News

Demand for birth control obtained through telehealth or without a prescription continues to grow, and some states have loosened up their rules. Meanwhile, groups and organizations involved in contraception are bracing themselves for the effects of the U.S. Supreme Court decision today overturned Roe v. Wade and the constitutional right to abortion.

In COVID-19 news, the FDA expanded emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 Vaccine for children down to 6 months of age. The FDA also approved Skyrizi for Crohn’s disease, Olumiant for alopecia, as well as two rare disease therapies: Imcivree for obesity associated BBS and Amvuttra for neuropathy associated with rare disease. Additionally, FDA extended the PDUFA date Brukinsa.

In COVID-19 news, an FDA advisory committee recommends EUA for Novavax’s vaccine. The FDA has also granted approvals to Dupixent for children as young as 6 month with atopic dermatitis and to the biosimilar Riabni for rheumatoid arthritis. An advisory committee has also recommended approval for two gene therapies, one for a rare neurogenerative disease and another for a blood disease.

The commission will review PBM business practices, including the impact of rebates on formulary design, the costs of prescription drugs to patients, and methods to determine pharmacy reimbursement.

The Federal Trade Commission says its inquiry “will shed light on” clawbacks, potentially unfair audits, rebates and other business practices of the pharmacy benefits management (PBM) industry. Today’s announcement says the commission will be requiring information from the six largest PBMs.

The FDA has withdrawn the approval of Ukoniq, which is used to treat two specific types of lymphoma. In approvals, the regulatory agency has approved a new indication for Kymriah, two addition Opdivo regimens, and extended the use of Evrysdi in newborns with SMA. The agency also accepted for review Dupixent to treat skin lesions but extended the review of a new ALS therapy, refused to file an application for a rare metabolic disorder, and put a hold on the trial for Cialis OTC.

New Generic Launches

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New launches this week include: new strength of Alimta, a generic of Esbriet, a generic of Toradol, and a generic of Florinef.