22-Feb-2017 - The European Commission has approved Celltrion Healthcare’s rituximab biosimilar – Truxima (CT-P10) – for the same autoimmune disease and cancer indications as the reference product.
21-Feb-2017 - Abzena Plc has been contracted to make an antibody drug candidate for wet age-related macular degeneration by developers at University College London.
21-Feb-2017 - CellGenix GmbH has started expanding its cell and gene therapy reagents facility in Freiburg, Germany citing the progression of customer projects into clinical development and commercial launch.
20-Feb-2017 - The Research Institute for Chromatography (RIC) and Anacura have joined forces to create anaRIC biologics, an R&D and GMP analytical specialist CRO for biologics.
17-Feb-2017 - Selecta Biosciences Inc. has hired Swiss contractor Lonza to make a gene therapy candidate for the metabolic disease, Methylmalonic Acidemia (MMA).
17-Feb-2017 - TiGenix is using Lonza as a US CMO and Takeda as an ex-US commercialization partner to launch and trial its off-the-shelf stem cell therapy for a complication of Crohn’s disease.
17-Feb-2017 - Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
15-Feb-2017 - CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.
14-Feb-2017 - Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.
10-Feb-2017 - BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer.
10-Feb-2017 - Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.
10-Feb-2017 - Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.
09-Feb-2017 - Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
08-Feb-2017 - Catalent is struggling to keep up with demand for its biomanufacturing services, but a third production train will open up more capacity from October.
07-Feb-2017 - Roche says it will continue to expand its biologics manufacturing capacity while reducing its small molecule network.
07-Feb-2017 - Arven will use GE Healthcare’s FlexFactory manufacturing platform to increase capacity at its mammalian-cell based bioproduction facility in Kirklareli, Turkey.
06-Feb-2017 - If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
06-Feb-2017 - CDMO KBI Biopharma, Inc. has acquired the lease and assets of Opexa Therapeutics’ facility in Texas after the firm’s lead MS candidate failed Ph IIb.
03-Feb-2017 - Arven will use GE Healthcare’s FlexFactory manufacturing platform to increase capacity at its mammalian-cell based bioproduction facility in Kirklareli, Turkey.
03-Feb-2017 - The promised jobs were always part of Amgen’s 2017 plans says CEO Robert Bradway, but a reduced US footprint means hiring more biomanufacturing staff is unlikely.
Monitoring spatial product temperature variation is critical to process development and scale-up in the pharma/bio-pharmaceutical indu...
In May 2016, BioPharma-Reporter conducted its inaugural ‘state of the industry’ survey. The key objective of the poll was to gauge vie...