Breaking News on Biopharmaceutical Development & Manufacturing

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Takeda prepping to take over EU production of stem cell therapy from 2021

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.

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OSE Immunotherapeutics halts recruitment in cancer vaccine trial

OSE Immunotherapeutics SA has halted recruitment in a Phase III trial of its cancer vaccine Tedopi (OSE2101).

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

ImmunoCellular Therapeutics halts brain cancer cell therapy trial due to lack of cash

ImmunoCellular Therapeutics Ltd has halted a Phase III trial of its brain cancer cell therapy ICT-107 due to a lack of funds and is looking for a buyer or partner for the programme.

EMA committee gives Samsung Bioepis nod for Humira biosimilar Imraldi

The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.

Protein A resin maker teams on continuous and column-free chromatography tech

ChromaTan will incorporate Purolite’s Protein A beads into its continuous platform in a move the firms say will up productivity by 15 times over conventional batch chromatography.

Brazilian plant to make Humira biosimilar in 'tobacco-based bioreactors'

A tobacco plant-based platform could make monoclonal antibodies up to 90% cheaper than mammalian systems, says Axis Biotec which is building a pilot plant in Brazil.

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