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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Owkin and BMS signed a deal to utilize Owkin’s artificial intelligence capabilities to carry out more targeted and efficient clinical trials on a wide range of therapeutic candidates.
Following a marathon session of the FDA’s Cell, Tissue and Gene Therapies Advisory Committee, bluebird bio passed its first critical hurdle in approval for the lentiviral vector gene therapy, eli-cel.
Cemdisiran, an RNAi mono-therapeutic intended to treat IgAN is poised to enter Phase III clinical studies after positive Phase II topline results were shared Thursday morning.
The annual meeting of the American Headache Society (AHS) is being held in Denver, Colorado from June 9-12. Here’s a look at just some of the wide-ranging research being presented.
The FDA plans to review changes to Novavax’s manufacturing process before it authorizes its vaccine.
Seelos Therapeutics announced in vitro data Thursday supporting its gene therapy, SLS-004. SLS-004 is intended for the treatment of dementia with Lewy bodies (DLB).
COVID-19 is turning out to be a particularly tenacious disease. And researchers are starting to understand why. Also, a new study found that COVID-19 deaths were higher in Republican-voting counties.
Takeda announced results from its Phase III clinical trial on TAK-003, its dengue fever vaccine candidate, at the Northern European Conference of Travel Medicine.
Precision BioSciences’ clinical program exploring allogeneic CAR T therapy may well produce a market pioneer after initial data showed its ability to deliver a 100% overall response rate.
Mineralys Therapeutics, a clinical-stage biopharmaceutical company focused on developing a best-in-class, novel therapy for high blood pressure, closed a $118 million Series B investment round.