Formulary Watch |

FDA Issues EUA for Monkeypox Vaccine for Under 18; IV Treatment on the Way

FDA Schedules Advisory Meeting for Microbiota-based C. Diff Therapy

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.

FDA Assigns Priority Review for Elacestrant in Metastatic Breast Cancer

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 Submits NDA for Dry Eye Treatment

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

Long COVID-19 a Priority for Biden Administration, Drug Developers

FDA Extends Review of Omaveloxolone in Friedreich’s Ataxia

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

FDA Approves Myfembree to Treat Endometriosis

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

FTC’s PBM Investigation Could Lead to Unintended Consequences

CivicaScript Launches Generic Abiraterone

Abiraterone is used together with prednisone to treat patients with metastatic prostate cancer.

HHS Declares Monkeypox Emergency, Expands Vaccine Distribution

FDA Approves Additional Indication for Nubeqa

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

Senate Passes Bill that Caps Insulin at $35 for Medicare Beneficiaries

FDA Approves Tablet Form of Calquence

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

FDA Approves Enhertu for HER2 Low Breast Cancer

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.

FDA Schedules Second Advisory Committee Meeting for AMX0035 in ALS

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.

FDA Issues Complete Response Letter for Nuplazid in Alzheimer’s Psychosis

FDA Accepts BLA for Biosimilar of Actemra

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

Pfizer Discontinues Late-Stage Cardiomyopathy Trial

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

CDC Adds Diagnosis Code for Rare Primary Immunodeficiency

The new code, effective Oct. 1, 2022, allows APDS to be recognized as an distinct immunological disease.

Keytruda/Lenvima Combo Fails in Liver Cancer Trial

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

Top 4 Drugs to Watch in the Third Quarter

FDA Approves First Interchangeable Biosimilar to Lucentis

Analysis Confirms High Costs Impact Adherence to Cancer Drugs

Prime Therapeutics Updates Medicare Formularies

FDA Approves Stelara in Children with Psoriatic Arthritis

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.

Optum to Offer $35 Insulin to Those without Insurance

FDA Approves Steroid-Free Zoryve for Plaque Psoriasis

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

Dr. Reddy’s Launches Prescription and Nonprescription Generics

The prescription drug launches include a therapy to treat adults with multiple myeloma and a treatment for overactive bladder. Dr. Reddy’s has also acquired several therapies from Eton Pharmaceuticals, including hypotension treatments.

Opdivo/Yervoy Combo Fails in Renal Cancer Trial

The trial of the immunotherapy combination, although approved in other renal cell carcinoma indications, did not meet the endpoint of disease-free survival in patients with localized disease.

FDA Accepts BLA for Immunotherapy for Bladder Cancer

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.