After finishing 2024 with a 15.25% decline, the BioWorld Drug Developers Index rebounded 6.93% in January, only to fall back to a modest 1.06% gain by the end of February. The Nasdaq Biotechnology Index and the Dow Jones Industrial Average followed a similar pattern, each rising about 5% by the end of January, before closing February at 3.13% and -2.48%, respectively.

The U.S. FDA approved 16 drugs in February, up from 12 in January but still falling short of the 2024 monthly average of 19 approvals. Just two of those were new molecular entities (NMEs), continuing a slower pace compared to the year’s average of slightly more than four NMEs per month.

Biopharma deal activity climbed in early 2025, reaching $37.38 billion in the first two months, up from $35.66 billion a year ago. February saw $8.76 billion in deals, down 69% from January’s $28.63 billion, which included 11 transactions valued at $1 billion or more. Early 2025 saw the second-highest biopharma deal total on record, trailing only the $42.19 billion logged in the first two months of 2022.

Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.

Yesterday’s first part of this two-part series surveyed bispecific antibodies for immunological and inflammatory (I&I) disease. Apart from bispecifics, Leerink analyst Thomas Smith lately has proven interested in I&I overall, unveiling his “five for 2025” in a January report that listed five indications with “potential for disruption” in the year ahead.

While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.