DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear.
The EMA issued a positive scientific opinion on Glaxosmithkline plc (GSK) and Vir Biotechnology Inc.’s sotrovimab for early COVID-19 treatment. The Committee for Human Medicinal Products (CHMP)’s opinion concerns the monoclonal antibody’s use for adolescents ages 12 and older weighing at least 40 kg (88 pounds), plus adults. All must risk progressing to severe COVID-19 and not require oxygen supplementation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Alexion, Almirall, Astrazeneca, Athenex, Bayer, Bluebird, BMS, Eli Lilly, Genmab, Glaxosmithkline, Janssen, Larimar, Moderna, Myovant Sciences, Rhythm, Takeda, Vir.
Anixa Biosciences Inc. and the Moffitt Cancer Center now have details the FDA said it needs regarding their CAR T therapy development program. The collaborators said the information can be provided to the FDA in about 30 days. The agency then has 30 days to respond.
Claiming that convicted felon Martin Shkreli continues to exert control over Vyera Pharmaceuticals LLC from prison, the U.S. Federal Trade Commission (FTC) is seeking sanctions against the former hedge fund manager for intentionally destroying text and WhatsApp messages on his company-issued phone and a contraband phone years after he was instructed to preserve all documents potentially relevant to an ongoing antitrust investigation and litigation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anixa, Everest, Gamadelta, Kintor, Mindmed, Newron, Omeros, Propella, RDIF, Sorrento, Tenaya.
Motus GI Holdings Inc. received FDA 510(k) clearance to use its Pure-Vu system in upper gastrointestinal endoscopies, expanding the system’s indications from use only in colonoscopies. Pure-Vu removes blood, blood clots and debris from the GI tract, allowing endoscopists to see sources of bleeding and other issues while leaving the endoscope's working channel available for other uses.
With the next user fee agreement negotiations underway, device makers are not keen on a substantial hike in fee volumes. Nonetheless, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, has proposed a total product life cycle (TPLC) advisory function for the next user fee agreement, something he said would bring more predictability to industry and allow the agency to interact much more routinely with device makers.