The latest global regulatory news, changes and updates affecting biopharma, including: Pandemic not the time for trade restrictions; Longer-term vaccine follow-up crucial; Labeling update advised for chloroquines; FDA stands up new DDT path; FDA drafts DDI guidance; MHRA continues Brexit updates; FDA debars three.
Just ahead of the U.S. celebration of Thanksgiving, the FDA granted an accelerated approval for Danyelza (naxitamab), a new therapy for certain adults and children with relapsed or refractory high-risk neuroblastoma. The antibody, which Y-mabs Therapeutics Inc. initially sublicensed via a deal with Mabvax Therapeutics Inc. in 2018, is approved for use in combination with granulocyte macrophage colony-stimulating factor. The regulator had assigned the BLA a Nov. 30 PDUFA date.<
The latest global regulatory news, changes and updates affecting biopharma, including: The other shoe drops for former Insys CEO; NICE gives nod to new myeloma regimen; MHRA prepares for January; FDA guidances finalized.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Basilea, Bio-Thera, Janssen, Liquidia, Pfizer, Polaryx, Reata, Revance, Rhovac, Sirtex.
The Pharmaceutical Research and Manufacturers Association (PhRMA) filed suit Nov. 23 in U.S. district court challenging the Trump administration’s final rule allowing the import of prescription drugs from Canada.
Four days after receiving European approval, the FDA has followed suit for Alnylam Pharmaceuticals Inc.’s Oxlumo (lumasiran), the first treatment for primary hyperoxaluria type 1, an ultra-rare genetic disorder that contributes to kidney stones and deposits.
SHENZHEN – To accelerate the development of cell therapies, China’s NMPA has introduced a dual-track regulatory pathway that allows companies to seek an IND with data from investigator-initiated trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Appili, BMS, F-star, Mustang, Obseva, Polypid, Viatris.
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