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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Janssen reported analyses in which STELARA is showing promising results as a first-line therapy for Crohn’s Disease (CD) and Ulcerative Colitis (UC).
Some fear potential side effects, and more just aren’t sure about the quality and risks associated with a vaccine developed in an unprecedented nine months.
The concept is based on scientific studies showing that modulating the gut microbiome affects human health in multiple ways, beyond the expected gastrointestinal effects.
This is after the company shared positive results from its Phase III trial on Imfinzi, increasing the chances for survival in BTC patients when combined with standard-of-care chemotherapy regimens.
FDA
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.
The two Phase III studies are part of the ILLUMINATE clinical trial, which looks into the action of doravirine/islatravir (DOR/ISL) on HIV-1.
Xipere was approved for suprachoroidal use for the macular edema treatment. Macular edema is associated with uveitis, it is a form of eye inflammation.
Researchers found improvements in the study’s co-primary endpoints in patient-reported measures of esophageal inflammation and difficulty swallowing.
Novartis announced the CANOPY-1 Phase III trial of canakinumab failed to meet its primary endpoints when combined with Merck’s checkpoint inhibitor Keytruda (pembrolizumab).
It was yet another busy week for clinical trial news. Here’s a look.