Politics and Policy

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.

Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.

The company has received a PDUFA action date of March 11, 2022, for Adlarity, a transdermal patch for the treatment of Alzheimer’s disease.

Genentech is conducting phase 3 trials of gantenerumab, an anti-amyloid antibody.

Molnupiravir reduced the risk of hospitalization or death by about 50%.

The announcement was made by Pfizer and BioNTech on Twitter

An FDA decision is expected in late 2022.

If approved, maribavir would be the first therapy to treat transplant patients with cytomegalovirus.

Merck plans to seek emergency use authorization for molnupiravir as the first oral treatment for COVID-19.

AstraZeneca’s long-acting antibody combination has been shown to reduce the risk of developing symptomatic infection.

Data show that the vaccine was 94% effective against moderate infection and 100% effective against severe disease.

Tecartus is the first CAR T-cell therapy approved to treat adults with relapsed or refractory ALL.

Livmarli is the first drug approved for Alagille syndrome.

The company has also launched a website for patients affected by hereditary angioedema, a rare genetic disorder.

Half of the 14 oncology indications approved in the second quarter were accelerated approvals.