Drug Development

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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.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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Just a week after it secured FDA approval, Eli Lilly’s Zepbound now faces a challenge from Novo Nordisk’s investigational next-generation weight-loss candidate CagriSema in a Phase III trial.
This is part one of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Topics explored are ROI, human bias, data challenges, data management plans, and human expertise.
Successful drugs from Novo Nordisk and Eli Lilly are just the beginning of what one analyst says could be “the largest therapeutic class of drugs that the biopharma industry has ever seen.”
Whistleblowers allege that ZZ Biotech co-founder Berislav Zlokovic pressured his scientists to adjust data in favor of the investigational stroke therapy 3K3A-APC, according to a dossier obtained by Science.
FDA
In this episode BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss Zepbound, Wegovy, the weight loss race and the future of this drug class.
Watch this webinar to gain insights from expert speakers, Dr. Iris Alroy and Dr. Kristopher Brannan, who have made significant advancements in the field of RBPs.
When given with chemoradiotherapy, Imfinzi in a late-stage non-small cell lung cancer study did not lead to significant improvements in progression-free survival versus chemoradiotherapy alone.
In a late-stage trial, treatment with Ipsen and Genfit’s elafibranor led to high rates of biochemical response and the normalization of alkaline phosphatase levels compared with placebo.
Pennsylvania-based Aclaris Therapeutics will stop development of zunsemetinib after it failed to meet the primary endpoint in a Phase II study for rheumatoid arthritis.
At its highest dose level of 608 mg, lepodisiran reduced lipoprotein(a) levels by a median of 94% after 48 weeks.