Regulatory Updates

The updated COVID-19 vaccine booster specifically addresses the omicron BA.4/BA.5 variants. If authorized, it will be available to ship immediately.

Novavax’s vaccine is the first protein-based COVID-19 vaccine authorized in the United States.

Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.

Recent approvals include a first generic for the infertility drug Cetrotide, as well as generics of Revatio, Velcade and Esbriet.

Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.

If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The PDUFA date is Feb 22, 2023.

Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.

Bluebird bio has set a wholesale acquisition cost of $2.8 million for the gene therapy beti-cel, now with the brand name Zynteglo, and is offering an outcomes-based contract with an 80% risk sharing.

The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.

The FDA is expected to make a decision on approval of the combination of Polivy with Rituxan and the R-CHP regimen by April 2, 2023.

If authorized, Novavax’s vaccine would be the first protein-based COVID-19 booster for adults.

The four drugs recently launched include a generic of Clindagel, which received a competitive generic therapy designation from the FDA, for acne and Vasostrict for low blood pressure.

Xofluza is a single-dose, oral therapy and is now approved for children five years and older for both the treatment and prevention of influenza.

Enhertu is the first HER2 directed drug to be approved for the treatment of patients with HER2 mutated metastatic non-small cell lung cancer.

The EUA allows Jynneos to be used in children at high risk for monkeypox and as an intradermal injection, rather than subcutaneous, for adults.

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.