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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

The pharmaceutical packaging company unveils a new siliconization line at its SQLM plant in France.

SGD Pharma Grows Siliconized Glass Vial Capacity

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. 

A Behind-the-Scenes Look at Drug Price Markups 

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

FDA Grants Priority Review to Pair of Applications for Breyanzi for R/R Follicular Lymphoma, Mantle Cell Lymphoma

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.

Gammagard Liquid Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy 

The latest financial commitment adds 24,000 liters of biologics drug substance-capacity to the company’s network.  

AbbVie Invests an Additional $223 Million in Singapore Manufacturing Plant

SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer showing promise in the treatment of Duchenne Muscular Dystrophy patients with a confirmed exon 51-amenable mutation.

Investigational Duchenne Drug Shows Favorable Efficacy to Exondys 51 in Phase II Trial 

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

The Association Between Cannabis Legalization and Opioid Overdoses

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.

Ron Lanton, Partner, Lanton Law PLLC, Discusses New Drug Plus Pricing Models

KEYNOTE-564 is the first Phase III adjuvant trial to show improved survival for renal cancer patients at risk of recurrence after surgery following treatment with Keytruda.

Keytruda Shows 38% Improved Survival in Renal Cell Carcinoma Patients

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.

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