BioSpace

Obesity titans Novo Nordisk and Eli Lilly characteristically kicked off 2026 in the headlines. After capping 2025 with the first-ever FDA approval of an oral GLP-1 for obesity, Novo launched its Wegovy pill on Monday, starting at $149 per month out of pocket for the lower doses. Meanwhile, all eyes are on Lilly, which expects a greenlight for orforglipron as early as March. The oral weight loss play is set to be a key aspect of a pivotal year for Lilly, which hopes to more than double its annual revenue in just a few years.   Also pulling a rabbit out of a hat just before Christmas were nine drugmakers—including Amgen, Bristol Myers Squibb, Boehringer Ingelheim—which signed Most Favored Nation drug pricing agreements with the Trump administration, likely securing their businesses against the threat of tariffs. However, drug pricing will continue to be top of mind in 2026, experts told BioSpace, as only about half of Big Pharmas have signed a deal, and small and mid-sized companies haven’t yet begun.   Another area biopharma leaders are watching with bated breath is the FDA. The overwhelming consensus from experts who spoke with BioSpace is that last year was a disaster—particularly from a workforce standpoint. Still, the agency approved 56 novel drugs, down just a tick from 2024’s 59. Advisory committees fell off considerably, in both number and concordance, however, according to a report by Jefferies, as these meetings came under scrutiny by FDA leadership.  In 2026, will the unprecedented leadership turnover—especially at CDER—settle down? Will the new rare disease and cell and gene therapy policies bear first fruits? Also on the regulatory front, the CDC has already been busy this year, axing several childhood vaccines from its recommended schedule with potential implications for biopharma companies including Pfizer and Merck.   And if there’s one area biopharma watchers anticipate even more than regulatory action, it’s M&A action. Last month, analysts shared their top targets with BioSpace, listing names like Summit Therapeutics, Apogee Therapeutics and Axsome Therapeutics. Here at BioSpace, we’ll stick with Viking.   Finally, don’t forget to check out our NextGen Class of 2026—featuring 15 biotech startups whose mission and platforms cut through a challenging environment. And make sure to join us next week when senior editor Annalee Armstrong and news editor Dan Samorodnitsky will provide dispatches from the J.P. Morgan Healthcare Conference.  

In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO at Zymeworks and Josh Smiley, president and COO at Zai Lab, about how renewed confidence is driving biotech entering 2026. As we look towards conversations that will shape this year's J.P. Morgan Healthcare Conference, the biotech industry is fueled by improving market sentiments, visible at recent meetings like Jeffries in London, and reinforced by a wave of partnerships, strategic acquisitions and Chinese collaboration that is recalibrating investor expectations.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsKenneth Galbraith, CEO, ZymeworksJosh Smiley, President and Chief Operating Officer, Zai LabDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China’s OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity.   Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots.   Pfizer CEO Albert Bourla, for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration’s sentiment on vaccines, Bourla prominsed Pfizer’s continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus.  The FDA has also granted several approvals in the past week, to Amgen, Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo. USAntibiotics also snagged a greenlight, for Augmentin XR, the first approval to be given under the agency’s new Commissioner’s National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data.   In ClinicaSpace this week, we highlighted 5 of 2025’s Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025. This past week provided a few more on each front. In the winner’s circle, Immunome’s desmoid tumor drug and and Kyverna’s CAR T for stiff person syndrome both aced pivotal trials, while Sanofi’s MS drug tolebrutinib and Gilead and Arcus’ TIGIT therapy domvanalimab each failed Phase III tests.   And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma’s Next M&A Target, and more M&A predictions for 2026.  

In this episode presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, professor of medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Department of Immunology, The Mayo Clinic; Marilyn Gellar, CEO, The Celiac Disease Foundation; and Dr. Paul Lizzul, chief medical officer, AnaptysBio, about the unmet need for effective treatments for celiac disease, the limitations of the gluten-free diet and the development of ANB033, a first-in-class CD122 antagonist designed to modulate IL-2/IL-15 signaling.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsDr. Joe Murray, Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine and Department of Immunology, The Mayo ClinicMarilyn Geller, CEO, Celiac Disease FoundationDr. Paul Lizzul, Chief Medical Officer, AnaptysBio Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Pfizer followed up its winning $10 billion bid forobesity startup Metsera by adding another molecule to its obesity cabinet, thisone from Chinese firm YaoPharma in a deal worth up to $1.9 billion licensing deal announced Tuesday. Meanwhile, Wave Life Sciences and Structure Therapeutics may have changed the weight loss landscape with early and mid-stagedata from their candidates that analysts called “very disruptive” and “highlycompetitive,” respectively.  At the FDA, the confusion and instability continuewith the retirement of agency veteran Richard Pazdur just three weeks into hisrole as CDER director. Pazdur’s exit leaves the FDA with just three veteran leaders from one year ago. The CDC similarly made headlines last week as therevamped vaccines advisory committee voted to recommend postponing the hepatitis B vaccination from birth to two months of age for some infants. Meanwhile, the Clinical Trials on Alzheimer’s Disease (CTAD)conference generated excitement in the space as Roche, Eisai and others presentednew data from their respective candidates. The star of the show was Roche’snext-gen antibody trontinemab, which lowered amyloid levels below the threshold of positivity in 92%of treated patients in a mid-stage study. Meanwhile, Eisai isdetermined to buck the losing the trend in the anti-tau space. The company’s etalanetugreduced all measurable forms of MTBR-tau243—a specific biomarker of tau tanglepathology in Alzheimer’s—in a Phase Ib/II trial, according to an oralpresentation at CTAD.  Finally, check outthis week’s deep dives in BioPharm Executive on what pharmas are learning fromthe Chinese biotech sector and how Japan’s pharma industry is setting itssights on the global market.