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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Alnylam Pharmaceuticals reported positive Phase II results for cemdisiran, an RNA interference (RNAi) drug developed to treat IgA nephropathy.
AstraZeneca reported a pre-specified pooled analysis from its Phase III trial of the diabetes drug Farxiga in patients with heart failure.
Phase III data shows the potential of Bayer’s Kerendia to reduce the risk of all-cause and cardiovascular mortality in type 2 diabetes patients with chronic kidney disease.
Factor XIa inhibitors developed by Bayer and the duo of BMS and Janssen Pharmaceuticals missed Phase II endpoints in data presented at ESC.
89bio presented positive data for pegozafermin in SHTG, Tonix enrolled its first patient with Long COVID for TNX-102, Belite enrolled patients with STGD1 and more clinical trial news.
TG Therapeutics announced the publication of Phase III trials of relapsing/remitting multiple sclerosis (RMS) drug candidate in the NEJM.
Moderna announced it is filing lawsuits against Pfizer and BioNTech, alleging that the companies’ COVID-19 vaccine infringes patents covering its mRNA technology.
Pfizer’s RSV vaccine has produced promising data with an efficacy of 85.7% in adults over 60 with a more severe form of the disease. Data in hand, Pfizer plans to head to the FDA this Fall.
Erytech Pharma is abandoning plans to submit a Biologics License Application to the FDA for Graspa in hypersensitive acute lymphoblastic leukemia.
According to a recent study, Pfizer’s Paxlovid appeared to be far more effective at reducing deaths and hospitalizations in older adults than younger patients suffering from the Omicron variant of COVID-19.