Be it viral, nucleic acid or protein vaccines, recent efforts that led to the first regulatory approvals for not only COVID-19, but also for malaria and respiratory syncytial virus, positioned infectious diseases in the headlines for much of the last four years.
Be it viral, nucleic acid or protein vaccines, recent efforts that led to the first regulatory approvals for not only COVID-19, but also for malaria and respiratory syncytial virus, positioned infectious diseases in the headlines for much of the last four years. But despite that attention, or the threat of future pandemics, or the numerous infectious diseases for which there are no preventable vaccines and very little development activity, the level of private and public funding for biopharma companies working in the space is dismal – at least compared with that of oncology products, according to a new analysis report released by the Biotechnology Innovation Organization (BIO) on Jan. 25.
Nearly four years after the COVID-19 pandemic closed government offices and sent federal employees home to work remotely, the U.S. FDA is returning to some semblance of normalcy, with its drug and biologics centers expanding in-person face-to-face industry meetings to include all PDUFA and BsUFA meeting types, beginning Jan. 22.
John Crowley, a longtime industry executive whose story inspired a 2010 Hollywood movie, has been tapped for the role of president and CEO of the Biotechnology Innovation Organization (BIO), effective March 4, 2024, taking over from Rachel King, another longtime executive who has served as BIO’s interim CEO since October 2022.
With False Claims Act (FCA) whistle-blower lawsuits multiplying amid the complexity of regulations that often are unclear, the U.S. Supreme Court provided some clarity as to what constitutes a false claim in a unanimous opinion handed down June 1. But it’s not what the biopharma and med-tech industries were hoping for.
The Advanced Medical Technology Association (Advamed) and the Biotechnology Innovation Organization (BIO) have teamed up on a friend-of-the-court brief for the U.S. Supreme Court’s upcoming hearing on twin cases that examine the question of a defendant’s state of mind when filing claims with federal health programs. Advamed and BIO argue that the existing judicial approach is critical to ensuring that companies in the life sciences are not subject to treble damages when acting reasonably in connection with products reimbursed by federal health programs, adding that an overturn of existing judicial practice would stifle innovation at the cost of patient access to life-saving medical therapies.
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
A trio of proposed Medicare drug payment models that made a Feb. 14 debut in the U.S. is playing to mixed reviews. Two of the models to be tested by the U.S. Centers for Medicare & Medicaid Services (CMS) Innovation Center seem to “address the real problems underlying prescription drug pricing – patient out-of-pocket expenses and better payment systems that reward the value a medicine brings to the patient and the overall health care system,” said John Murphy, chief policy officer for the Biotechnology Innovation Organization. But he called the third model, which is expected to restrict Medicare payment for some Part B drugs that have indications with accelerated approval, “an attack on the accelerated approval pathway,” which Congress mandated to spur investment and innovation in areas of unmet medical need.
Upheaval at the Biotechnology Innovation Organization (BIO) has resulted in a sudden leadership change. Rachel King, a longtime member of the organization’s leadership and co-founder and former CEO of Glycomimetics Inc., will serve as interim president and CEO.