MabThera
Pfizer scores EU approval for MabThera biosimilar Ruxience
April 6, 2020Sales 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, 2020Manufacturing 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 …
Roche’s Phase 3 Pemphix trial smashes primary endpoint for pemphigus vulgaris
October 14, 2019Research 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, 2019Sales 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, 2016Research 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 …
FDA approves Roche’s Gazyva in follicular lymphoma
February 29, 2016Research 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 …
NICE wants more answers from Gilead on Zydelig
June 18, 2015Sales 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The National Institute for Health and Care Excellence has not recommended Gilead’s leukaemia drug Zydelig in draft guidance.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 …
NICE U-turn on Roche leukaemia drug
December 2, 2014Sales 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. …
Blood cancer injection given green light
August 5, 2014Research 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, …
NICE U-turn on MabThera
October 3, 2013Sales 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 …
NICE ‘no’ for MabThera
July 23, 2013Sales 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 …
EMA backs MabThera despite contamination issue
May 29, 2012Manufacturing 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 …
Indian CMO will make Roche blockbusters
March 6, 2012Manufacturing 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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