Policy
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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The FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
Calls for a reform of drug prices have become a regular occurrence, particularly in the midst of political campaigns. Yet a new report shows the median price of a new drug launched in 2021 was $180,000.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
Novartis has fallen victim to a cyberattack. The Swiss pharma giant’s data was hijacked by a well-known online extortion ring dubbed Industrial Spy.
Data presented in bladder and pancreatic cancer at ASCO underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.
Pfizer’s Paxlovid shows benefits for vaccinated and unvaccinated patients for COVID-19, ages 65 and up while the White House indicates children under five could receive COVID vaccines by June 21.
The WHO reports it’s too early to tell if the monkeypox outbreak could become a pandemic, but believe there is a window of opportunity to control the cases.
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.