CONGRESS gave its final approval on Tuesday to a bill that would allow patients with serious illnesses to try unproven experimental treatments, sending the measure to President Donald Trump, a strong supporter of the legislation. By a vote of 250-169, the House passed the “Right To Try” bill that was unanimously approved last August…
The U.S. House of Representatives passed a bill this week that will give terminally ill patients access to unapproved experimental drugs. President Donald Trump will likely sign it into law soon. This national “right-to-try” legislation seems like a sensible idea at first blush. Dying patients could get treatments that otherwise wouldn’t be available to…
By a vote of 250-169, the House of Representatives passed a law Tuesday aimed at expanding access by critically ill patients to therapies not yet approved by the FDA. The so-called “Right to Try” bill was approved by the Senate last August. It would allow individuals with life-threatening illnesses to obtain experimental drugs prior…
After months of debate, Congress enacted legislation yesterday that establishes a pathway for terminally ill individuals to gain access to investigational products. Even though FDA has a well-established and effective expanded access/compassionate use program that assists very ill patients in obtaining not-yet-approved therapies from sponsors, agency critics have long demanded stronger action to remove roadblocks…
The House of Representatives passed a controversial bill Tuesday night that would allow patients with life-threatening illnesses to try experimental treatments while sidestepping federal regulators. Senate Bill 204 – dubbed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act and named after patients – passed in the House with…
Tumor mutational burden (TMB) is currently being evaluated as a biomarker to predict response to immuno-oncology therapies in several studies. However, there is no agreed-upon standard for measuring TMB, with multiple companies and institutions using their own assays, which are mostly based on targeted next-generation sequencing. Two independent initiatives — one by Friends of…
The House on Tuesday passed “right to try” legislation that would allow people with life-threatening illnesses to bypass the Food and Drug Administration to obtain experimental medications, ending a drawn-out battle over access to unapproved therapies. President Trump is expected to quickly sign the measure, which was praised by supporters as a lifeline for…
Terminally ill patients would get access to experimental drugs even without the U.S. Food and Drug Administration’s permission under a measure approved by Congress that’s strongly backed by President Donald Trump. After fits and starts over the past several months, the House on Tuesday passed by a 250-169 vote a version of the bill…
Congress gave final approval on Tuesday to a bill that would allow patients with serious illnesses to try unproven experimental treatments, sending the measure to President Trump, a strong supporter of the legislation. By a vote of 250 to 169, the House passed the same “right to try” bill that was approved in August…
Trump, who forcefully pushed for the legislation in his State of the Union address and recent drug pricing speech, will likely sign the bill into law. “The Administration believes that these patients and their families should be able to seek access to potentially life-saving therapies while those treatments are still under review by the…
