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.
FEATURED STORIES
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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Icosavax posted positive topline interim data from its Phase I/Ib trial of IVX-121, its candidate virus-like particle vaccine against the respiratory syncytial virus in young and older adults.
Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
The Phase III study of Jazz Pharmaceuticals cannabis-derived MS Sativex failed to achieve the primary endpoint of an improvement in muscle tone in patients.
Roivant Sciences announced it has discontinued development of several assets following a pipeline reprioritization.
Ascletis has commenced its Phase II trial in China for its candidate drug ASC22 alongside anti-retroviral therapy for the functional cure and immune restoration of HIV-1 infection.
Boehringer and BiomX intend to use the discovery platform to identify biomarkers for a pathogenic bacterium thought to be associated with IBD.
Kezar Life Sciences stock rose 92% after it announced positive topline results from its Phase II clinical trial investigating the use of zetomipzomib for the treatment of Lupus Nephritis (LN).
The findings, presented during a poster session at the EASL 2022 International Liver Congress, revealed that of the 407 D-LIVR participants, nearly 30% developed liver cirrhosis.
Pfizer and Roivant unveiled Priovant Therapeutics to develop and market new therapies for a wide range of autoimmune diseases with high mortality and morbidity rates.
Spero Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its complicated urinary tract infection therapy, tebipenem HBr oral tablets.