Legal & Regulatory

BST02 is a novel cell-based immunotherapy currently being evaluated in a Phase I trial for the treatment of all types of liver cancer.

Duplicate rebates have resulted in revenue leakage for manufacturers.

A look at the challenges that need to be addressed during the FDA stabilization period.

FDA to evaluate Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment and with lenalidomide for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.

FDA to evaluate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.

New England Journal of Medicine study provides a breakdown of how hospitals—especially those that qualify for discounts under the federal 340B Drug Pricing Program—are able to make a profit off insurer pharmaceutical expenditures.

Breyanzi is a CD19-directed CAR T-cell therapy approved to treat multiple hematologic cancers.

Gammagard Liquid is now FDA-approved to treat neuromuscular disability and impairment in adults with CIDP; as a replacement treatment for primary immunodeficiency in patients aged 2 years and older; and as a maintenance treatment to improve muscle strength and disability in adults with multifocal motor neuropathy.

Cohort study aims to determine whether or not these regulatory changes in state government have helped reverse opioid mortality rates.

Trial data show Enhertu produced clinically meaningful and durable responses for a survival benefit in patients previously administered treatment for HER2-expressing metastatic solid tumors.

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.

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

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.

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

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

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.

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

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

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

Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.

Patients with chronic inflammatory demyelinating polyneuropathy administered HyQvia showed a statistically significant difference between relapse rates compared with placebo.

JAMA Health Forum details the DSCSA and stresses the value of protecting the pharmaceutical supply chain from adulterated products.

The list price of Casgevy for transfusion-dependent beta thalassemia has yet to be released, however, the cost for the treatment in sickle cell disease is $2.2 million.

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

Acquisition is expected to offer life sciences clients a boost in expertise and insight.

Astellas said it will work closely with the FDA and a third-party manufacturer to develop a timeline that will quickly resolve feedback from the complete response letter to a Biologics License Application for zolbetuximab.

Tivdak (tisotumab vedotin-tftv), an antibody drug conjugate, was granted accelerated approval by the FDA in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

Rinatabart sesutecan (Rina-S; PRO1184) showed encouraging antitumor activity and tolerability in patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Cretostimogene grenadenorepvec is a novel, intravesically delivered oncolytic immunotherapy under evaluation for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.

Aglatimagene besadenovec and prodrug plus chemoradiation prior to surgery was found to produce an extended and sustained survival benefit among patients with borderline resectable pancreatic ductal adenocarcinoma.