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EMA rejigs biosimilar guidelines to help developers avoid repeating trials

Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.

EMA revises guidelines on biosimilar drug submissions

Ebola update: WHO works with vaccine makers on production bottlenecks

The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.

B-MS extends biologics manufacturing contract with Lonza

Bristol-Myers Squibb (B-MS) and Lonza on Thursday announced a multi-year expansion of their existing biologics manufacturing agreement. 

Amgen chases $3bn biosimilar market with three new programs, biomanufacturing capabilities

Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.

Spotlight

Greenpeace: Industry needs greener disposal for single-use systems

Greenpeace: Industry needs greener disposal methods for single-use systems

Common environmentally practices for single-use systems must be adapted before industry “becomes too set in its ways,”...

Seattle Genetics, Genmab enter ADC collaboration worth up to $211m

Seattle Genetics, Genmab enter ADC collaboration worth up to $211m

Seattle Genetics and Genmab have entered into another antibody-drug conjugate (ADC)partnership under which Genmab will pay $11m...

Purple not the new orange: US FDA biopharmaceuticals list lacks dates

Purple not yet the new orange: US FDA biopharmaceuticals list lacks dates

A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries...

Better together? Biosimilars sector says aye
infographic feature

Better together? biosimilars sector says aye

Partnerships are a mixed bag.For every oppressed group yearning to throw off the yoke of their imperialist...

Shifting pipelines drive AMRI to expand protein expression services

Shifting pipelines drive AMRI to expand protein expression services

AMRI has added protein expression and purification services to its drug discovery services citing the shift in...

Asthma: It’s a mAb, mAb, mAb, mAb world says analyst

Asthma: It’s a mAb, mAb, mAb, mAb world says analyst

Sanofi and Regeneron may overtake Roche and Astrazeneca at the head of the increasingly monoclonal antibody (mAb)...

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