Drug Development
The obesity market and Most Favored Nation drug pricing were among the topics de jour at the J.P. Morgan Healthcare Conference last week, while smaller biotechs sought to assure investors that their regulatory ducks are in a row; Novo Nordisk’s oral obesity pill got off to a hot start while the FDA delayed a decision on Eli Lilly’s investigational offering; and SpyGlass Pharma and AgomAb Therapeutics join the 2026 IPO club.
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Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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BridgeBio released early data from its Phase I/II CANaspire clinical trial, indicating that BBP-812 might be a promising gene therapy for the ultra-rare Canavan disease.
PhaseBio is working toward mitigating the surgical risks for cardiac patients taking antiplatelet therapies with bentracimab, which is currently in Phase III development.
AbbVie filed a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for Qulipta for the preventative treatment of migraine.
Athira Pharma is putting a positive spin on its topline data from a Phase II trial of fosgonimeton, emphasizing positive subgroup analysis, but it missed the primary endpoint.
TC BioPharm is developing a new approach to chimeric antibody receptor (CAR) T-cell therapies with the potential to eliminate off-target effects, and possibly help more patients.
Decentralized clinical trials may cost more upfront, but can have huge returns on the back end, according to speakers at Informa Connect’s Decentralized Clinical Trials meeting.
9 Meters Biopharma is discontinuing a Phase III clinical trial for larazotide, a treatment for celiac disease as interim results were not statistically significant.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.
AstraZeneca and Ionis reported that their NEURO-TTRansform Phase III trial in hereditary transthyretin-mediated amyloid polyneuropathy hit its co-primary endpoints.