On the 19th of January, 2017, the US Food and Drug Administration (FDA) officially launched its Oncology Center of Excellence (OCE) as part of the former Vice President’s Cancer Moonshot Initiative. This exciting new development [...]
Historically, pharmaceutical companies have focused their efforts on developing so-called ‘blockbuster' drugs, i.e. those drugs that treat common conditions, with large patient populations, and that are expected to generate revenues greater than $1 billion per [...]
Expanded Access Programs (EAPs), also known as Managed Access Programs, help sick patients gain access to drugs that are not available through traditional access routes. These can be drugs that are still in development, in [...]
On Tuesday, the US Food and Drug Administration released a draft biosimilar interchangeability guidance document, something that industry has been waiting on for over a year. Biosimilar drug manufacturers will now have 60 days to [...]
A drug is approved for market use only after a clinical trial has shown that it is safe and that it effectively treats a certain condition. Once the drug is on the market, it can [...]
In 2016, countless drug companies came under fire from the public due to the high market price of their drugs. According to industry experts, one way to deal with this issue of rising costs in [...]
FDA drug approvals were at a low in 2016, with just 22 new drugs making it to market, down from 45 in 2015. This is the lowest number of approvals in a year since 2010. [...]
It’s been an exciting start to the new year for the biosimilar industry. The FDA has released a finalized guidance document for developing biosimilar drugs, which clarifies how drug makers can prove that their drug [...]
It seems more than likely that current FDA chief, Robert Califf, will be replaced when Donald Trump takes over as President later this month. He has served as chief of the agency for less than [...]