Canariabio Inc.'s MAb-AR20.5 has been awarded orphan drug designation by the FDA for pancreatic cancer. MAb-AR20.5 is an IgG1k type murine monoclonal antibody that binds specifically to the circulating and tumor-associated antigen (MUC1) expressed on pancreatic cancer cells.
Ideaya Biosciences Inc. has announced FDA clearance of an IND for a GSK-sponsored phase I/II trial of GSK-101 (IDE-705), a small-molecule inhibitor of Polϴ helicase, in combination with GSK's PARP inhibitor niraparib tosylate monohydrate for the treatment of tumors with BRCA or other homologous recombination mutations or homologous recombination deficiency.
The impact of a black box warning on Neurocrine Biosciences Inc.’s expanded U.S. label for Ingrezza (valbenazine) to treat chorea associated with Huntington’s disease (HD) appears up for debate, following FDA approval late Aug. 18. But analysts agree that it is unlikely to affect sales of the VMAT2 inhibitor in tardive dyskinesia, for which the company recently raised 2023 guidance as high as $1.82 billion.
On the heels of the U.S. FDA clearance for Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. to treat Chaple disease, the regulatory rollercoaster ride for the firm’s bid with higher-dose Eylea (aflibercept) ended with a green light for that compound as well. Eylea HD is indicated for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Calliditas, Can-Fite, Infex, Iveric,
Janssen, Leo.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Nurami Medical, Magassist.
The markets for ventricular assist devices (VADs) and intraortic balloon pumps (IABPs) are hardly littered with competition, but the few companies that work in these two device categories have faced seemingly routine recalls over the past couple of years. The U.S. FDA recently reported yet another round of class I recalls for a single model in both Abiomed Inc.’s Impella line of VADs and Datascope Corp.’s Cardiosave line of IABPs, but the agency’s apparent unwillingness to force either manufacturer to withdraw any of these recalled products seems to suggest that product shortages would quickly follow any such move on the FDA’s part.
U.S. federal preemption of state liability law for medical devices is firmly established for PMA devices, but this is not the case for devices that are cleared via the U.S. FDA‘s 510(k) program. However, some courts have gone a step further in disallowing defendants in product liability litigation from entering evidence of 510(k) clearances from the FDA, a practice that played a role in a $3.3 million verdict against Murray Hill, N.J.-based C.R. Bard Inc. that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial.
Boston Immune Technologies and Therapeutics Inc. (BITT) has received IND clearance from the FDA for a first-in-human trial of BITT-2101, a monoclonal antibody that targets tumor necrosis factor receptor 2 (TNFR2), in patients with relapsed or refractory non-Hodgkin lymphomas (NHLs).
The U.S. FDA has approved its second treatment for an ultra-rare disease in the past three days by greenlighting Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. Approval of the priority BLA for Veopoz, a fully human monoclonal antibody to treat Chaple disease, was announced two days ahead of its Aug. 20 PDUFA date. It is the only FDA-approved therapy for the indication.
RSS
