Throughout 2025, BioSpace editors observed a fast-paced news cycle in the biopharma sector, marked by regulatory changes, significant mergers and acquisitions, and controversies affecting both companies and federal agencies.
One of the most prominent stories involved a competitive acquisition process for Metsera, a biotechnology company focused on obesity treatments. Pfizer initially offered $4.9 billion to acquire Metsera, which had quickly risen to prominence after its successful initial public offering earlier in the year. However, Novo Nordisk intervened with an unsolicited bid of approximately $8.5 billion. The situation escalated into a bidding war that reached $10 billion.
Novo’s CEO Maziar Mike Doustdar stated at the White House: “Our message to Pfizer is that if they would like to buy the company, then put your hand in the pocket and bid higher.” Ultimately, Pfizer secured Metsera by matching Novo's offer and providing greater regulatory certainty due to pre-existing approval from the Federal Trade Commission. The deal closed in November following shareholder approval.
Another major story centered on Sarepta Therapeutics’ gene therapy platform for Duchenne muscular dystrophy (DMD). The company faced criticism for not disclosing a patient death linked to one of its investigational therapies until media reports surfaced. This followed earlier deaths associated with Elevidys, Sarepta’s approved DMD gene therapy. The FDA responded by pausing clinical trials and revoking Sarepta’s platform designation. Although Sarepta initially refused an FDA request to halt Elevidys shipments—citing full market approval—it later complied temporarily.
Sarepta CEO Doug Ingram explained: “because it was neither material nor central to the topics at hand.” The FDA noted it had only learned about the third death when media reports emerged, saying “it was lost in the bureaucracy.” After these events, Sarepta’s stock price fell sharply from $124 at the start of 2025 to around $20.
UniQure also drew attention after reporting three-year data showing its gene therapy AMT-130 slowed Huntington’s disease progression by 75% in a small trial. While some described this as “historic,” others cautioned against overinterpretation given past disappointments with similar treatments. UniQure planned to seek FDA approval but encountered resistance when regulators indicated that existing data might not be sufficient for licensure—a reversal from prior agreements with several biotechs this year.
Huntington’s advocate Christina DeGryse wrote: “For families who have long awaited new treatment options, the FDA’s actions feel like a serious setback and have raised urgent concerns about transparency, consistency, and trust in the regulatory process.”
Regulatory policy itself became an ongoing story throughout 2025 as frequent changes were announced via unconventional channels such as social media or editorials rather than formal guidance documents. Notable developments included new requirements for placebo-controlled vaccine trials and initiatives aimed at accelerating cell and gene therapies for rare diseases through frameworks like Rare Disease Evidence Principles introduced in September.
However, implementation questions persisted amid high turnover within senior ranks at the Food and Drug Administration (FDA), where almost 90% of leadership changed since President Donald Trump took office—prompting industry calls for more stability going into 2026.
Vaccine policy saw further upheaval under Health Secretary Robert F. Kennedy Jr., who rescinded CDC COVID-19 vaccination recommendations for certain populations via social media posts and replaced all members of a key advisory committee with individuals holding views more closely aligned with his own skepticism toward vaccines. Funding cuts totaling $500 million affected mRNA vaccine research programs previously allocated to companies such as AstraZeneca, Moderna, Pfizer and Sanofi.
After internal disagreements led to firings within CDC leadership—and following controversial moves like splitting established vaccine schedules—the agency adopted new recommendations including delaying hepatitis B vaccination for certain newborns despite longstanding safety records. Meanwhile conflicting statements about possible links between COVID-19 vaccines and pediatric deaths circulated without supporting evidence; subsequent internal reviews found no conclusive ties between vaccination and reported fatalities.
These policy shifts coincided with falling immunization rates in the U.S., resulting in decreased vaccine sales reported by major pharmaceutical firms including GSK, Pfizer, Sanofi and Merck while shares of Moderna and BioNTech declined by roughly 20% over the year due largely to these external factors affecting demand (https://www.biospace.com/article/pesky-macro-factors-aka-rfk-jr-come-for-vaccine-pharmas-wallets/).
Looking ahead into 2026, stakeholders across industry sectors are seeking greater clarity from regulators following what has been widely regarded as an unpredictable year marked by change across business operations, scientific progressions—and government oversight.
