Modern drug development approaches that integrate functional plans with larger business goals are needed for success in early ...

Vivani Medical is developing GLP-1 subdermal implants that aim to provide a consistent therapeutic dose for six months, and ...

Adapting to uncertainty over product review timelines at FDA could complicate M&A for pharma buyers and sellers, especially ...

In the realm of pharmaceutical patent litigation, settlement agreements between branded and generic pharmaceutical companies are frequently used to resolve disputes before, during, and after trials in ...

Social proof—seeing peers safely participate—reduces fear and builds trust in clinical trials. Sharing real stories and ...

On this week's Business of Biotech, Michelle Werner, CEO at Alltrna, talks transfer RNA (tRNA) therapy with host Ben Comer and guest co-host Anna Rose Welch, editorial and community director at ...

In the early 1990s, my grandmother’s health and cognitive abilities started to decline rapidly. She showed clear signs of dementia, which was most likely Alzheimer’s disease but never received a ...

They say the mark of intelligence is making the complex simple. By that standard, navigating early commercialization in the pharmaceutical industry is one of the toughest challenges, especially for ...

Electronic Clinical Outcome Assessments (eCOAs) have advanced considerably, yet persistent myths still prevent clinical teams from leveraging their full value. As regulatory expectations evolve and ...

There are lots of reasons why physicians and patients (and payers) might prefer one drug over another for the treatment of a given disease. Efficacy and safety are paramount, of course, but there are ...

Multiregional clinical trials (MRCTs) have become a cornerstone of global drug development, enabling simultaneous evaluation of therapies while adhering to rigorous standards required for regulatory ...