Drug Development
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
FEATURED STORIES
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
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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.