BioSpace

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.

Momentum is building behind New Approach Methodologies (NAMs) that offer stronger human relevance than traditional animal testing. The FDA issued on December 2 a draft guidance outlining specific product types for which the agency believes six-month non-human primate toxicity testing can be eliminated or reduced.  The guidance followed a proposed agency template for NAMs in April. There is also an initiative called the Validation and Qualification Network, with dozens of partners from regulators, like the FDA and European Commission, to Big Pharmas and CROs, such as Sanofi, Novo Nordisk, GSK and Charles River Laboratories, that had a July meeting. In addition, Reuters reported in September that AI-driven drug discovery picks up as FDA pushes to reduce animal testing.In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for NAMs development.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsPatrick Smith, Senior Vice President, Translational Science, CertaraStacey Adam, PhD, Vice President of Science Partnerships, Foundation for the National Institutes of HealthDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.