Drug Development

Articles

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Experts from Dow Pharma & Food Solutions discuss the versatility of solid dispersions in solubility enhancement and the importance of pairing the active pharmaceutical ingredient to the optimal polymer.

A Case for Solid Dispersions

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

Cell Culture, Single Use, and the Evolving Biopharmaceutical Landscape

Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions shares insights on trends shaping the evolving solid dosage manufacturing landscape, including advances in excipients and the impact on formulation development and manufacturing processes.

Key Considerations in Excipients Selection for Solid Dosage Forms

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

AbbVie Amends its Citizen Petition to FDA

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.

Excipient Selection for Protein Stabilization

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

Hermes Pharma Expands Formulation Services to US Market

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

CMC Biologics to Manufacture mAbs for the Treatment of Malaria

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

Formulation and Drug Delivery