All news articles for August 2014

Ebola false alarm in France

Ebola false alarm in France

By Gareth Macdonald

Concerns passengers on a flight from Paris to Montpellier had the Ebola virus have proved to be false according to reports in the French media.

Japanese biotech adopts MES at recombinant flu vaccine plant

Japanese biotech adopts MES at recombinant flu vaccine plant

By Zachary Brennan

Japanese biotech company Unigen has implemented in only four months Werum's PAS-X Manufacturing Execution System (MES), which can help optimize production output at the world’s largest plant for the contract manufacturing of recombinant flu vaccines.

Industry slams FDA draft guidance on biosimilarity

Industry slams FDA draft guidance on biosimilarity

By Zachary Brennan

Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its...

Biopharma companies race to develop Ebola vaccine

Biopharma companies race to develop Ebola vaccine

By Zachary Brennan

As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.

Institutional investors decry US battle over biosimilars

Institutional investors decry US battle over biosimilars

By Zachary Brennan

As Celltrion announced Monday that it filed the first monoclonal antibody for approval with the US FDA, investor groups are crying foul over some of the tactics used by others in industry to discourage the uptake of biosimilars in the US.

NIST project works to standardize ID of CHO, rat cell lines

NIST project works to standardize identification of CHO, rat cell lines

By Zachary Brennan

Though mostly known for its work in measurements, the National Institute of Standards and Technology’s work is expanding in biomanufacturing and specifically looking to standardize the identification of CHO (Chinese hamster ovary) and rat cell lines as...

The new modular guideline is intended to update in a consolidated document the existing guidance

EMA revises guidance on developing flu vaccines

By Zachary Brennan

The European Medicines Agency (EMA) has released a second module of a new guideline on influenza vaccines for a six-month public consultation, which covers the non-clinical and clinical requirements for the development of new flu vaccines. 

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