The U.S. FDA approved Pfizer Inc.’s respiratory syncytial virus (RSV) prophylactic, Abrysvo (RSVpreF) for maternal use, providing pregnant women with the option of protecting their newborns up to the age of 6 months against RSV for the first time. The regulator’s Vaccines and Related Biological Products Advisory Committee voted 14-0 in favor of approving the BLA for maternal use of the vaccine in May, a few weeks before the agency gave it the go-ahead for use in older adults (those ages 60 and older).
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Anebulo, Arthrosi, Boston Immune, Bloomsbury, Canariabio, Geron, Gilead, Harvard Apparatus, Ideaya, Mycovia, Neurocrine, Phathom, Redx, Regeneron, Tonix.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Levita, Regenesis, Wenzel Spine.
The process of discovery is resource-consuming in any type of litigation, but this is especially the case for patent litigation due to the exceptional importance of attorney-client privilege in patent prosecution. However, a U.S. judicial advisory committee is considering a rewrite of the rules to ease some of this burden in a move that could cut both the expense and time consumed by patent litigation, a development that is sure to draw cheers from across the spectrum of innovators in the life sciences.
The U.S. FDA is in the midst of a shake-up of several major offices, including the Office of Regulatory Affairs, but its commissioner, Robert Califf, believes there are even greater issues faced by the agency. Califf said during an Aug. 22 public forum that prices for generic drugs are too low to encourage manufacturers to continue to produce these products, adding that the issue is sufficiently severe to constitute a national security risk.
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.
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