follicular lymphoma

February 29, 2016
Research and Development, Sales and Marketing Levact, MabThera

Strong Phase III results have seen the US FDA approve Roche’s Gazyva (obinutuzumab) plus Levact (bendamustine) chemotherapy followed by Gazyva …

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NICE wants more answers from Gilead on Zydelig

June 18, 2015
Sales and Marketing Gilead, MabThera, NICE, Roche, UK, brett wells, zydelig

The National Institute for Health and Care Excellence has not recommended Gilead’s leukaemia drug Zydelig in draft guidance.  But the …

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Roche buoyed by cancer drug sales

April 22, 2015
Sales and Marketing Actemra, Cancer, Esbriet, Esbriet., MabThera, Q1, Rituxan, RoActemra, Roche, Xolair, avastin, oncology

Pharma’s biggest cancer drugs maker Roche has reported strong sales growth on the back of its oncology portfolio for its …

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NICE U-turn on Roche leukaemia drug

December 2, 2014
Sales and Marketing Gazyvaro, MabThera, NHS, NICE, Roche, leukaemia, obinutuzumab

NICE has reversed its decision on Roche’s chronic lymphocytic leukaemia (CLL) drug Gazyvaro only two months after rejecting the drug. …

MabThera Roche

Blood cancer injection given green light

August 5, 2014
Research and Development, Sales and Marketing MabThera, Roche, follicular lymphoma and small lymphocytic lymphoma

Roche has launched a new injection formulation of its blood cancer drug MabThera (rituximab) to treat patients with follicular lymphoma, …

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NICE U-turn on MabThera

October 3, 2013
Sales and Marketing MabThera, NHS, NICE, Roche

NICE is thinking about recommending Roche’s MabThera for a rare autoimmune condition – a move which represents a partial victory …

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NICE ‘no’ for MabThera

July 23, 2013
Sales and Marketing MabThera, NHS, NICE, Roche

Roche has been dealt a blow by NICE, with the health watchdog deciding that MabThera should not be used on …

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EMA backs MabThera despite contamination issue

May 29, 2012
Manufacturing and Production EMA, MabThera, Phil Taylor, Roche, manufacturing

The European Medicines Agency has completed a safety review of Roche’s MabThera convened after bacterial contamination was discovered in bioreactors …

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Indian CMO will make Roche blockbusters

March 6, 2012
Manufacturing and Production Emcure, Herceptin, India, MabThera, Pegasys, Roche

Roche has reportedly signed an agreement with Emcure Pharmaceuticals of India that will see the latter manufacturing its blockbuster drugs …

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