Pharmaceutical Commerce

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Pharmaceutical Commerce - December 2024

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Did Industry Fumble the DSCSA Deadline?

Because of the potential for product shortages at pharmacies, the FDA has not only given industry more time for compliance—but time to catch up on boosting the supply chain’s interoperable efforts.

Going Inside the Gross-to-Net Bubble and Its Nuances

A crash course on the bubble itself, including therapeutic areas most affected.

Why AI Advances in CGT Require Getting Data Right

Addressing the bottlenecks in cell and gene therapy manufacturing through a well-designed artificial intelligence approach is essential to avoiding data siloes.

Allarity Loses Rights to Cancer Drug Dovitinib After Missing Payments to Novartis

February 02, 2024

Allarity reached an agreement with Novartis in 2018 to license dovitinib, a small molecule multi-tyrosine kinase inhibitor under evaluation for the treatment of renal cell carcinoma.

Afamitresgene Autoleucel Granted FDA Priority Review for Advanced Synovial Sarcoma

February 02, 2024

Treatment with the novel engineered T-cell receptor produced an overall response rate of about 39% in patients with heavily pretreated synovial sarcoma.

Peeking Behind the Curtain: The Current State of Pharma 3PLs and Future Outlook

February 02, 2024

Leading experts in the sector explore the value of third-party logistics providers when it comes to fortifying pharmaceutical supply chains.

FDA Grants Fast Track Designation to Tumor-Infiltrating Lymphocyte Therapy for Liver Cancer

February 02, 2024

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

Forecasting the Effect of Out-of-Pocket Cost Changes for HIV Medication

February 01, 2024

Health Affairs study investigates the consequences of patient medication abandonment surrounding oral HIV pre-exposure prophylaxis.

A Pharma Pricing and Agreements Primer in Today's Complex Landscape

February 01, 2024

In order to provide both profitability and medication access, a balancing act is required.

The Impact of 340B on Commercial Contracts

February 01, 2024

Duplicate rebates have resulted in revenue leakage for manufacturers.

Newly Launched Assay May Improve Monitoring of Cancer Treatment Response

February 01, 2024

DELFI-TF assay shows promise in evaluating treatment response and resistance to immunotherapies in patients with advanced cancers.

Takeda Announces Partnership With Protagonist to Develop Novel Polycythemia Vera Drug

February 01, 2024

Rusfertide could potentially be a first-in-class, transformational treatment for polycythemia vera.

Vabysmo Shows Efficacy Improving Vision, Reducing Dryness in Retinal Vein Occlusion

February 01, 2024

Vabysmo, the first bispecific antibody approved by the FDA for ocular conditions, produced significant drying of retinal fluid, which is often associated with blurry vision.