Regulatory Updates

Vuity, developed by Allergan, is a once-daily eye drop to treat presbyopia.

Novartis’ Scemblix was approved for previously treated patients and for those who are resistant to TKI inhibitors.

The dose is one-third of the dose given to people 12 years and older.

Some have expressed concerns about the risk of myocarditis and unknown longer-term side effects.

Novatis is seeking approval for Kymriah in adult patients with advanced follicular lymphoma.

The phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in children 5 to 11 years of age.

Seglentis’ co-crystal formulation targets four complementary pain relief mechanisms.

Xipere is delivered via an injection to the back of the eye to treat macular edema associated with uveitis, a form of eye inflammation.

Genentech’s Susvimo is a refillable implant that delivers medication continuously for up to six months.

Oncopeptides will close down its business units in the United States and Europe to focus exclusively on being a Sweden-based R&D company.

Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.

A phase 3 trial of Pfizer and BioNTech’s COVID-19 vaccine booster demonstrates an efficacy rate of 95.6%.

Tecentriq is the first cancer immunotherapy available for adjuvant treatment of non-small cell lung cancer (NSCLC).

Dr. Reddy’s received FDA approval for two strengths of lenalidomide for the treatment of patients with multiple myeloma.

AmerisourceBergen/Xcenda survey finds payers believe biosimilars provide costs savings, and they are expected to continuing contracting with manufacturers.

COVID-19 travel restrictions have hindered the FDA’s ability to inspect European manufacturing facilities for bimekizumab, which is under review for the treatment of patients with psoriasis.

ZIMHI is the second product approved by the FDA to counteract opioid, and it is a high-dose naloxone expected to be launched in the first quarter of 2022.

This low-dose formulation of Biktarvy is for younger children living with HIV.

Narsoplimab was under review at the FDA to treat a complication of stem cell transplants.

The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.

Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease.

The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.

Boehringer Ingelheim will make Cyltezo available when its commercial license begins on July 1, 2023.

The committee’s two-day meeting resulted in recommended approvals for both J&J’s and Moderna’s COVID-19 booster.

Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.

The FDA has assigned a target action date of April 13, 2022, and plans to hold an advisory committee meeting.

The committee voted unanimously to support the booster given at least six months after the second dose in the original vaccine.

This is the first anti-PD-1 combination approved for patients with persistent, recurrent or metastatic cervical cancer.

The FDA has approved Tavneos, a first-in-class, oral therapy to treat a group of autoimmune diseases characterized by inflammation and damage to small blood vessels.

Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.