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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9 Meters Biopharma is discontinuing a Phase III clinical trial for larazotide, a treatment for celiac disease as interim results were not statistically significant.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.
AstraZeneca and Ionis reported that their NEURO-TTRansform Phase III trial in hereditary transthyretin-mediated amyloid polyneuropathy hit its co-primary endpoints.
In the coming 12 months, Rain expects to have an interim readout for a Phase II study of its liposarcoma therapy, milademetan, and a pivotal readout for its Phase III trial of the same compound.
Thursday, a committee of advisors for the CDC voted unanimously for children and teens, ages six to 17 to receive Moderna’s COVID-19 vaccine.
CVS Health has seen about 40% patient diversity in the work it has done so far, Josh Rose, VP and head of decentralized clinical trials, site solutions and strategy told BioSpace.
Pfizer inked an Equity Subscription Agreement with France-based Valneva. They also updated their Collaboration and License deal for a Lyme disease vaccine that was announced in April.
Extension data from the Phase II TOPAZ trial showed that apitegromab yielded sustained and continued benefits in non-ambulatory patients with types 2 and 3 spinal muscular atrophy (SMA).
The FDA’s decision is based on positive results from two induction and one maintenance clinical study of AbbVie’s Skyrizi for Crohn’s disease.