Hepatitis B vaccine(GlaxoSmithKline Plc)

iStock, quantic69 Pfizer and Metsera, Sarepta and uniQure made the list with dramatic tales. The other two spots went to the regulatory challenges facing biopharma under the new administration, especially in the vaccines sector. A constant refrain over the past year in the BioSpace newsroom chat has been, “Will this news cycle ever slow down?” Well, we sit here in late December with the answer: No. December has been anything but slow, with market-moving, hotly anticipated data still coming in, regulatory and personnel drama at the FDA and CDC, and much more keeping this little newsroom busy. The truth is, we thrive on this stuff and while we may throw up our hands from our keyboards on some mornings—and Friday afternoons—and ask the news gods, Why? , we secretly love every second of it. So going into the holiday break, the BioSpace news team took a look back at the stories we thought were the most important from 2025. These sagas intersected all of our beats, from business to clinical development to the regulatory environment. FDA FDA Policy Tracker: 2025 Was a Year of Change Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry. December 22, 2025 · 13 min read · Heather McKenzie Read More Pfizer-Metsera-Novo Bidding War Fit for Reality TV Where does one even begin with the saga that was the Metsera acquisition? Or as BMO Capital Markerts analyst Evan David Seigerman dubbed it: The Real Housewives of Biopharma . In September, Pfizer offered a cool $4.9 billion upfront plus a contingent value right to buy obesity hotshot biotech Metsera. The company debuted in 2024 to much fanfare, then met the hype with multiple clinical readouts that quickly put it as the front of the pack of up-and-comers in the ballooning weight loss space. It conducted one of the most successful IPOs of 2025 in January. The Pfizer buyout seemed on its way to closing. In regulatory filings about the deal, Metsera noted that there had been other parties interested, including one—later revealed to be Novo Nordisk—that was likely to have regulatory challenges in closing. Then Novo dropped a bomb . On October 30, the Danish pharma, desperate to replenish a flagging obesity pipeline, submitted an unsolicited bid to usurp Pfizer and buy Metsera for about $8.5 billion. A normally restrained Pfizer seemed livid, calling the offer “reckless and unprecedented.” The New York pharma quickly filed litigation against Novo, Metsera and the biotech’s shareholders. A bidding war began, with both parties upping the ante all the way to $10 billion. Novo’s CEO even called out Pfizer in an appearance 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,” Maziar Mike Doustdar said from behind a lecturn in the Oval Office. Days later, Pfizer finally secured its prize. The company matched Novo’s $10 billion bid but offered something Novo could not: certainty. Pfizer had already secured the Federal Trade Commission’s blessing. Novo was likely to take as long as two years to finalize the deal, using a framework that had already drawn antitrust concerns from the regulator. Metsera shareholders approved the deal and it closed in November, thereby capping off the most exciting biopharma M&A story in years. Obesity Is Metsera Worth the Fuss? Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: Is the obesity biotech really worth this much effort? November 5, 2025 · 4 min read · Annalee Armstrong Sarepta’s Gene Therapy Platform Causes Deaths and Drama This summer, Sarepta Therapeutics found itself in hot water with investors and the FDA after failing to disclose the death of a patient taking one of its investigational gene therapies. News of the death broke via media reports the day after the company announced a black box warning for its approved Duchenne muscular dystrophy (DMD) gene therapy Elevidys, following two earlier deaths tied to the treatment. The company also stated that it was pivoting away from the vector technology used for both gene therapies and for which Sarepta had received the first-ever FDA platform designation. Sarepta CEO Doug Ingram later told investors that the company didn’t disclose the death in this corporate update “because it was neither material nor central to the topics at hand.” Sarepta had previously reported the death to the FDA, but the agency later claimed “it was lost in the bureaucracy” and that the agency had only found out about the third death with the rest of the world. Communication mishaps aside, the FDA reacted to news of the third death by pausing clinical trials for the investigational therapy, revoking Sarepta’s platform designation and asking the company to discontinue shipments of Elevidys. To that final request—which was a request and not a demand because Elevidys has full market approval—Sarepta initially said no . But after just a few days, the company relented, and paused Elevidys shipments for all U.S. patients for 10 days . In November, the FDA made official the black box warning for Elevidys and limited its use to ambulatory patients. Sarepta’s future now hangs in the balance. After starting the year with a share price of $124, the company’s stock hit its lowest point in nearly 10 years and continues to hover around just $20. Editorial Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the regulator considers more drastic action. July 22, 2025 · 6 min read · Jef Akst UniQure Brings Hope in Huntington’s but Highlights Regulatory Woes While the Alzheimer’s and amyotrophic lateral sclerosis spaces have seen incremental breakthroughs over the past five years, patient with Huntington’s disease have continued to wander in a desert of hopelessness . Until this September. That’s when uniQure reported three-year data from a pivotal trial of its gene therapy AMT-130 showing 75% slowing of the devastating neurodegenerative disease. While small—the Phase I/II study consisted of just 29 patients—experts hailed the moment as “historic” and BBC News declared that Huntington’s had been successfully treated for the first time. Still, Ignacio Munoz-Sanjuan, CEO and chairman at Rumi Scientific and president of the Huntington’s-focused non-profit Factor-H, cautioned against communicating the results in a way that conveyed unrealistic expectations at this stage of development. The space had been here before. In an interview with BioSpace , Munoz-Sanjuan recalled a similar reaction to Roche’s tominersen when it was shown to lower mutant huntingtin (mHTT) levels in the cerebrospinal fluid in a Phase I trial. Tominersen would later fail in Phase III. Still, uniQure’s trial was considered pivotal and the company communicated plans in a Sept. 24 press release to FDA approval of AMT-130 in the first quarter of 2026, with a potential launch later next year. Five weeks later, the FDA said