Articles

Lutathera is indicated for patients with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.

FDA to Review Application for Generic Lutathera for Gastroenteropancreatic Neuroendocrine Tumors 

Study investigates the gaps in access to this service, and how internet service impacts telehealth use.

Examining the Rise of Telehealth During COVID-19

Manufacturers should leverage the knowledge base of personnel working in sterility assurance and in microbiology laboratories. 

Challenges in Cell and Gene Therapy Manufacturing, Sterility Assurance

SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with relapsed or refractory acute myeloid leukemia.

FDA Grants Fast Track Designation to SLS009 for Relapsed/Refractory AML

The novel therapy in development to treat breast cancer and ovarian cancer is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s.

Shorla Oncology Announces FDA Acceptance of NDA for Novel Treatment for Breast, Ovarian Cancer

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

Evaluate Purchases J+D Forecasting 

At the 42nd annual JP Morgan Healthcare Conference, Moderna said new product launches later this year will return the company to sales growth in 2025.

Vaccine Sales Drop for Moderna in 2023 With Growth Expected by 2025

Lutikizumab is an investigational, dual-variable-domain IL 1α/1β antagonist to Phase III for the treatment of hidradenitis suppurativa.

Trial Results Show Lutikizumab Produces Higher Response Rates Treating Hidradenitis Suppurativa

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.

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