The Competitive Generic Therapy designation looks to encourage the development of alternatives for drugs with inadequate generic competition. The Food and Drug Administration on Wednesday approved a ...

Think generics is limited to ANDAs and patent challenges? Think again. Marketing and R&D must work together on creating the value proposition of the product, just like in brand pharma, writes Kathy ...

Millions of Americans report that they are unable to fill their prescriptions or are not taking their medications as prescribed because they cannot afford them, generating bipartisan interest in ...

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...

Photo courtesy of starline on Freepik. Opinions expressed by Digital Journal contributors are their own. Santosh Kesarpu has established expertise in complex generic formulation, applying rigorous ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...