Formulation and Drug Delivery

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

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

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

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.

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

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.

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

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

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).

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

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

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

Vetter’s Vetter-Ject closure system for prefilled syringes has an integrated needle hub and shield and is designed for sensitive compounds, such as biologics.

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

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.

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.