Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Iaso, Mediwound, Moderna, Nevakar, Injectables, Skyline, Systimmune, Zealand.
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Argenx, Biomarin, Drug Farm, Madrigal, Merus, Scisparc, Unicycive, Zai Lab.
Xuanzhu Biopharmaceutical Co. Ltd., a subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., received marketing approval in mainland China for its anaprozole sodium enteric-coated tablet as a treatment of duodenal ulcer.
Two separate insider trading tips involving a biopharma acquisition and trial results for Pfizer Inc.’s COVID-19 antiviral, Paxlovid, allegedly netted millions of dollars in “ill-gotten” trading profits, according to U.S. SEC complaints announced June 29.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ausper, Bristol Myers Squibb, Can-Fite, Celltrans, Endo, Genenta, Geron, Harbour Biomed, Ipsen, Italfarmaco, Paladin Labs, Recce.
Becoming the first gene therapy approved for hemophilia A, Roctavian (valoctocogene roxaparvovec) finally received the U.S. FDA’s blessing on June 29, after developer Biomarin Pharmaceutical Inc. spent nearly three years working to address issues raised in a 2020 complete response letter. The approval came a day prior to the June 30 PDUFA date.
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease patients, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site.
One of the companies wanting to be part of the upcoming U.S. launch of Humira biosimilars is instead exploring options to raise additional capital so it can continue advancing its biosimilar pipeline in the near term. Alvotech Holdings SA, a pure-play biosimilars company based in Iceland, initially had hoped for FDA approval June 28 for AVT-02, developed as both an interchangeable and biosimilar to the high-concentration formulation (HCF) of Abbvie Inc.’s blockbuster autoimmune drug, Humira (adalimumab).
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