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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Friday morning, the FDA granted Emergency Use Authorization to both Moderna’s and Pfizer-BioNTech’s COVID-19 vaccines for use in children ages 6 months to 4 years old.
The World Trade Organization approved vaccine patent waivers to increase the availability of COVID-19 vaccines to lower-income countries.
Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant due to patient recruiting, staffing and pandemic-related issues.
Genmab and AbbVie announce positive data in large b-cell lymphoma, Intra-Cellular’s bipolar depression candidate hits the endpoint in Phase III and more.
Atreca announced that Stephen Gould, Ph.D., will be the company’s next chief scientific officer. Most recently, Gould was executive director, of Translational Oncology at Genentech.
Bavarian Nordic announced that the upcoming Phase III trial for its COVID-19 booster candidate has been redesigned to compete against licensed mRNA-based vaccines.
The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.
Speakers from Sanofi and CMIC discussed their respective experiences with DCT in Europe and Japan during Informa Connect’s Decentralized Clinical Trials hybrid meeting, held June 6-8.
Frederick National Laboratories, the American Cancer Society and other leaders are picking up the pieces - both good and bad - as COVID-19 becomes endemic.
Moderna’s study, dubbed BabyCove, is expected to begin recruiting in September and will include up to 700 babies three to six months of age.