The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications.
Bluebird Bio Inc. has completed a rolling BLA filing of beta-thalassemia gene therapy beti-cel in the U.S., with analysts predicting that the Cambridge, Mass.-based biotech will have to shoot for a lower price tag after running into trouble with cost regulators in Europe.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Ivwatch, Kleiner, Welldoc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aft, Aim, Ampio, Genmab, Hyloris, Mayne, Seagen, Verrica.
Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies.
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