This week, it was announced that the Republicans failed to pass the American Health Care Act (AHCA), which was poised to replace Obama’s Affordable Care Act. However, this does not mean that efforts to improve [...]
The Institute for Cancer Research (ICR) in the UK is challenging current European regulations governing clinical trials in children, claiming that the out-of-date rules are limiting pediatric patients’ ability to access new cancer treatments. Under [...]
Earlier this month, the Trump administration released its budget blueprint for 2018 and announced its plans for increasing user fees paid by industry to the FDA. Industry has been paying the regulatory agency to review [...]
Earlier this month, Sanofi’s atopic dermatitis drug, dupilumab, became the latest drug to be approved for the Early Access to Medicines Scheme (EAMS) in the UK. But what exactly is the EAMS, and how do [...]
According to new rules established under the Final Rule for Clinical Trials Registration and Results Information Submission, drug companies in the US will now have to post information on expanded access on ClinicalTrials.gov, which is the [...]
In the US, seriously sick patients who have no viable treatment options available to them are able to try investigational new drugs, or drugs that are approved in other countries, as long as the drug [...]
Last month, the Food and Drug Administration (FDA) made some changes to the regulatory definitions governing off-label use of drugs in the US, and pharma groups are seriously disgruntled. A final rule was released by [...]
This week, Rare Disease Day 2017 was celebrated in over 90 countries around the world, to help raise awareness of the 350 million people currently living with a rare disease. In honor of this day, [...]
Maryland Pricing Transparency Bill - One of the biggest issues for the biopharma industry in 2016 was the growing public backlash against rising drug prices. It seems the public have had enough of drug companies [...]