Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Biolinerx, BMS, Chiesi, Mersana, Vaxxinity.

The casual observer may be inclined to think that the European Union’s Medical Device Regulation (MDR) is off to a rocky start, but those whose livelihoods are at stake have a more intimate view of the situation. An attendee at a Sept. 12 session at this year’s Regulatory Convergence lamented what she believes is a dismal outlook for EU patients and device makers in the coming year, a testimonial that drew cheers and applause from those in attendance.

Spectrum Pharmaceuticals Inc. celebrated a long-awaited win with the U.S. FDA’s approval late Sept. 9 of novel G-CSF drug eflapegrastim, cleared for use in chemotherapy-induced neutropenia nearly four years after the company first filed for regulatory approval. Despite moves this year to reduce its cash burn, Spectrum has ready to go a commercial team expected to sell eflapegrastim as well as cancer drug poziotinib, which is under FDA review with a PDUFA date of Nov. 24, 2022.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABK Biomedical, Curvebeam AI, Haemonetics, Magbio.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pfizer.