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Breaking News on Biopharmaceutical Development & Manufacturing

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US FDA rejects Amgen bid to force biosims firms to share info before review

Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.

The FDA has rejected Amgen's bid to force biosimilar firms to share pre-review data (Image: Tori Rector)

Biotech fund Flagship Ventures raises $537m for biggest round yet

The venture capital fund that launched Acceleron, Moderna, and Bind Therapeutics has raised $537m (€493m) for another round of funding.

AstraZeneca teams with Harvard to make human beta cells for drug screening

Sourcing human beta cells may soon no longer be a challenge for AstraZeneca diabetes researchers thanks to a new partnership with stem cell scientists at Harvard University.

update

Novasep joins Lonza as Mydicar API producer in deal with Celladon

Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.

AbbVie bucks Puerto Rico departure trend with $30m expansion

AbbVie is investing $30m (€27m) in contract manufacturing facilities in Puerto Rico and plans to create 100 jobs over the next two years.

Spotlight

Judge rejects Amgen’s attempt to block first US biosimilar launch

Judge rejects Amgen’s attempt to block first US biosimilar launch

A district court judge from California has denied an injunction by Amgen meant to stop the launch...

Body clock proteins may be cancer drug targets say researchers

Body clock proteins may be cancer drug targets say researchers

People who work irregular hours get sick more often because proteins that set the human body clock...

Google-backed 23andMe puts gene tech to work in drug discovery

Google-backed 23andMe puts gene tech to work in drug discovery

Google-backed gene testing firm 23andMe is creating a therapeutics group, headed by ex-Genentech veteran Richard Scheller.

DNA ‘Lego’ to accelerate biodrug production say scientists

DNA ‘Lego’ to accelerate biodrug production say scientists

A new technique for creating DNA constructs will accelerate development of bacterial strains for drug production say...

Ebola doctor who received vaccine after needle accident is virus-free

Ebola doctor who received vaccine after needle accident is virus-free

A doctor whose thumb was punctured by a needle while working with Ebola patients in Sierra Leone...

SAFC cell line tech CHOZN by Chinese cancer drug firm BeiGene

SAFC cell line tech CHOZN by Chinese cancer drug firm BeiGene

Chinese cancer drug developer BeiGene will create production cell lines using a platform developed by Sigma Aldrich's...