Politics and Policy

The Vaccines and Related Biological Products Advisory Committee will hold a meeting on Sept. 22, 2022, to discuss Ferring’s RBX2660, a microbiota-based live biotherapeutic.

If approved, elacestrant would be the first oral selective estrogen receptor degrader (SERD) as a second- or third-line treatment for patients with ER+/HER2- advanced or metastatic breast cancer. The PDUFA date is Feb. 17, 2023.

Novaliq’s CyclASol uses a new technology that allows cyclosporine to be soluble without water or preservatives.

The updated PDUFA date is Feb. 28, 2023, and the planned advisory committee meeting is on hold pending review of NDA amendments.

The approval had been delayed as the regulatory agency reviewed data on Myfembree's impact on bone mineral density.

Confirmed cases of monkeypox in the United States have reached more than 7,500, according to the CDC.

Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer.

The tablet form has the same safety and efficacy as the capsule formulation and allows it to be administered with gastric-reducing therapies.

This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype. Its approval comes four months ahead of its PDUFA action date.

The committee will meet on Sept. 7, 2022, to discuss additional analyses of data from the Amylyx’s clinical studies. The updated PDUFA goal date is Sept. 29, 2022.

The FDA has requested Acadia conduct an additional trial of Nuplazid to support an indication in patients with Alzheimer’s disease.

Fresenius Kabi expects to receive FDA approval for its tocilizumab biosimilar in 2023 and is seeking approval in both intravenous and subcutaneous administration.

Results indicated the trial is unlikely to meet its primary endpoint, the change from baseline in the six-minute walk test at 24 weeks.

This is the second trial in less than a month studying Keytruda that failed to meet endpoints.

OptumRx profiles four therapies that are expecting FDA decisions in the next few months.

Stelara is the first biologic targeting both cytokines IL-12 and IL-23 and offers a therapeutic option for children six years of age and older living with active psoriatic arthritis, a rare disease.

Zoryve, the first topical PDE4 inhibitor approved to treat patients with plaque psoriasis, will be available by mid-August.

If approved, N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine would be the first immunotherapy combination for this indication in 23 years. The Prescription Drug User Fee Act target action date is May 23, 2023.

Benlysta is now the only biologic approved for adults and children who have lupus or lupus nephritis, an inflammation of the kidneys.

Kelly Stanton, director of quality at Qualio, talks about the impact on patients of prescription drug recalls.

This follows a move by Bayer to import Ultravist with non-U.S. labeling also to address pandemic-related shortages of iodine-containing contrast media used in imaging procedures.

AbbVie is seeking approval in the United States and Europe for Rinvoq to treat patients with Crohn’s disease.

If approved, Sandoz’ natalizumab would be the first biosimilar of Tysabri to treat patients with multiple sclerosis.

If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The FDA assigned a Prescription Drug User Fee Act action date of Jan. 25, 2023, but said it will hold an advisory committee meeting for this application.

If approved, Enhertu would offer a treatment option for patients with breast cancer who have a lower expression of HER2. The PDUFA action date is during the fourth quarter of the 2022.

Sandoz is seeking approval for a high-concentration formulation of Hyrimoz, which references AbbVie’s Humira.

The KEYNOTE-412 study did not meet its primary endpoint of event-free survival.

Pegcetacoplan is a targeted therapy to treat patients with age-related macular degeneration. The Prescription Drug User Fee Act (PDUFA) target action date is Nov. 26, 2022.

An independent data monitoring committee made the recommendation to stop both arms of the trial after a planned interim analysis found the trial didn’t meet its objectives.

If approved, this would be the first therapy to treat patients with Rett syndrome, a rare genetic neurological disorder mostly in girls.