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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The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.
Speakers from Sanofi and CMIC discussed their respective experiences with DCT in Europe and Japan during Informa Connect’s Decentralized Clinical Trials hybrid meeting, held June 6-8.
Frederick National Laboratories, the American Cancer Society and other leaders are picking up the pieces - both good and bad - as COVID-19 becomes endemic.
Moderna’s study, dubbed BabyCove, is expected to begin recruiting in September and will include up to 700 babies three to six months of age.
Shares of Akero Therapeutics are surging after the company announced pharma giant Pfizer made a $25 million equity investment to support the development of the company’s experimental liver drug.
The trial evaluated crenezumab’s ability to slow Alzheimer’s disease in cognitively unimpaired people with a specific gene mutation that causes early-onset Alzheimer’s disease.
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Dr. Soon-Shiong and ImmunityBio are on the final leg of what they hope will be the FDA approval of their drug N-803 (anktiva) for the treatment of bladder cancer.
Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.
Immunic released favorable updated results for the Phase II EMPhASIS clinical trial investigating the safety and efficacy of vidofludimus calcium to treat relapsing-remitting multiple sclerosis.