Politics and Policy

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.

Regulators have a set a date of June 15, 2024, to review new indication for Augtyro, which is already available to treat lung cancer with ROS1-positive lung and has a list price of $29,000 for a 30-day supply.

Onivyde is also approved to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

Rocket’s application for Kresladi is being extended by three months for regulators to review additional information submitted at the request of the FDA. The new Prescription Drug User Fee Act (PDUFA) date is now June 30, 2024.

Eohilia is a liquid formulation of budesonide that will be available by the end of February. It will have a wholesale acquisition cost of $1,875 per month.

The FDA has set a Prescription Drug User Fee Act target action date of Aug. 14, 2024, for seladelpar to treat adults with primary biliary cholangitis.

The FDA has set a Prescription Drug User Fee Act date of Aug. 10, 2024, for Human Acellular Vessel to repair arteries in patients with extremity vascular trauma.

The FDA had issued a complete response letter (CRL) in July 2023 for IPX203 and asked for additional pharmacokinetic data of carbidopa, one of the drugs the oral, extended release therapy.

The Prescription Drug User Fee Act date is June 7, 2024, for the additional indication of preventing respiratory syncytial virus (RSV) in adults aged 50 to 59 who are at increased risk. It is already approved for those over the age of 60.

The FDA has set an action date of Nov. 29, 2024, to review acoramidis to treat patients with transthyretin amyloid cardiomyopathy.

The Oncologic Drugs Advisory Committee will meet on March 15, 2024, to review overall survival data for Abecma in earlier lines of treatment in relapsed or refractory multiple myeloma.

Defender Pharmaceuticals is working with U.S. Naval Medical Research Unit and NASA to develop intranasal scopolamine for use in military personnel and astronauts.

Bristol Myers Squibb is seeking approval of Breyanzi, a CD19-directed CAR T-cell therapy, to treat patients with follicular lymphoma and mantle cell lymphoma.

Gammagard is an intravenous immunoglobulin therapy now approved to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.