The pharmaceutical industry has been revolutionized by the development of biologic medicines.
Biologics (large molecule drugs usually derived from living cells) are transforming the …

The development of an injectable drug-device combination (DDC) product for biologics is
an intricate and evolving process that requires substantial investments of time and money. …

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as
an introduction to the international regulatory arena in which biologicals are developed and …

The pharmaceutical industry lies at the intersection of patent law, antitrust law, federal and
state regulations, and complex markets. For the past several decades, courts and …

The biotechnology segment of the overall biopharma industry has existed for only about 40–45
years, as a driver of new product development. This driving force was initiated with the …

Bringing a new biologic drug to market is a long and expensive process, with research and
development (R&D) cycles that can span up to 15 years and may cost over a billion dollars. …

The global burden of cancer continues to increase as the world’s population grows and
ages. In 2012 there were an estimated 14.1 million new cancer cases and 8.2 million cancer …

With so many biologics in development and no patient-centric way to deliver them, it was
inevitable that innovative delivery solutions would emerge that enable a new pharmaceutical …

• Health care sustainability should be viewed from a holistic perspective recognizing the
long-term societal benefits and cost savings that sustainable competition and access to …

… and Manufacturers of America, a trade association in Washington DC, said that 907 biologics
were in development in the United States alone (Medicines in Development: Biologics …