Politics and Policy

Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.

If approved, lenacapavir would be the first HIV-1 treatment administered twice-yearly.

The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.

Breyanzi is now available as a second-line treatment for this aggressive blood cancer.

Generics of Viibryd, Tranxane and Timoptic have recently been approved and launched.

Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.

The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.

Increased demand for certain medications used to treat hospitalized patients with COVID-19 had a significant impact on medication supply last year.

The company will take no profit, which is part of the company’s bankruptcy filing and settlement with states.

The Cardiovascular and Renal Drugs Advisory Committee meets Nov. 16, 2022, to discuss Xphozah for patients with kidney disease.

If approved, Qulipta would be the first oral calcitonin gene-related peptide receptor antagonist with a broad preventive treatment of both chronic and episodic migraine.

Trial results showed overall survival was shorter compared with chemotherapy. The move doesn’t affect other indications.

Sierra Oncology is seeking approval of momelotinib as a treatment for patients with myelofibrosis, a bone marrow cancer.

Committee members said the data from the two trials submitted didn’t support efficacy of Nuplazid in Alzheimer’s patients. The PDUFA target date is Aug. 4, 2022.

On June 15, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of both vaccines.

This is the third approval for Skyrizi, which also treats psoriatic arthritis and plaque psoriasis.

The FDA also issued a complete response letter for Imcivree for use in patients with Alstrom syndrome, another genetic rare disease that can cause obesity.

The committee recommended Moderna’s and Pfizer’s COVID-19 vaccines were recommended for children 6 months to five years, as well as Moderna’s vaccine for children ages 7 to 16.

But investigators found that U.S. approvals often come before publication of results.

Amvuttra is expected to launch in July, and the developer, Alnylam, plans to make this available through value-based agreements.

Olumiant is the first systemic therapy available to treat alopecia.

The FDA needs time to review additional clinical data submitted by BeiGene for the leukemia/lymphoma indication. The new date is Jan. 20, 2023.

In February 2022, the FDA had issued a complete response letter in order to inspect a new third-party packaging and labeling facility.

Researchers analyzed studies from several countries and found a link between improved transitional care for those in long-term care facilities and a lower risk of a return trip to the hospital.

The FDA has set a PDUFA date of Jan. 29, 2023, but Merck indicated additional data may be provided to regulators that extends this date.