Day: July 14, 2022

For patients with untreatable serious or life-threatening diseases, the benefit of compassionate use or expanded access programs is indisputable. However, companies providing drugs to patients under these programs can also use these as opportunities to generate valuable real-world data in support of their regulatory applications. A report by Novartis’ compassionate use program recommends three steps … Read more

FDA approved drugs that have none or few generic versions are designated as Competitive Generics with special incentives to developers under a law passed in 2017 aimed to avoid monopolies that lead to price gouging. Manufacturers based in India dominate the development of competitive generis with almost 55% of all such generics developed by Indian … Read more