Drug Development
The Novo-Catalent deal now moving ahead highlights unprecedented investment in manufacturing, while also standing out as an exception to the unspoken rule of keeping M&As to less than $5 billion this year.
FEATURED STORIES
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use.
At a Thursday ASGCT 2024 session, CBER Director Peter Marks made the case for a better, “more convergent” global framework on cell and gene therapies, especially for rare diseases.
Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients.
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Patients taking Novo Nordisk’s blockbuster GLP-1 drug appear to be more likely to harbor thoughts of suicide or self-harm, especially if they are already suffering from anxiety or depressive disorders, according to a new study.
Eli Lilly released topline Phase III data on Tuesday showing that after more than three years of follow-up, pre-diabetic patients treated with tirzepatide were less likely to progress to type 2 diabetes.
SIGA Technologies’ TPOXX did not outperform placebo at resolving lesions in patients with clade I mpox, the new strain that has spread through parts of Africa and is reaching beyond the continent.
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.
The entry of new players and new approaches into the ATTR-CM space could help bring down the cost of treatment, experts say.
The companies’ late-stage stumble could allow Moderna to widen its lead, with its mRNA-based combination vaccine eliciting superior immune responses against COVID-19 and three influenza strains.
Lori and guests address clinical trial design, which if done without careful consideration of the patient population can exclude patients from clinical trials instead of being inclusive.
Rivus Pharmaceuticals will push HU6 into Phase III development and is looking to engage with regulatory authorities and launch a late-stage study next year in obesity-related heart failure with preserved ejection fraction.