FDA Assigns Review Date for Gene Therapy for Rare Immune Disorder
FDA has set an action date of March 31, 2024, for marnetegragene autotemcel to treat infants with a serious and often fatal immunodeficiency.
FDA Approves First Biosimilar of Arthritis Med Actemra
Biogen is still evaluating launch timeline for Tofidence, and information on pricing will be available closer to launch.
Health Plans Release 2024 Prescription Changes in Medicare Plans
Aetna, Cigna, Humana, United Healthcare — some of the largest providers of Medicare Advantage plans — have released updates to prescription drug programs.
FDA Issues CRL for Lebrikizumab in Atopic Dermatitis
At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.
FDA Approves New Pompe Therapy
The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.
FDA Sets Review Date for Odronextamab to Treat Blood Cancers
Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.
Analysis: Farxiga is a High-Value Medication for Patients with Heart Failure
The recent study also found that Jardiance for patients with heart failure with preserved ejection fraction could be cost-effective if discounted by 29%.
Cross-Contamination Leads to Recall of Two Lots of Brexafemme
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
FDA Approves Extended-Release Therapy for Major Depression
Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.
FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension
Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.
Class Action Lawsuit Filed Against CVS Caremark to Recoup DIR Fees
The class action lawsuit against CVS Health, Caremark, and Aetna was announced earlier today.
FDA Approves Drop for Drug-Induced Dilation of the Pupils
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
What We are Reading: A Pioneer in GLP-1 Research Fights for Recognition
Svetlana Mojsov, Ph.D., was a key part of the team that discovered the function of the hormone glucagon-like peptide 1 (GLP-1) and its role in diabetes and weight loss.
Preservative-free Therapy Launches to Reduce Intraocular Pressure in Glaucoma
Iyuzeh can be stored at room temperature. It has a list price of $299 for a month’s supply.
FDA Assigns Review Date for Dupixent in Young Children with Eosinophilic Esophagitis
The FDA has assigned a target action date of Jan. 31, 2024, for Dupixent to treat children 1 to 11 years of age with the inflammatory condition eosinophilic esophagitis.
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