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Biopharma News

Merck announces FDA filing acceptance of NDA for MK-1293, an investigational follow-on biologic insulin glargine

Merck announces FDA filing acceptance of NDA for MK-1293, an investigational follow-on biologic insulin glargine

8 Aug 2016

Marketing Authorization Application to the EMA currently under review.

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Catalent Biologics and Zumutor collaborate to develop antibodies with enhanced ADCC Activity

Catalent Biologics and Zumutor collaborate to develop antibodies with enhanced ADCC Activity

2 Aug 2016

The partnership created a fucose knockout GPEx cell line expressing high levels of an anti-HER2 antibody.

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Merck to provide Provantage End-to-End development and manufacturing services to Y-mAbs for lead antibody compound

Merck to provide Provantage End-to-End development and manufacturing services to Y-mAbs for lead antibody compound

1 Aug 2016

Includes scale-up and GMP manufacturing of drugs in late-stage development.

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Codexis completes obligations under R&D agreement with leading biopharmaceutical company

Codexis completes obligations under R&D agreement with leading biopharmaceutical company

28 Jul 2016

Enzyme developed with CodeEvolver technology for preclinical therapeutics program exceeds agreement requirements.

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GSK announces significant new investment in UK manufacturing network

GSK announces significant new investment in UK manufacturing network

27 Jul 2016

Investment in advanced manufacturing of new respiratory and biopharmaceuticals portfolio.

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Mylan and Biocon announce regulatory submission for proposed biosimilar Pegfilgrastim accepted for review by EMA

Mylan and Biocon announce regulatory submission for proposed biosimilar Pegfilgrastim accepted for review by EMA

21 Jul 2016

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SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA

SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA

18 Jul 2016

The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe.

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Merck relaunches customer collaboration centers with new concept and M Lab name

Merck relaunches customer collaboration centers with new concept and M Lab name

18 Jul 2016

Enables explorations of new technologies and solutions to address development and manufacturing challenges.

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Cipla to launch South Africa’s first biotech manufacturing facility

Cipla to launch South Africa’s first biotech manufacturing facility

12 Jul 2016

The plant will manufacture biosimilars and construction is scheduled to start in early 2017, with full operations expected to commence in the third quarter of 2018.

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Sartorius Stedim BioOutsource introduces new Released N-Glycan Assay

Sartorius Stedim BioOutsource introduces new Released N-Glycan Assay

7 Jul 2016

In-depth profiling of IgG glycosylation coupled with ADCC assays enables generation of robust biosimilar comparability data.

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Sartorius Stedim Biotech acquires US start-up kSep Systems

Sartorius Stedim Biotech acquires US start-up kSep Systems

6 Jul 2016

Transaction to expand SSB’s bioprocessing product portfolio with innovative single-use centrifuges.

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LEO Pharma enters biologics through strategic partnership with AstraZeneca

LEO Pharma enters biologics through strategic partnership with AstraZeneca

1 Jul 2016

The partnership covers potential new medicines for atopic dermatitis and psoriasis.

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