Latest News in the pharma Industry

Biopharma News

FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer

FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer

5 Feb 2017

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

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Leukocare signs up to become Rentschler's specialized tech partner and formulation developer

Leukocare signs up to become Rentschler's specialized tech partner and formulation developer

2 Feb 2017

Rentschler will become the first and only CDMO to have access to Leukocare's patented SPS formulation technologies.

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Rapid emergence of MENA biologics industry sees first ever Biopharma Conference and new venue at CPhI Istanbul 2017

Rapid emergence of MENA biologics industry sees first ever Biopharma Conference and new venue at CPhI Istanbul 2017

30 Jan 2017

Developments in local manufacturing, regulatory strategies, market entry and harmonisation to be debated by MENA leaders and Government.

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First adalimumab biosimilar candidate recommended for EMA approval

First adalimumab biosimilar candidate recommended for EMA approval

29 Jan 2017

Amgen receives positive CHMP opinion for biosimilar adalimumab.

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Zymeworks opens state-of-the-art lab facility

Zymeworks opens state-of-the-art lab facility

25 Jan 2017

Provides the company with increased control over discovery research, antibody generation, medicinal chemistry and bioconjugation for generating antibody drug conjugates.

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Sartorius Stedim Biotech opens a new validation service laboratory at its Shanghai site

Sartorius Stedim Biotech opens a new validation service laboratory at its Shanghai site

12 Jan 2017

Comprehensive validation services for the Chinese market.

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FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

11 Jan 2017

If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

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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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