In The News
Pink Sheet – Califf Sees Potential For New Emergency Use Authorities But Concerned About Industry Follow Through
US Food and Drug Administration Commissioner Robert Califf is willing to explore emergency use authorization use outside of COVID-19-like pandemic situations, but also is concerned
Journal for ImmunoTherapy of Cancer – Regulatory implications of ctDNA in immuno-oncology for solid tumors
Abstract In the era of precision oncology, use of circulating tumor DNA (ctDNA) is emerging as a minimally invasive approach for the diagnosis and management
Bloomberg Law – Drug Price Negotiations Need ‘Nimble’ Approach, Official Says
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
Bloomberg Law – FDA Gene Therapy Head Raises Concern on Accelerated Approval Use (1)
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
Pink Sheet – US FDA Eyes Project Orbis-Type Approach For Cell And Gene Therapies
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
Pink Sheet – Medicare Price Negotiation: Data Needed To Establish ‘Unintended Consequences’ – CMS’ Blum
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
Washington Examiner – State of the Union 2023: Biden to re-up Cancer Moonshot
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
Politico – Biden’s relaunched cancer moonshot needs funding for liftoff
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
The White House – President Biden Announces Key Appointments to National Cancer Advisory Board
WASHINGTON – Today, President Biden announced his intent to appoint six members to the National Cancer Advisory Board, which plays an important role in guiding
Business Wire – COTA, Inc. Forms Strategic Real-World Data Research Partnership with the Clinical Research Data Sharing Alliance
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
