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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Shares of Akero Therapeutics are surging after the company announced pharma giant Pfizer made a $25 million equity investment to support the development of the company’s experimental liver drug.
The trial evaluated crenezumab’s ability to slow Alzheimer’s disease in cognitively unimpaired people with a specific gene mutation that causes early-onset Alzheimer’s disease.
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Dr. Soon-Shiong and ImmunityBio are on the final leg of what they hope will be the FDA approval of their drug N-803 (anktiva) for the treatment of bladder cancer.
Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.
Immunic released favorable updated results for the Phase II EMPhASIS clinical trial investigating the safety and efficacy of vidofludimus calcium to treat relapsing-remitting multiple sclerosis.
Biopharma has been stepping up research and drug development against COVID-19 -though results haven’t always been encouraging. Here are the latest stories from this space:
Black/African American hematological cancer patients tend to have the worst outcomes. This is partly driven by a lack of access to allogeneic hematopoietic stem cell transplant and available donors.
The model has been validated against clinically relevant IBD therapies to demonstrate efficacy and mechanism of action, enabling drug developers to gain more accurate therapeutic insights.
In a unanimous vote, a panel of FDA advisors voted to recommend the approval of Moderna’s COVID-19 vaccine for children between the ages of six and 17 years old.