Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration is still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens, pricing and market competition.
Government and market demands on companies and their pricing strategies have shifted dramatically in the past 10 years and the pricing landscape continues to change, creating uncertain ground beneath developers’ feet. At the BioFuture conference in New York, a panel discussed how big and small companies go about their pricing strategies and build educated guesses into how that strategy might work out in the market.
Although U.S. President Donald Trump’s Oct. 1 start date for a hefty biopharma sector tariff has come and gone, the threat remains, serving as both a stick and a carrot to get drug companies to come to the table with their best deals.
A yearslong bipartisan effort to end the patent-eligibility chaos the U.S. Supreme Court created more than a decade ago could finally come to fruition with the current Congress.
More than a decade after the last idiopathic pulmonary fibrosis (IPF) treatment gained U.S. FDA approval, Boehringer Ingelheim GmbH’s Jascayd (nerandomilast) is set to hit the market following the agency’s green light on Oct. 7. While expected to offer a modest benefit over existing therapies, Jascayd, an orally administered preferential inhibitor of phosphodiesterase 4B with breakthrough therapy status, is viewed by analysts as the first of several potential advancements in the IPF space over the next few years.
Like the federal district court before it, the U.S. Court of Appeals for the Third Circuit said it lacks jurisdiction to rule on the merits of Novo Nordisk A/S’ claim that the CMS violated the Inflation Reduction Act (IRA) when it treated six of the company’s insulin aspart products as one negotiation-eligible single-source drug.
Lexeo Therapeutics Inc. feels like it’s in a faster lane to a BLA for its Friedreich ataxia cardiomyopathy gene therapy after talking with the U.S. FDA. The agency told Lexeo that LX-2006 could be on the accelerated approval path if there is a mingling of the company’s data and studies.
Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486.
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