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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

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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. 

FDA Approves First Treatment for Multiple Food Allergies in Adults, Children 

Strategic and proactive thinking are vital in providing supply chain leaders with an opportunity to shift their focus to a more holistic, value-centered approach. 

Three Areas to Drive Supply Chain Value 

Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

FDA Grants Full Approval to Tepmetko for Metastatic NSCLC Subtype 

Personalized medicine approaches, informed by predictive modeling, could optimize treatment outcomes and reduce patient burden and costs.

Artificial Intelligence May Accelerate Time to Determine Response to Treatment

The financial commitment features construction of new warehouses in Pennsylvania and North Carolina. 

DHL Supply Chain Invests $200M Toward Expanding Its Life Sciences and Healthcare Services

The Masimo product is expected to address a significant gap in the market for dependable home-use medical devices.

First Pulse Oximeter Available Without a Prescription is Cleared by the FDA

Scientists develop algorithms that can not only identify tumors that will respond well to chemotherapy, but which are also likely to resist treatment. 

Using Machine Learning to Predict Cancer Treatment Effectiveness

Powered by evidence from the TRILUMINATE trial, Abbott's TriClip System’s benefits outweighed its risks, which led to the group’s positive recommendation.

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