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Headlines > January 2017

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Biosimilar interchangeability

FDA calls for switching studies in draft interchangeability guidelines

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developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.

GEA and Siemens team on continuous processing tech

17-Jan-2017 - Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.

Exclusive interview

Single-use bioreactors: 2,000L a ceiling, says new BPSA board member

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.

Horizon to use CRISPR tech to enhance CHO cell lines for biomanufacturing

17-Jan-2017 - Horizon Discovery Group has extended its CRISPR technology license to improve the performance of CHO cell lines for biomanufacturing.

News in brief

Sartorius opens Shanghai validation testing lab

13-Jan-2017 - Sartorius has bolstered its process validation services through the opening of a new validation service laboratory at a site in China.

Takeda in $125M deal for startup’s ‘unique’ Immuno-oncology platform

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.

US FDA sticks with four-letter random suffix for biosimilar names

‘Meaningless suffixes’ slammed by industry in FDA naming guidance

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.


Trump vows to bring drug production back to US

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. 

AGC boasts 44,000L of biomanufacturing capacity on back of recent M&A

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.

US Herceptin biosimilar one step closer as FDA accepts Mylan BLA

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.

Teva aiming to be major second and third wave biosimilars company

Teva: ‘Celltrion deal will double biosimilar sales to $600m’

11-Jan-2017 - Celltrion deal and multi-million Euro German plant will make it a major second and third wave biosimilars player says Teva.

Amgen teams with Immatics on cancer immunotherapies

11-Jan-2017 - Amgen will manufacture, trial and sell cancer immunotherapies developed in collaboration with Immatics Biotechnologies GmbH under an agreement announced this week.

Strategic partnership forms single-source solution for biopharma

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. 

German Merck to build biodevelopment centres in US and China

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.

Valeant selling Provenge maker Dendreon to Chinese conglomerate for $820m

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.

Kite inks Chinese JV and Japanese partnership for lead T Cell candidate

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.

Orchard picks PharmaCell to make its autologous cell therapies

09-Jan-2017 - Orchard Therapeutics has selected Dutch CMO PharmaCell to manufacture products from its gene therapy pipeline.


Cell-in-a-Box: PharmaCyte seeks FDA advice for inoperable cancer trial

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.

US biosimilars will continue to blossom under Trump, say experts

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.

Shire selling Baxalta site in Austria once earmarked to make hemophilia drug

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.


Cryoport to deliver Gradalis autologus immuno-oncology therapies across US

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.

Pfizer licenses cell lines from preclinical CRO, Absorption Systems

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.

Bruker buys mAb and immunoassay supplier InVivo

05-Jan-2017 - Bruker has bolstered its molecular biologics and mass spectrometric offering through the acquisition of contract manufacturing organisation (CMO) InVivo Biotech.

CrownBio expands into Louisiana primate research center with $1m facility

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).

Synpromics to develop synthetic promotors for GE’s CHO platform

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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