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Headlines > February 2017

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Celltrion's MabThera cleared by EC for autoimmune diseases and cancer

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.

Belgian CAR-T biotech enrols first blood cancer patient in new trial

22-Feb-2017 - Celyad SA has enrolled the first multiple myeloma patient in a safety and tolerability trial of its CAR-T therapy.

Opinion

Raging bull' - Vaccines don’t cause autism and saying otherwise costs lives

22-Feb-2017 - Vaccines do not cause autism and people who say otherwise are wrong.

CRB sister Discovery launches second antibody catalogue

21-Feb-2017 - Cambridge Research Biochemicals (CRB) has launched a second catalogue of research antibodies for academia, pharma and outsourcing firms.

Sanofi hires Selexis SA for three cell line development deals

21-Feb-2017 - Sanofi has contracted Swiss biotech Selexis SA to develop cell lines for a three early stage projects.

Abzena to make wet-AMD antibody drug candidate for UCL at US plant

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.

CellGenix GmbH starts work on cell therapy regent facility expansion

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.

Belgian CRO launches EU joint venture with Chromatography Institute

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.

Selecta hires Lonza to make synthetic vector delivered gene therapy

17-Feb-2017 - Selecta Biosciences Inc. has hired Swiss contractor Lonza to make a gene therapy candidate for the metabolic disease, Methylmalonic Acidemia (MMA).

TiGenix hires Lonza to make cell therapy for Crohn's disease complications

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....

News in brief

Charles River Labs up on biologics services

17-Feb-2017 - Charles River Laboratories says it is positioning itself to take advantage of growing demand for biological services.

Strategic CRO takes $100m hit from Pfizer's shelved PCSK9 candidate

17-Feb-2017 - Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.

Biocon's second fill/finish line at Bangalore site to come online later this year

Mylan and Biocon Neulasta biosimilar to go under US FDA scrutiny

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.

Bio-outsourcing share to drop as Big Pharma invests heavily in-house, analyst

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.

Biosimilar group set to lobby new HHS Secretary to reverse reimbursement policy

15-Feb-2017 - Industry group the Biosimilars Forum has welcomed President Trump’s pick of Representative Tom Price as Secretary of Health and Human Services.

Orgenesis granted €12.3m for GMP production ahead of clinical trials

14-Feb-2017 - Orgenesis’ Belgian subsidiary, Orgenesis SPRL, has received €12.3m ($12.8m) to further develop its Type 1 Diabetes program.

Thermo Fisher bags single-use bioreactor tech partner Finesse

14-Feb-2017 - Thermo Fisher Scientific says it is buying Finesse Solutions, its long-term supplier of measurement and control solutions for bioprocessing applications.

Lilly rejects reports US tax plan prompted Ireland investment rethink

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.

Novasep’s €27m viral vector plant to create up to 100 Belgian jobs

14-Feb-2017 - The new viral vector production facility will contain two GMP suites equipped with single-use bioreactors ranging from 200L to 2,000L, says Novasep.

Dutch Biopharma launches Phase III trial of Leukemia donor cell therapy

14-Feb-2017 - Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.

Symbiosis opens US sales office citing demand from resurgent biotechs

13-Feb-2017 - Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.

BriaCell files CMC amendment and preps for breast cancer vaccine trial

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. 

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

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.

GE teams with Austrian research centre to optimise cell line selection

10-Feb-2017 - GE Healthcare has teamed up with the Austrian Centre of Industrial Biotechnology (acib) in an effort to remove trial and error from the cell line optimization process.

Aurobindo building Indian manufacturing plant to support 12 biosimilar pipeline

10-Feb-2017 - Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.

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