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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Intercept Pharmaceuticals, Annovis Bio and Biohaven Pharma are moving forward with late-stage Phase III clinical trials.
The granting of the EUA comes with certain limitations, as the prescribing pharmacist must refer patients for clinical assessment with a physician.
Lysogene’s Phase II/III trial assessing LYS-SAF302 for the treatment of MPS IIIA, also known as Sanfilippo syndrome type A, revealed positive biomarker data, spurring hope for a potential treatment.
As the global life sciences industry slows down, companies are gathering money through means other than VC funding. BioSpace shines a light on some of these recent transactions.
CytomX Therapeutics is shifting its focus to preclinical and early clinical studies, emphasizing alliances and slashing its workforce by about 40% to extend cash flow to 2025.
Mogrify and Astellas have forged a collaboration surrounding in vivo regenerative medicine approaches, while CardiNor inked a distribution deal with IBL-America.
Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.
Boehringer, Evotec and bioMérieux found Aurobac to combat antimicrobial resistance, Turnstone and Moffitt Expand TIL Collab, Skyhawk to gain potential $2B from Sanofi RNA splicing deal.
In patients stricken with ulcerative colitis for less than five years, AMT-101 was nearly three times more effective in inducing clinical remission than the placebo after eight weeks.
Findings from a study support the claim that the risk of developing a serious issue, such as respiratory or cardiac issues, is much more probable in the first 30 days following infection from COVID-19.