Regulatory Updates

The FDA has granted orphan drug designation to a potential first-in-class therapy for scleroderma and a PD-1 inhibitor for small cell lung cancer.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 1, 2023, for daprodustat.

The PDUFA date for Enhertu in the lung cancer indication is in the third quarter of 2022.

Generic launches include equivalents of Combigan, Abraxane, Cytotec, Solu-Medrol, and Tobradex.

The InspectIR Systems Breathalyzer test can provide results in three minutes.

Amneal's Alymsys is approved to treat several cancers.

The FDA needs to review additional data from a trial that assessed REGEN-COV for the prevention of COVID-19. The new PDUFA date is July 13, 2022.

The generic cysteine could be available after a ruling in a patent dispute, which is expected in the third quarter of 2022.

If approved, pegzilarginase would be the first treatment for ARG1 deficiency, a rare progressive disease.

The FDA had previously issued a CRL due to manufacturing issues for the therapy, which is seeking an indication for preventing infections after chemotherapy for breast cancer. The agency has set a new PDUFA date of September 9, 2022.

Igalmi is the first and only film that dissolves under the tongue that treats adults with agitation associated with schizophrenia or bipolar. BioXcel expects to launch the therapy in the second quarter of 2022.

Novartis’ Vijoice is the first approved treatment for PIK3CA-related overgrowth spectrum, a group of rare disorders.

Illuccix is approved to detect prostate cancer when using PET scan. It is available through Cardinal Health, PharmaLogic, and United Pharmacy Partners.

A phase 3 trial is expected to begin by the end of the second quarter.

The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.

Genentech also announced progress in meeting the supply challenges associated with Actemra, which is currently available under an emergency use authorization.

The FDA has asked Merck to provide to additional data from studies. The new PDUFA date is July 1, 2022.

The FDA’s final decision on AMX0035 is expected by June 29, 2022

The FDA cited safety concerns related to vadadustat, which is under review for the treatment of anemia due to chronic kidney disease.

The FDA is asking for nearly a 34% increase over the agency's fiscal year 2022 funding level.

The long-acting HIV medication is now available for those 12 years and older living with HIV-1.

Antares Pharma plans to launch Tlando, which doesn’t require dose titration, in the second quarter of 2022.

The FDA determined that the benefits of the second booster dose outweighed the risks after reviewing data from Pfizer, BioNTech, and Moderna.

Ozempic is now available in three doses to improve blood sugar in people with type 2 diabetes.

The FDA has okayed allowing patients to start treatment with the injection instead of having a lead in with the oral version.

Fintepla was approved to treat Lennox-Gastaut syndrome, which first appears in childhood and can affect neurodevelopmental, cognitive, and motor functions.

Reblozyl is being reviewed to treat anemia in patients with beta thalassemia. The new date is June 27, 2022.

Pluvicto is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.

The FDA has asked for an additional clinical trial with overall survival as the endpoint.

The CRL delays the commercial return in the United States, Takeda didn’t release any information about the reason for the CRL.