The U.S. House of Representatives is expected to pass a $6.3 billion piece of legislation on Wednesday designed to spur medical innovation, speed access to new drugs, expand mental health treatment, and combat opioid abuse. The bill, known as the 21st Century Cures Act, provides $4.8 billion to the National Institutes of Health (NIH)…
U.S. lawmakers finally reached an agreement on legislation to fund cancer research and accelerate new drugs to market. But the plan to pay for the proposal remains a sticking point for some health groups. The $6.3 billion bill, known as the 21st Century Cures Act, gets more than half its funding by revoking $3.5 billion…
Biosimilars are among the newest threads in the fabric of cancer treatment in the United States, and they are spawning numerous questions for oncologists and patients with cancer. Many of these questions were taken up by participants in a recent Washington forum on “The Future of the U.S. Biosimilars Market” sponsored by the Friends of…
Note: This press release was originally distributed by the Reagan-Udall Foundation and can be viewed HERE. November 21, 2016 – The Reagan-Udall Foundation for the FDA (RUF), an independent nonprofit organization that works to advance regulatory science to help support the scientific mission of the U.S. Food and Drug Administration (FDA), has elected Ellen…
The non-profit Reagan-Udall Foundation said it elected Ellen Sigal as chairman and Richard Schilsky as vice chair of its board of directors. Sigal, who has been acting chair since 2015, is the founder of advocacy group Friends of Cancer Research. Schilsky is SVP and CMO of the American Society of Clinical Oncology (ASCO). He has…
An FDA “Breakthrough” tag, which has been around since 2012, was once a highly coveted badge that in essence allows the regulator to help speed up development of new meds, and it was believed initially that these would be fairly rare occurrences held back for some truly innovative treatments. Now, however, the FDA seems…
The FDA backed off from a plan to issue final guidance for the regulation of laboratory developed tests (LDTs). “We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work…
Biopharmaceutical companies no longer consider FDA an obstacle to innovation and in need of major reform, according to leading observers of the drug regulatory process. “We now have clear expectations about review times,” said Jim Greenwood, president of the Biotechnology Innovation Organization (BIO), at a forum sponsored by the Bipartisan Policy Center. So we “don’t…
The head of the National Institutes of Health (NIH) is warning that plans to pass a short-term government spending bill could deal a blow to health research. NIH Director Francis Collins on Thursday called the plan for a continuing resolution (CR), which would extend current spending levels until March, “an extremely unfortunate and painful…
The head of the National Institutes of Health (NIH) warned that postponing Congressional action on major spending bills until 2017 — as GOP leaders have said they will do — puts agency programming at risk. Along with other advocates and industry representatives at a Bipartisan Policy Center briefing on Thursday, he lobbied for passing a…
