President Donald Trump signed House Resolution 1, the final version of which does not impose a moratorium on state legislation governing the use of AI. The bill does, however, restore the full deductibility of research and development expenses, which will be retroactive to 2022 for businesses that gross $31 million or less per year.
A survey of members of the Bioindustry Innovation Organization (BIO) has exposed what is at stake for the sector, on both sides of the Atlantic, if proposed tariffs are imposed on pharmaceutical imports to the U.S. "A staggering 94% of biotech firms anticipate surging manufacturing costs if tariffs are placed on imports from the EU,” according to BIO.
President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services (HHS) grabbed headlines globally, but the political jostling to come will determine whether Kennedy can secure the seat.
President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services (HHS) grabbed headlines globally, but the political jostling to come will determine whether Kennedy can secure the seat.
While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
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.
