Releasing a set of principles for drug pricing reform, Sen. Ron Wyden (D-Ore.) Tuesday made the opening move in what is certain to be a complex and lengthy legislative chess match. Wyden, chairman of the...
Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) Tuesday released a discussion draft of the 21st Century Cures Act 2.0 that seeks to establish a new agency to fund breakthrough medical research, create market incentives...
Newly released details of the Biden administration’s proposed Advanced Research Projects Agency for Health map out a mission for the new entity to support breakthrough technologies and make clear that...
The Supreme Court’s decision to make all subsequent Patent Trial and Appeal Board cases subject to review by the USPTO director will change little about the inter partes review system. The inter partes review (IPR)...
Long-time opponents of Acting FDA Commissioner Janet Woodcock cited the accelerated approval of Biogen’s aducanumab for Alzheimer’s disease in letters urging President Joe Biden not to nominate her to the job on a permanent basis....
As industry continues to create “push” mechanisms to fund antimicrobial development, lawmakers in the U.S. Senate House of Representatives have reintroduced legislation that proposes complementary “pull” incentives to provide more revenue certainty on the commercial side. This...
Responding to a Government Accountability Office report on direct-to-consumer advertising of drugs, Sen. Dick Durbin (D-Ill.) and Sen. Chuck Grassley (R-Iowa) Thursday said they plan to reintroduce legislation seeking to require pharmaceutical companies to disclose...
As co-leader of a new life sciences policy and regulatory practice at DLA Piper, a law and lobbying firm, Jim Greenwood, former CEO and president of BIO and a former member of Congress, hopes to...
With uncertainty looming over the clinical benefit and cost impact of Biogen’s newly approved aducanumab, Peter Bach and Craig Garthwaite argue in a Bloomberg Opinion piece that Medicare should run...
Simply wishing that drug pricing reforms won’t happen will only lead to draconian solutions imposed upon industry that undermine the long-term interests of the U.S. public and global health. The biotech...
FDA’s Center for Drug Evaluation and Research and BIO have launched separate initiatives aimed at injecting more relevant expertise into the FDA advisory committee process and making the meetings more focused on science and less...
With the election of Paul Hastings as chair of its board of directors, BIO is signaling its determination to continue a reinvention of the trade association that started two years ago with the election of...
Questions about reimbursement and market access are on everyone’s mind now that aducanumab is approved for Alzheimer’s disease, but there’s a long road ahead to figure out how the drug and its...
The U.S. government has launched BARDA Ventures, the first foray into venture capital for HHS, with a promise to put $100 million to $1 billion to work to strengthen global health security. Biomedical Advanced Research and...
Vice President Kamala Harris Wednesday swore in Eric Lander as director of the Office of Science and Technology Policy, a role President Joe Biden has elevated to cabinet status, endowing its director...
