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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The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
The Centers for Medicare and Medicaid Services released details about the patient registry it will require physicians to use to prescribe Leqembi, should it be approved by the FDA.
The money saved on canceling the existing studies is intended to fund the advancement of two other oncology pipeline assets.
With an inaugural $350 million fund, Cure Ventures launched Tuesday to support early-stage companies with cutting-edge curative technologies and help them de-risk their science
Gossamer Bio announced Monday that it is discontinuing the development of its lymphoma candidate, GB5121, following two patient deaths in the Phase Ib/II STAR-CNS study.
The FDA has approved the combination regimen of Merck’s Keytruda and Seagen and Astellas’ Padcev for the first-line treatment of locally advanced or metastatic urothelial carcinoma.
With data from the Phase III trial of donanemab expected in Q2, Eli Lilly presented the first clinical results from its next anti-amyloid antibody, remternetug, at AD/PD 2023.
In a potential leap forward for sickle cell disease, Vertex moved closer to launching its one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.