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September 02, 2015
Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.
August 28, 2015
Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
August 27, 2015
In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.
August 24, 2015
Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.
August 17, 2015
The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.
August 15, 2015
The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.
August 11, 2015
The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.
August 02, 2015
Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
July 30, 2015
The Generic Pharmaceutical Association and the Biosimilars Council wrote an open letter to President Barack Obama protesting the patent protections outlined in the Trans-Pacific Partnership.
July 27, 2015
FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.