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Pharmaceutical Commerce - December 2024

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.

Did Industry Fumble the DSCSA Deadline?

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

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

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

Why AI Advances in CGT Require Getting Data Right

Articles

A cohort study investigates how a change in clinical guidelines, an expanded label, and reduction in drug prices can impact the use of PCSK9 inhibitors as a treatment for atherosclerotic cardiovascular disease.

Analyzing PCSK9 Inhibitor Use in Adults With Cardiovascular Disease

Immune-Onc Therapeutics’ IO-202 is currently being analyzed as a monotherapy and in combination for patients with relapsed/refractory acute myeloid leukemia with monocytic differentiation or chronic myelomonocytic leukemia.

First-in-Class Novel Therapy for Chronic Myelomonocytic Leukemia Granted FDA Orphan Drug Designation 

Ocifisertib (CFI-400945) is a first-in-class, novel PLK4 inhibitor that has been found to regulate centriole duplication in patients with acute myeloid leukemia. 

FDA Grants Orphan Drug Designation to Novel Treatment for Acute Myeloid Leukemia 

OneScan 7.1 is expected to boost compliance, while also improving pharma supply chain efficiencies.  

LSPedia Introduces New Traceability Solution 

A trial set out to determine whether empagliflozin can help prevent hospitalizations and extend life for patients with heart failure, while not hurting the US payers’ pockets. 

Calculating the Cost-Effectiveness of Empagliflozin in Patients Experiencing Heart Failure 

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma 

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Phase III results from Keytruda (pembrolizumab)’s NRG-GY018 trial help influence the agency’s decision.


Merck’s Primary Advanced, Recurrent Endometrial Carcinoma Treatment Given Priority Review by FDA

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

FDA Approves Tecvayli at Reduced Dosing Frequency for Relapsed/Refractory Multiple Myeloma 

Arshad M. Khanani, MD, MA, FASRS, will help lead development efforts for sozinibercept, a potential wet AMD treatment. 

Featured Content

Pharmaceutical Commerce - December 2024

Did Industry Fumble the DSCSA Deadline?

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

Why AI Advances in CGT Require Getting Data Right