Drug Development
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
FEATURED STORIES
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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Pfizer is to report initial data from a randomized trial of the second course of therapy of paxlovid in COVID-19 rebound patients by Sept. 2023.
The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
Novartis’ canakinumab failed again in non-small cell lung cancer while Anixa Biosciences, Palisade Bio and Genexine kicked off new trials.
HHS found nearly half of NIH clinical trials were reported incorrectly, in violation of federal standards, according to a new report issued Friday by the agency.
New study supports link between Alzheimer’s and other diseases and points out potential risk factors for developing Alzheimer’s later in life.
Lundbeck revealed that its migraine drug Vyepti failed to demonstrate statistical superiority over placebo at reducing the number of monthly migraine days.
The regulatory path for companies developing drugs for rare diseases is often fraught with challenges. KemPharm CEO Travis Mickle discussed just some of these with BioSpace.
Curis announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
A trial evaluating generic drugs against severe COVID-19 provided data showing their overall ineffectiveness, and COVID-19-related lawsuits continue to pile up.
South Korea-based Genuv Inc. announced the publication of a preclinical study showing the potential of Mekinist, approved by the FDA for melanoma, in Alzheimer’s disease.