All news

To QbD or not to QbD? That is the Question...

To QbD or not to QbD? That is the Question...

By Dan Stanton

Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.

Biopharma Companies Look to New Chromatography Columns

Biopharma Companies Look to New Chromatography Columns

By Zachary Brennan

Biopharma firms, particularly those producing insulin and five of its analogues, have another option in the market of sub-2 micron solid-core chromatography columns with a recent offering from Waters.

Heston was livid

Editor's blog

Lies of The Planet of The Apes?

By Gareth Macdonald

Could a genetically engineered adenovirus really spark a simian revolution and make chimps our masters? BioPharma-Reporter.com looks at the ‘science’ of the 2011 movie “Rise of the Planet of the Apes.” 

EMA Approves First MAb Biosimilars

EMA Approves First MAb Biosimilars

By Dan Stanton

The European Medicine’s Agency (EMA) has approved the first biosimilar monoclonal antibodies and expects to approve increasingly complex biosimilars as the regulatory framework becomes more flexible.

Pfizer Preps for Pipeline with $130m Irish Investment

Correction

Pfizer Preps for Pipeline with $130m Irish Investment

By Dan Stanton

After patent expiration led to facility shuttering and cutbacks, Irish manufacturing will receive a $130m (€100m) boost to prepare for Pfizer’s new pipeline, the company says.

China, Taiwan Begin Shift to Regulatory Convergence

Dispatches from DIA

China, Taiwan Begin Shift to Regulatory Convergence

By Zachary Brennan

In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.

Pharma People: New Board Member at BMS

Pharma People: New Board Member at BMS

By Dan Stanton

BMS have appointed a new director and ex Shire-CEO joins Questcor - yes, you've guessed it, it's in-Pharmatechnologist.com's weekly pharma people round-up.