Drug Development

Articles

The agency releases guidance on controlled correspondences related to generic-drug development.

FDA Releases Guidance on Generic-Drug Development

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

There is growing interest in the development of liquid formulations in prefilled syringes and autoinjectors, which offer convenience and ease of administration in a home setting.

Trends in Biologics Drug Delivery

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

Cobra Biologics Announces Scale-Up Collaboration

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

FDA Promotes Its Scientific Mission

The company will showcase its range of drug packaging and delivery systems as well as launch a new ready-to-use validated packaging component.

West Pharma to Showcase Prefilled Components and Self-Injection Devices at CPhI/Innopack 2015

West Pharmaceutical Services and HealthPrize Technologies are collaborating on self-reporting and bar coding capabilities for injectable drug-delivery systems.

Injectable Systems with Adherence Tracking Capabilities

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

EMD Millipore Provides Risk-Assessment Information for Raw Materials

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.

Nexvet Secures Biomanufacturing Facility for Veterinary Biologics

Manufacturers challenge details in new policies designed to promote access to important therapies.

FDA Faces Controversy Over Quality Metrics and Biosimilars

Lannett Company agreed to purchase Kremers Urban Pharmaceuticals, the US specialty generic-pharmaceuticals subsidiary of global biopharmaceuticals company UCB S.A., for $1.23 billion.

Formulation and Drug Delivery