Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
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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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Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy, while VBL received Fast Track designation for an ofra-vec combination in ovarian cancer.
How many boosters are enough to protect against COVID-19 infection? This question has been at the forefront of the minds of everyone as news crops up about yearly boosters.
Gamida Cell reported that the FDA had lifted its clinical hold on its cryopreserved formulation of GDA-201. It expects to launch a Phase I/II drug trial for those indications this year.
The war has shattered plans for a variety of clinical trials, but Roche is particularly concerned about fenebrutinib, a drug it is developing for multiple sclerosis (MS).
Protagonist Therapeutics’ Phase II study of an ulcerative colitis treatment failed to meet its primary endpoint at a higher dosage amount. Even so, the company remains optimistic about the drug’s future.
Nektar Therapeutics outlined a strategic reorganization plan that includes cutting 70% of its workforce. This comes only weeks after BMS abandoned its clinical collaboration program with Nektar.
Pfizer and its partner, Valneva, have announced positive Phase II data from its trial of vaccine candidate VLA15 in a pediatric population. VLA15 is intended to prevent Lyme Disease (LD).
Triebel holds the distinction of having discovered LAG-3 in 1990. Today, the company he founded is leveraging the handy molecule against cancer and autoimmune disease.
The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.
The DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.