Drug Development

Virginia Acha, DPhil, is director of regulatory policy, Europe, Middle East and Africa, at Amgen.

Articles

To realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.

Emerging Opportunities with Biosimilars

Stephen Tindal is director, Formulation and Site R&D Lead at Catalent Pharma Solutions.

Stephen Tindal from Catalent Pharma Solutions speaks with Pharmaceutical Technology Europe about advances in softgel technologies.

Opportunities with Softgels

Kaspar van den Dries, PhD, is senior director formulation sciences, solid dosage forms and softgels at Patheon.

Softgels are now being recognised as one of the preferred dosage forms for the treatment of pain, eye conditions, cough and cold, as well as allergy.

Past, Present and Future of Softgel Technologies

Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.

Contractors Invest in Capacity and Capabilities

Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.

Technologies Key for Biologics to Meet Expectations

Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.

Pfizer to Acquire Vaccines from Baxter

Redbiotec and GE Healthcare Life Sciences develop a novel manufacturing process for virus-like particles.

Redbiotec Collaborates with GE Healthcare Life Sciences on Vaccine Development and Manufacturing

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate

Study provides first substantive reference data on key quality attributes of empty capsules

Study Shows Capsugel's Capsules as Suitable Excipients in QbD-based Product Development and Manufacturing

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

Formulation and Drug Delivery