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Biopharma News

Merck expands end-to-end biodevelopment centers

Merck expands end-to-end biodevelopment centers

10 Jan 2017

Expansionincludes the opening of two new process development centers in the US and China.

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JAMA publishes Mylan and Biocon's proposed biosimilar trastuzumab Phase III data

JAMA publishes Mylan and Biocon's proposed biosimilar trastuzumab Phase III data

27 Dec 2016

Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab.

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FDA extends review of application for Ocrevus

FDA extends review of application for Ocrevus

21 Dec 2016

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

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Planning permission granted for new Shire manufacturing site in Ireland

Planning permission granted for new Shire manufacturing site in Ireland

6 Dec 2016

Site will use the latest bioprocessing techniques and will employ flexible production strategies to enable it to supply both clinical- and commercial-scale products.

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Interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product

Interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product

5 Dec 2016

If approved, the product could provide blood cancer patients with access to potentially life-saving medicine.

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Smaller companies could carve out a sizeable niche in future influenza vaccines space

Smaller companies could carve out a sizeable niche in future influenza vaccines space

30 Nov 2016

New entrants, as well as smaller companies, will expand the use of cell culture-based manufacturing methods to increase their presence.

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Study confirms Sandoz biosimilar etanercept has equivalent efficacy to originator

Study confirms Sandoz biosimilar etanercept has equivalent efficacy to originator

27 Nov 2016

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks.

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Sartorius Stedim Biotech opens new bioanalytical testing laboratory in Boston

Sartorius Stedim Biotech opens new bioanalytical testing laboratory in Boston

10 Nov 2016

New services to enable US biopharmaceutical companies to accelerate development of biosimilars.

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Increased development of highly-targeted biologics set to change composition of asthma therapeutics market

Increased development of highly-targeted biologics set to change composition of asthma therapeutics market

9 Nov 2016

Biologics and monoclonal antibodies to become a bigger presence within the small-molecule-dominated landscape.

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Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab

Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab

8 Nov 2016

Potential to be first submission of a proposed biosimilar trastuzumab in the US.

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EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma

EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma

31 Oct 2016

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

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Boehringer Ingelheim's adalimumab biosimilar candidate shows promise

Boehringer Ingelheim's adalimumab biosimilar candidate shows promise

26 Oct 2016

Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira (adalimumab) in patients with active rheumatoid arthritis.

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