Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline.
Caught between the rock and the hard place of most-favored nation (MFN) pricing and the threat of a hefty biopharma sector tariff, drug companies marketing in the U.S. are exploring their options. Several large firms already have committed millions and billions of dollars in investment in new or expanded U.S.-based manufacturing facilities to avoid tariffs on finished drugs.
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.
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.
Johnson & Johnson Medtech won out over a jury verdict that found the company’s Depuy Synthes liable for $20 million for infringing a patent claimed by Rasmussen Instruments LLC.
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.
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.
While the final word has yet to be written, Stryker Corp. came out the biggest winner in a dispute involving four related patents owned by Osteomed LLC, part of Colson Associates’ Acumed.
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.
