Formulary Watch |

The FDA is postponing its Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for February 15. Pfizer notified the agency about new data from its ongoing clinical trial.

Under the proposed rule, CMS would cover Aduhelm and other monoclonal antibodies for Alzheimer’s disease patients only if they are participating in approved clinical trials.

The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.

BioMatrix Specialty Pharmacy is now included as a preferred provider in AscellaHealth’s home infusion pharmacy network.

Drugs works by interfering with the classical complement pathway.

The Biosimilars Forum Board of Directors recently appointed Juliana M. Reed as its new executive director and Formulary Watch got the scoop from Reed first hand.

FDA approved the first generic version of Restasis 0.05% eye drops to increase tear production in patients whose production is suppressed due to dry eye.

Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.

The new therapy treats patients with unresectable or metastatic uveal melanoma.

Price increases on promising non–small cell lung cancer drugs despite evidence price competition raise concerns about affordability.

Regeneron Pharmaceuticals and Sanofi said they are voluntarily withdrawing their supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.

The dual orexin receptor antagonist (DORA) from a Swiss drugmaker will be available in May 2022.

More than $250 million worth of counterfeit and illegally resold versions of Gilead Sciences’ HIV medications Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) were distributed to pharmacies and patients.

The company joins the wide array of online pharmacy services, such as Amazon Pharmacy, that have popped up in recent years. Cuban has also launched a namesake PBM.

The Janssen drug is the only DOAC available in an oral suspension, which facilitates pediatric weight-based dosing.

United States healthcare spending rose 9.7% in 2020, while medication spending is increasing by more than 18%.

The FDA okayed two Janus kinase 1 (JAK1) JAK inhibitors January 14 the for atopic dermatitis: Cibinqo and Rinvoq.

In a research letter published in JAMA Health Forum, researchers say most of the cost figures for Aduhelm have left out the additional MRI scans and other services that will be required because the drug is associated with the development of amyloid-related imaging abnormalities (ARIAs).

Problems with N-nitrosodimethylamine (NDMA)-contaminated metformin were identified by the FDA in 2020. Viona Pharmaceuticals announced in earlier this month that it was recalling 23 lots of the popular diabetes medication.

Leo Pharma's Adbry (tralokinumab-ldrm) is the second, FDA-approved biologic for atopic dermatitis. Dupixent (dupilumab) was the first.

CMS has proposed covering the anti-amyloid treatment only if the person taking it is enrolled in a clinical trial.

Lecanemab and donanemab, monoclonal antibodies for Alzheimer’s, are on the list of drugs in late-stage development that Clarivate analysts will have annual sales of a $1 billion or more in the next five years.