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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A growing number of studies show that though natural immunity can work, hybrid immunity through vaccination could be better. They urge faster vaccination drives.
Late Thursday, Athira announced that Kawas had resigned from her position as CEO and president of the company.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
Skin health logged major wins this week after two companies announced positive clinical trial results.
Earlier this month, Catalent announced plans to add 500–600 jobs in Bloomington, Ind., one of its Moderna and Johnson & Johnson COVID-19 vaccine manufacturing sites.
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
The CDC supported the FDA’s approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.
The Pfizer-BioNTech mRNA COVID-19 vaccine is reportedly the top vaccine used globally. Here’s a look at today’s highlights.
FDA
The U.S. FDA approved the use of Moderna’s and Janssen’s COVID-19 vaccines as a booster dose after their primary versions are completed.
Winter is quickly approaching in the U.S. Vaccine makers aren’t taking a wait-and-see approach but actively preparing for what may come next.