Drug Development
While approved by the Medicines and Healthcare products Regulatory Agency, the Alzheimer’s drug failed to win the backing of the U.K.’s National Institute for Health and Care Excellence, which said that its benefits were “too small to justify the cost.”
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Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
Experts say the time is now to develop and provide widespread access to genetic medicines for the rarest diseases. What’s more, they say it is a moral imperative.
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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.
On the heels of last week’s FDA rejection of Lykos’ MDMA-assisted PTSD therapy, Atai announced Tuesday positive preliminary results for its DMT-based treatment for depression from a Phase Ib study.
By the end of the year, Novo Nordisk intends to make a regulatory filing for the combination of its icodec and semaglutide, keeping its once-weekly insulin program afloat.
At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals.
Pfizer on Monday reported a “strong neutralizing response” against both subtypes of respiratory syncytial virus across all cohorts and age groups, according to topline data.
The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic.
A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication.
Armed with a combined $850 million in cash, the companies said Thursday the resulting biotech will have a pipeline that could deliver 10 clinical readouts over the next 18 months.