not so fast. On Nov. 3, following a pre-BLA meeting, uniQure revealed that the agency “no longer agrees” that the Phase I/II data for AMT-130 will be “adequate to provide the primary evidence in support of a BLA submission.” This, despite the company having aligned with the agency on the protocols and statistical analyses used. This news ultimately placed uniQure at the heart of another key story of 2025—apparent FDA 180s faced by several biotechs, including Replimune, Biohaven and Capricor Therapeutics. Since uniQure’s latest announcement, more than 10,000 Huntington’s patients, families and supporters have signed two petitions calling for the FDA to reconsider its latest guidance. “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,” Christina DeGryse, a Huntington’s disease advocate, wrote in an email to BioSpace on Nov. 16. FDA FDA Reversals Send UniQure, Biohaven, Capricor, More Into a ‘Tailspin’ Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator. November 24, 2025 · 7 min read · Heather McKenzie FDA Turmoil Creates Uncertain Regulatory Environment What is FDA policy in 2025? It’s the operational question of the year for biopharma. Proposals for regulatory changes have come via unusual channels—on social media, in media interviews and in editorials published by medical journals—often with little detail about how the new policies will be implemented. In BioSpace ’s Policy Tracker, we attempted to round up all the changes the industry has faced this year, but due to the uncertainty of these communications, it was often difficult to decide whether or not to include an initiative introduced by Commissioner Marty Makary, Center for Biologics Evaluation and Research (CBER) head Vinay Prasad or other key regulators. Promo: Policy Tracker (Notably, the CDC has faced similar challenges with communication, with former CDC Chief Medical Officer Debra Houry telling Senators that she learned of changes to the CDC’s COVID-19 vaccine guidance from an X social media post—messaging she said she could not use to implement new public health guidance.) Setting aside the unusual modes of communication, policies implemented by the FDA in 2025 have caught their share of controversy; from the requirement announced in April that all new vaccines be tested in placebo-controlled trials to the introduction of the Commissioner’s National Priority Voucher program in June—a program whose intent and feasibility has been questioned by experts . One area where industry responded with some positivity was in the cell and gene therapy space—particularly around those therapies being developed for rare and ultrarare diseases—where myriad initiatives and guidances focused on accelerating their path to the market. The FDA’s Rare Disease Evidence Principles framework, introduced in September, is intended to streamline the approval process for therapies targeting diseases affecting less than 1,000 people in the U.S., while a trio of guidances published later that month elucidated the FDA’s thinking on how to speed cell and gene therapies specifically. But many questions remain about the implementation of these and other policy changes, especially in light of unprecedented churn at the agency, which has experienced a near-complete turnover of senior leadership since Donald Trump was elected U.S. president. BioSpace learned in the spring after the forced resignation of CBER director Peter Marks that more than half of FDA leaders had left the agency since the presidential election. By December, after the sudden retirement of newly appointed CDER Director Richard Pazdur, that number was up to almost 90%. Only three names on the organizational chart from a year ago remain today. Going into 2026, industry is calling for consistency and stability at the U.S. drug regulator. Vaccines in the Cross Hairs of Health Secretary Robert F. Kennedy Jr. Observers feared that the Trump administration, along with new Health secretary and frequent vaccine opponent Robert F. Kennedy Jr., would make sweeping changes to federal vaccine policy. The administration validated that concern almost immediately. In a post on X in June, Kennedy announced that he was removing the CDC’s COVID-19 vaccination recommendation for healthy children and pregnant women. A few weeks later, he removed all 17 members of the CDC’s influential Advisory Committee on Immunization Practices, replacing them with new members more aligned with his antivaccine views. Over the summer, Kennedy also pulled back funding from vaccine research, to the tune of $500 million for mRNA-based projects. That funding would’ve gone to vaccine makers like AstraZeneca, Moderna, Pfizer and Sanofi but was pulled because “the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu,” Kennedy said in a statement from HHS, without providing evidence. The drama continued in August, as newly confirmed CDC head Susan Monarez was fired after refusing to pre-approve ACIP vaccine recommendations, she alleged. The following month, ACIP recommended splitting up the stalwart MMRV—measles, mumps, rubella and varicella (chicken pox)—shot into two separate MMR and V doses. And in its most recent meeting in December, the committee recommended delaying the hepatitis B vaccine birth dose—in use for 30 years with no prior issues—to two months post birth for babies whose mothers test negative for the virus, a move that came amid multiple condemnations from former CDC and FDA chiefs on the CDC’s policy changes. The CDC formally adopted that recommendation shortly afterward. To cap the year off, the FDA’s Vinay Prasad wrote, in a leaked internal memo, that COVID-19 vaccines had been linked to at least 10 pediatric deaths, without offering evidence. The FDA promised that that data would come soon. Soon after, news broke that the FDA planned to put a black box safety warning on COVID-19 vaccines—though in the meantime, the CDC published data showing that COVID-19 vaccines are effective at protecting children against disease. Eleven days after the FDA promised to release data relevant to Prasad’s claim, a report broke that internal research at the agency suggested the number of deaths linked to COVID-19 vaccines was between zero and seven, and that none of the seven potential deaths were conclusively tied to vaccination. The following day, Makary contradicted the reports of the FDA putting a black box warning on COVID-19 vaccines. Shares of Moderna and fellow vaccine biotech BioNTech both dropped about 20% this year, while four pharma giants— GSK , Pfizer, Sanofi and Merck—all reported declining vaccine sales due to dropping immunization rates in the U.S. Vaccines Pesky ‘Macro Factors’—aka RFK Jr.—Come for Vaccine Pharmas’ Wallets Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs. November 7, 2025 · 4 min read · Annalee Armstrong