Brand & Product Security

Articles

Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.

Adverse Event Reports Linked to Counterfeit Ozempic on the Rise

Dupixent is now the first and only treatment option for eosinophilic esophagitis in patients aged 1 and older, weighing at least 15 kg.

Dupixent Approved for Expanded Indication in Children Under 12 Years With Eosinophilic Esophagitis 

Zynrelef was initially approved by the FDA for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

Indication for Zynrelef Expanded to Include Orthopedic, Soft Tissue Procedures

Tesamorelin (Egrifta) was initially approved by the FDA in November 2010 for the treatment of lipodystrophy in patients also diagnosed with HIV.

sBLA for New Formulation of Tesamorelin Issued Complete Response Letter by FDA

FDA adds Boxed Warning that the osteoporosis medication increases the risk for severe hypocalcemia in patients with advanced chronic kidney disease, especially among those undergoing dialysis

FDA Warns Against Risk of Hypocalcemia in Patients With Kidney Disease Taking Prolia 

Podcasts

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA). 

Complying With the DSCSA

Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. 

FDA to Require Boxed Warning Labels on CAR T-Cell Therapies for Secondary Cancer Risks

The FDA assigned Autolus Therapeutics' biologics license application for obecabtagene autoleucel with a Prescription Drug User Fee Act date of November 16, 2024.

FDA to Evaluate BLA for Obe-Cel to Treat B-Cell Acute Lymphoblastic Leukemia 

NK010, which showed promising anti-tumor activity and safety in preclinical studies, will be evaluated in a Phase I clinical trial for ovarian cancer.

FDA Clears Trial of Non-Genetically Modified Natural Killer Cell Therapy

The addressable treatment market for osteopenia is projected to reach more than $30 billion in the United States and $100 billion globally.

Legal & Regulatory