The Orphan Drug Act (ODA), which was passed in 1983 to incentivize drug development for rare diseases, has come under scrutiny in recent years. There are some within industry who claim that the program has been [...]
The FDA has recently initiated a pilot program which will help drug manufacturers use complex innovative trial designs (CID). This move comes after the agency committed to helping facilitate and advance the use of complex [...]
Late last month, the European Medicines Agency (EMA) released a survey to help assess pharmaceutical companies’ preparedness for Brexit. The purpose of this assessment is to identify and address any issues that could potentially disrupt [...]
President Donald Trump has recently released his budget plan, and many within the healthcare sector are disappointed to see that The Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act for short, [...]
Expanded Access Programs (EAPs), also referred to as Managed Access or Compassionate Use Programs, allow patients with no viable treatment options available to them to access investigational drugs before they are approved for market use. [...]
Over the past year, there has been a lot of talk around how to reduce prescription drug prices in the US. However, there has been little consensus on the issue, which has made passing actual [...]
House Republicans recently released a tax reform bill which would eliminate the tax credits currently awarded to drug companies for developing drugs for rare diseases. These tax credits are part of a package of incentives [...]
For years, Randomized Controlled Trials (RCTs) have been the gold standard for assessing the safety and efficacy of investigational new drugs. These trials are considered the most effective at overcoming bias and yielding high-quality evidence [...]
Last month, the European Medicines Agency (EMA) and European Union healthcare payers came together for the first time to discuss synergies for fostering timely and affordable access to medicines. The meeting took place at the [...]
Immunotherapy has become a hot topic in the oncology space over the past decade. For many cancer patients, the traditional treatment options, like chemotherapy, radiation therapy, or targeted therapies like Gleevec or Herceptin, are ineffective [...]