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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

As part of the agreement, Novo will be paid both development and commercial milestone payments for NN-8828, is currently in Phase II of non-dermatological indications. 

Almirall, Novo Nordisk Reach Licensing Agreement Surrounding IL-21 Blocking Monoclonal Antibodies

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA Accepts, Grants Priority Review to NDA for Vorasidenib in IDH-Mutant Gliomas

FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Krazati Combination for Advanced, Metastatic Colorectal Cancer Granted FDA Priority Review

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.
 


FDA Accepts Biologics License Application for Datopotamab Deruxtecan

The lack of transparency in the pharmaceutical industry further exacerbates the challenges faced by consumers. 

Navigating the Complexities of Prescription Drug Pricing: Affordable Solutions Are Available to Self-Insured Plan Sponsors

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

FDA Approves Tagrisso With Chemotherapy for EGFR-Mutated Advanced Lung Cancer

Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.

FDA Approves First One-Time, Individualized T Cell Therapy for a Solid Tumor

The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle. 

ValGenesis, RxCloud Collaborate on Tackling Compliance and Quality Assurance Challenges

The new seals include sustainable film material containing recyclate content of up to 90%.

Schreiner MediPharm Unveils New Closure Seals for Pharma Packaging

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies. 

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