The Medicare agency may eventually conduct rulemaking to standardize its new process for negotiating the prices of the highest spending drugs, a top official said Monday. Jonathan Blum, principal deputy administrator and chief operating officer at the Centers for Medicare & Medicaid Services, said the timeline Congress set in the Inflation Reduction Act (Public Law 117-169) to begin negotiating…
More cell and gene therapies will likely come to market using FDA’s accelerated approval pathway, a shift that raises concerns for the agency’s outgoing gene therapy head since it could take a while to prove definitively that they work. “If it takes years as suggested to tell if something works, then that means it takes…
The US Food and Drug Administration is eyeing potential adoption of a Project Orbis-type approach for cell and gene therapies to treat rare diseases. A process where the FDA can coordinate reviews with other regulators would allow for better leveraging of global patient populations with ultra-rare diseases and attract more commercial interest in development for…
Stakeholders should join the US Centers for Medicare and Medicaid Services in tracking the impact of the Medicare price negotiation program on drug innovation and access in order to inform any program changes that Congress may consider down the road, said Jonathan Blum, CMS principal deputy administrator and chief operating officer. Blum spoke about the…
President Joe Biden will use his State of the Union speech to unveil additional actions in the fight against cancer as part of the administration’s revived “Cancer Moonshot” initiative, which has a goal of cutting the death rate from cancer by 50% over the next 25 years. Biden will call on Congress to reauthorize the decades-old National Cancer Act to update…
President Joe Biden’s reignited moonshot to halve cancer deaths, improve care and eventually end the disease gives a lift to one of his longest-held and most personal goals — but the mission hasn’t been refueled. Missing from the ambitious plan to boost screening, reduce inequities and strengthen prevention efforts is a funding boost to the…
WASHINGTON – Today, President Biden announced his intent to appoint six members to the National Cancer Advisory Board, which plays an important role in guiding the Director of the National Cancer Institute in setting the course for the national cancer research program. The National Cancer Advisory Board will complement the Cancer Moonshot, which President Biden…
NEW YORK–(BUSINESS WIRE)–COTA, Inc., an oncology real-world data and analytics company, today announced its membership in the Clinical Research Data Sharing Alliance (CRDSA), a nonprofit, cross-industry alliance of biopharma companies, data sharing platforms, academic institutions, and service and technology partners. Member organizations collaborate to accelerate the discovery and delivery of life-saving therapies to patients through the use…
One of BIO’s top priorities is preventing FDA from routinely requiring that trials confirming clinical benefit be under way before it grants accelerated approval. Many small biotechs do not have sufficient funds to start confirmatory trials prior to approval, according to BIO. The trade association’s arguments are unlikely to resonate at the agency. FDA officials believe…
National Institutes of Health advisers proposed measures to enhance security of pathogen research, as House Republicans prepared to investigate the agency’s funding of virus experiments and handling of the Covid-19 pandemic. The NIH group recommended on Friday that federal officials expand their reviews of risky research to include any experiments altering a virus in a…
