Brand & Product Security

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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.

Balversa Gets Full FDA Approval for Locally Advanced, Metastatic Urothelial Carcinoma 

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

HyQvia Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy Maintenance 

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

The Importance of Drug Supply Chain Security

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 CRISPR/Cas9 Gene-Edited Cell Therapy Casgevy for Transfusion-Dependent Beta Thalassemia

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.

Keytruda Granted Latest FDA Approval in Cervical Cancer

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

Evaluate Purchases J+D Forecasting 

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.

Astellas Pharma Issued Complete Response Letter for Zolbetuximab for GEJ Adenocarcinoma 

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.

sBLA for Tivdak Granted FDA Priority Review for Recurrent, Metastatic Cervical Cancer 

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.

FDA Fast Tracks ProfoundBio’s Novel Ovarian Cancer Treatment

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.

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