The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in ...

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 ...

The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device ...

Universities and hospitals are repurposing existing drugs through late-stage trials with funded costs up to 90% lower than ...

Given the high stakes involved, the generic exclusivity period’s effects on competition should be scrutinized.

Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing what he describes as "sham" ...

Generic drug manufacturers are facing increasing pressure from drug distributors, pharmacy benefit managers, and Indian competitors, leading to downward trends in generic drug prices. Which firms are ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

AAM said the law sets up a process under which a drug would have price controls applied before a generic or biosimilar even had the chance to come to market. AAM sends letters to House on HR 987 AAM, ...

Ed Silverman formerly piloted The Wall Street Journal's Pharmalot blog tracking the pharmaceutical industry. His coverage included research and development, marketing, pricing, regulation, deals, ...

Universities and hospitals are repurposing existing drugs through late-stage trials with funded costs up to 90% lower than ...