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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

New collaboration seeks to take a significant step in the development of targeted treatments for solid tumors and an expansion of opportunities in the growing antibody-drug conjugate market.

Samsung Biologics Announces Partnership With LegoChem Biosciences to Advance Development of Antibody-Drug Conjugates 

A dive into the intricacies of how to ensure a long-running event stays fresh and relevant to the needs of the pharmaceutical industry.

What Goes into Planning LogiPharma Europe?

Investigators examine the validity of phosphodiesterase type 5 inhibitors for erectile dysfunction, such as Viagra, being repurposed for the treatment of Alzheimer's disease.

Erectile Dysfunction Meds Could Be Associated With Lowering Alzheimer's Disease Risk

JNJ-2113, a novel, oral IL-23–receptor antagonist peptide showed significant efficacy in patients with moderate-to-severe plaque psoriasis compared with placebo.

Investigational Oral Therapy From Johnson & Johnson Shows Promise Treating Moderate-to-Severe Plaque Psoriasis

A study investigates the effectiveness of bivalent mRNA COVID-19 vaccines against the Omicron variant among participants 5-17 years of age. 

Determining the Efficacy of Bivalent COVID-19 Vaccines in Children and Adolescents 

The FDA placed a full clinical hold on magrolimab for hematologic cancers after data showed the drug in combination with azacitidine plus Venclexta increased the risk of death related to infections and respiratory failure in patients with acute myeloid leukemia.

Gilead Halts Development of Magrolimab in Hematologic Cancers Due to Increased Death Risk, Futility

Data suggest that dosing of MariTide may be effectively tapered down and the drug may be taken less frequently over time compared with GLP-1 agonists such as Wegovy and Zepbound.

Early Phase Trial Shows Promise of Amgen’s MariTide in Producing More Durable Weight Loss Results 

Trial for the treatment of ATTR-CM demonstrated an 81% absolute survival rate, along with an observed mean annual CVH frequency of 0.29. 

BridgeBio Pharma Receives FDA Acceptance of New Drug Application Filing for Acoramidis

The pharma powerhouse is investing $300 million in a plant that could be vital for the future cancer trials. 

AstraZeneca Unveils New Cell Therapy Manufacturing Facility in Maryland

Phase III CheckMate -77T trial data show statistically significant improvements in event-free survival with Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the treatment of resectable stage IIA to IIIB non-small cell lung cancer.  

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