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 ...

On Thursday, the Food and Drug Administration (FDA) publicly called out companies charged with blocking the development of generic drugs. According to generic manufacturers, brand name manufacturers ...

SILVER SPRING, Md., Nov. 21, 2017 /PRNewswire-USNewswire/ -- As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we're focused on taking actions ...

The only way to boost a price by more than 5,000% is to bend the laws of supply and demand in your favor. Turing Pharmaceuticals and its infamous chief executive, Martin Shkreli, presumably knew this ...

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 ...

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 ...

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 ...

Brand-name medications go through extensive clinical trials to show the safety and efficacy of treatment to receive Food and Drug Administration (FDA) approval. Once FDA-approved, the brand ...