Politics and Policy

Tevimbra will be available in the second half of this year and is indicated as a second-line treatment of patients with esophageal squamous cell carcinoma, which is an aggressive cancer.

Breyanzi is the first CAR-T therapy to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Madrigal Pharmaceuticals is pricing Rezdiffra (resmetirom) at wholesale acquisition price of $47,400 per year.

Livmarli is now approved to treat the itching associated two different rare liver diseases: progressive familial intrahepatic cholestasis and Alagille syndrome.

The additional indication is for chhildren as young as 8 years of age with heterozygous familial hypercholesterolemia.

GA Depot is a once-monthly injection to treat patients with relapsing forms of multiple sclerosis. No information was provided for why the FDA issued a complete response letter.

The submission is for the same indications, including Xolair’s recently approved indication IgE-mediated food allergy.

It can now be used to reduce the risk of cardiovascular death, heart attack and stroke in overweight patients with heart disease.

Regulators want to discuss safety issues, as well as the phase 3 trial’s design where patients were treated based on an assessment of amyloid plaque and the inclusion of patients based on tau protein levels.

The new biosimilar, Tyenne, was approved in both an IV and a subcutaneous forms to treat inflammatory conditions such as arthritis.

Simmering tensions in the pharmacy benefit management (PBM) industry have turned into fault lines. The PBMs challenging the "big three" have formed a trade association. Purchaser coalitions want change. The head of the industry's trade group says inherent marketplace friction has spilled over into political friction.

Both Wyost and Jubbonti are interchangeable for the reference products and are approved for all of the same indications

Rybrevant is indicated to be used in combination with chemotherapy as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer.

The Prescription Drug User Fee Act action date is Aug. 28, 2024.

The FDA has set an action in December 2024 for tislelizumab — now with the brand name Tevimbra — for metastatic gastric or gastroesophageal junction cancers.

The FDA is reviewing Epkinly to treat relapsed or refractory follicular lymphoma. The target date is in August 2023.

Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.

At the moment, Simlandi (adalimumab-ryvk) has the high-concentration, citrate-free, interchangeable Humira (adalimumab) market to itself.

Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.

If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. The target action date is June 27, 2024.

Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.

Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024

If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.

Amtagvi was approved to treat patients with advanced melanoma. It is a one-time cell therapy that will be administered at authorized treatment centers and have a wholesale acquisition cost of $515,000.

The FDA has set a PDUFA date of June 21, 2024, to convert the accelerated approval to full approval and expand the labeling of the gene therapy Elevidys beyond the current use in children aged 4 and 5 with Duchenne muscular dystrophy.