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Breaking News on Biopharmaceutical Development & Manufacturing

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WHO further clarifies ‘biological qualifier’ system for naming biological active substances

The fight over how to name biosimilars has taken a turn toward further clarification, with the WHO (World Health Organization) offering another, updated draft of its intended policy on "biological qualifiers" (BQ).

Biogen looks to build $1.1bn manufacturing plant in Switzerland

Biotech company Biogen plans to invest one billion Swiss francs ($1.1bn) in Solothurn, Switzerland to build a new production plant that will create about 400 new jobs beginning in 2019.

Lonza to set up dedicated manufacturing suite for Alexion

Lonza will set up a dedicated manufacturing suite for Alexion, producer of the world’s most expensive drug Soliris.

Transgene to shutter French viral vector plant following Novartis snub

Transgene will close a biomanufacturing facility with the loss of 120 jobs to cut costs after Novartis pulled out of an immunotherapy collaboration last year.

Samsung Bioepis mulls NASDAQ IPO to raise cash for biosimilars

Samsung Bioepis is considering an IPO on the NASDAQ Stock Exchange to raise cash to fund the development of biosimilar products.

US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial

TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.

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