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17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
17-Jan-2017 - Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.
17-Jan-2017 - The majority of biomanufacturers use single-use systems at least in the development stage says Entegris’ Eric Isberg, but scaling-up will always be a problem.
17-Jan-2017 - Horizon Discovery Group has extended its CRISPR technology license to improve the performance of CHO cell lines for biomanufacturing.
13-Jan-2017 - Sartorius has bolstered its process validation services through the opening of a new validation service laboratory at a site in China.
13-Jan-2017 - Takeda has inked a 5-year deal to finance development of T-cell therapy redirection platform from recently founded biotech, Maverick Therapeutics, with exclusive right to buy.
13-Jan-2017 - Pfizer and industry groups have criticised the US FDA over the randomness of a four-letter suffix demanded in the nonproprietary names of biological products.
12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
11-Jan-2017 - After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.
11-Jan-2017 - The US FDA will decide whether to approve Biocon and Mylan’s version of the Roche breast cancer drug Herceptin by the beginning of September.
11-Jan-2017 - Celltrion deal and multi-million Euro German plant will make it a major second and third wave biosimilars player says Teva.
11-Jan-2017 - Amgen will manufacture, trial and sell cancer immunotherapies developed in collaboration with Immatics Biotechnologies GmbH under an agreement announced this week.
10-Jan-2017 - CSSi LifeSciences and BioMARC have announced a strategic partnership to provide 'fully cohesive product development and support' for vaccine and biologic development.
10-Jan-2017 - Merck has announced plans for process and cell line development centres in the US and China citing biopharmaceutical industry demand for integrated services.
10-Jan-2017 - Sanpower Group says Dendreon's in-house manufacturing set-up will remain in place as it looks to increase US and Asian penetration of the prostate cancer cell therapy.
10-Jan-2017 - Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.
09-Jan-2017 - Orchard Therapeutics has selected Dutch CMO PharmaCell to manufacture products from its gene therapy pipeline.
06-Jan-2017 - PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.
06-Jan-2017 - Trump’s presidency could favour US biosimilars in 2017, but the sector will continue to be hampered by a lack of interchangeability guidance and ongoing litigation, say experts.
06-Jan-2017 - Shire has confirmed it is selling a former Baxalta manufacturing site in Austria once earmarked for a €138m ($145m) expansion and modernisation.
05-Jan-2017 - Cryoport’s network of cold chain logistics will support the delivery of Gradalis Inc’s autologous cell therapy to various cancer trial sites across the US.
05-Jan-2017 - Absorption Systems has announced a technology licensing agreement with Pfizer Inc., in which the pharma company will use the preclinical CRO’s cell lines to test potential drug candidates.
05-Jan-2017 - Bruker has bolstered its molecular biologics and mass spectrometric offering through the acquisition of contract manufacturing organisation (CMO) InVivo Biotech.
04-Jan-2017 - Crown Bioscience will invest $1m into a new subsidiary in Louisiana state to work alongside a new research facility at the New Iberia Research Center (NIRC).
04-Jan-2017 - GE Healthcare hopes to increase the yield of biopharmaceuticals made using its Chinese Hamster Ovary (CHO) expression system through a partnership with synthetic biology firm Synpromics.
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