Drug Development
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
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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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Centessa halted ZF874 following the report of an adverse event that involved elevated liver enzymes in a Phase I study. This is the second development program the company has stopped in as many months.
A new study on Alzheimer’s disease ties the brain’s immune response to the condition, while scientists have identified a better antibody treatment for cancer and more research news.
Panacell Biotech plans to initiate a program to investigate the use of natural killer (NK) immune cells, exosomes and brown adipose-derived stem cells to treat Long COVID.
Vyne Therapeutics’ combination therapy for atopic dermatitis failed to meet the primary endpoint in a Phase II trial, leaving the company evaluating its priorities and pipeline.
MaaT Pharma announced that the U.S. FDA has maintained the clinical hold on MaaT013, its candidate for patients with steroid-resistant acute graft-versus-host disease.
Monkeypox is spreading, COVID-19 stubbornly persists and on Tuesday, news broke of a Langya henipavirus outbreak in China.
Using Cerevance’s proprietary NNETSseq technology platform, Merck and Cerevance have partnered to identify new targets for the treatment of Alzheimer’s disease.
BeiGene and Novartis’ unresectable hepatocellular carcinoma treatment, Tislelizumab, is gaining ground as a potential treatment for advanced liver cancer.
The week started off with a clinical bang for Verona Pharma, Kodiak, AstraZeneca and Daiichi Sankyo with wins in COPD, lung cancer and macular edema respectively.
Industry executives often lament the fact that clinical trials take a long time to complete and often fail. BioSpace spoke with Tufts’ Ken Getz about possible reasons and solutions.