The House voted to approve the 21st Century Cures Act, which would increase research funding, particularly for cancer, and expedite FDA reviews of drug and medical devices. Billions of dollars in new money would go to the NIH to fund research on precision medicine, cancer and neurological disorders, among other initiatives; and $1 billion in new funding would go to opioid addiction prevention and treatment programs.
Join FasterCures for a free webinar to discuss "Opportunities for the Next Administration to Advance Biomedical Innovation," on Thursday, Dec. 8, from 1 p.m. to 2 p.m. EST. Featured speakers include Patrick White, president, Act for NIH, and Mary Dwight, senior vice president for policy and patient programs, Cystic Fibrosis Foundation.
FasterCures believes the recommendations put forward by the FDA in its Proposed MDUFA IV Commitment Letter will continue to enhance and improve the device review program as a whole. In our comments, we outline three proposed enhancements that are specifically relevant to enabling the FDA to advance its efforts to deepen and expand engagement with patients, patient advocates and family caregivers. Read our full comments.
FasterCures' annual Partnering for Cures conference brings together leaders from across the research ecosystem to forge partnerships dedicated to improving health, and the event is distinctly different from other biopharmaceutical conferences, writes Rob Wright. "But because 'Partnering' succeeds in bringing together a wider range of potential collaborators, networkers have to find a common ground all on their own," he writes.
A research team at the Fred Hutchinson Cancer Research Center says it has developed a test for chronic myeloid leukemia that uses a few dime-size spots of blood on a paper card that can be submitted through the mail. The test was spawned by a summer project for high school and college students.
Clinical trials are underway on so-called weaponized antibody therapies, or antibody-drug conjugates, that deliver drugs directly to cancer cells and reduce healthy tissue damage. The approach is promising, but early versions of ADCs did not work.
Longwood Fund and Domain Associates led a Series A financing round that raised $19.15 million for Axial Biotherapeutics. The company is developing therapies licensed from the Mazmanian Lab at the California Institute of Technology that modify the patient's microbiome to treat central nervous system disorders.
The 21st Century Cures bill would change how the FDA regulates drugs, medical devices and biologic medicines; and authorizes the agency to spend $500 million over 10 years on innovation projects. The bill directs the FDA commissioner to seek input on which projects to pursue from the agency's Science Board and to submit a work plan within 180 days to specific House and Senate committees.
Policymakers worldwide must commit to building partnerships and consistently funding cancer research, experts said at an international oncology conference. "With the surge in molecular biology developments and a growing consideration for cost-benefit balance from a public health perspective, there is an increasing need to invest in cancer research and improved international partnerships to validate new targets and technologies," said Dr. Denis Lacombe, director general of the European Organisation for Research and Treatment of Cancer.
Projects to develop targeted cancer treatments will fall flat unless the scientific and health care communities change how they collect, analyze and share patient data, write Richard Hamermesh and Kathy Giusti. They co-chair the Harvard Business School Kraft Precision Medicine Accelerator, which aims to promote various efforts to break down data silos and encourage collaboration and sharing.
Treatments for HIV are safer and more effective now than on the first World AIDS Day, Dec. 1, 1988, says Dr. Joel Gallant of the Southwest Care Center. About 85% of patients who get treatment are able to manage the disease, says Dr. Michael Saag, who sat with Gallant on the panel that created treatment guidelines, and CDC data show that both diagnosis and mortality rates are down.
FasterCures is an action tank that works across sectors and diseases to improve the effectiveness and efficiency of the medical research enterprise. FasterCures, a center of the Milken Institute, is nonpartisan and independent of interest groups.
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