Analytical (technologies & services)

Majority of EU member states say ‘no’ to INNs for biosimilars

Majority of EU member states say ‘no’ to INNs for biosimilars

By Zachary Brennan

Most EU member states “strongly supported” the idea that biosimilars should be closely aligned with their reference products, according to a summary of the European Commission’s pharmaceutical committee meeting released Monday.

EBE says EC must do more on biodrug assessments

EBE says EC must do more on biodrug assessments

A biomanufacturing industry group has rejected the European Commission’s view that current regulations are flexible enough to apply to biopharmaceuticals and says more need to be done.

ADCs a big opportunity for Big Pharma say experts

Big Pharma business opportunities driving ADC boom say experts

By Gareth Macdonald

Big Pharma interest in antibody drug conjugates (ADC) hit another high this week with Roche  ,Novartis and AstraZeneca each announcing investments that boost their ability to develop and manufacture these small-molecule monoclonal antibody (mAb) drug...

Agilent splits up to create two separate businesses

Agilent splits up to create two separate businesses

Agilent Technologies has officially separated its biopharma service offerings from its electric measurement group to create two separate companies, the life science portion of which is expected to bring in about $3.9B in FY2013.

New Melanoma Vaccine Tech Enters Ph I Trial

Harvard’s New Melanoma Vaccine Tech Enters Ph I Trial

By Zachary Brennan

A newly developed implantable melanoma vaccine is now in Phase I clinical trials thanks to the efforts of a cross-disciplinary team of engineers, scientists and clinicians from Harvard University and the Dana-Farber Cancer Institute.

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.

Thermo Fisher Acquires Life Tech for $13.6B

Update

Thermo Fisher Acquires Life Tech for $13.6B

By Zachary Brennan

Thermo Fisher Scientific has agreed to purchase genetic testing equipment maker Life Technologies for $13.6B in one of the biggest acquisitions of the year.