Drug Development
Cassava Sciences reported Phase II data from its Alzheimer’s candidate simufilam Tuesday. The company’s stock dropped 17% following the reveal.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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THE LATEST
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.
A roundup of last week’s top clinical trial updates and news.
Gilead’s Veklury made massive profits, but as more vaccine boosters arrive and more people become immune to the virus, the future of the antiviral is in question.
AstraZeneca topped off a very busy week with its first-quarter financial report, citing a total of $11.390 billion in revenue, a whopping increase of 60%.
The FDA approval was based on data from the Phase III Explorer-HCM trial that showed Bristol Myers Squibb’s Camzyos could decrease the heart’s contractility.
Finch Therapeutics has been given the green light to continue the Phase III Prism4 clinical trial, investigating the efficacy of CP101 in fighting recurrent C. difficile infections (CDI).
Alnylam announced another delay, this one caused by a much more sinister reason – the invasion of Ukraine, now heading into its third month and causing disruption on a multi-faceted and global scale.
Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
Pfizer says it will open the first U.S. sites in its Phase III study evaluating its investigational mini-dystrophin gene therapy in ambulatory patients with Duchenne muscular dystrophy (DMD).
Alexion shared the news that Ultomiris (ravulizumab-cwvz) has been approved by the FDA for commercialization, adding another indication for the precedent-setting drug.