A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference.

Nearly 13 years after Congress created a biosimilars path to bring competition to the U.S. biologics market, new rules of the road are coming into play, via the Inflation Reduction Act (IRA), that could change the course for biosimilars in the long haul – if the IRA’s prescription drug price negotiation mandate withstands numerous constitutional challenges.

Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.

As Monica Bertagnolli, U.S. President Joe Biden’s choice to be the next NIH director, meets with senators to gather support for her confirmation, she’s sure to be grilled by some of them about her stance on whether the agency can march in on drug patents based on a drug’s list price. Up until now, NIH directors have said no. A change in that policy, along with nearly flatline NIH spending and other new government initiatives, could impact private investment in drug R&D by increasing the cost of research and lowering the return on investment.

The U.S. development path for rare disease treatments is strewn with numerous challenges, not least of which are the regulatory hurdles. For companies developing promising candidates to treat ultra-rare diseases and the patients who are running out of time, the regulatory obstacles in the U.S. may seem almost insurmountable. And new concerns about drug development in general could make those barriers even higher.

As several key revenue-driving products fall off patent in coming years, pharmaceutical companies are increasingly focused on mechanisms by which they can draw innovation to them. What launched as the Partner of Choice organization, for example, has now become the newly named Pfizer Ignite model – an end-to-end engine designed to bring innovation to the pharmaceutical company in return for services.

Taking aim at big pharma’s current penchant for acquisition over in-house innovation, Sen. Elizabeth Warren (D-Mass.) is asking the Federal Trade Commission (FTC) to consider the impact a biopharma merger, whether it’s proposed or a done deal, may have on future innovation.