Leading experts in the sector explore the value of third-party logistics providers when it comes to fortifying pharmaceutical supply chains.
An analysis of the two main new models for pharmacy—unique direct—to-consumer for brands and cash pay for generics—and what members of industry think about them.
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.
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.
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.
The Federal Trade Commission and the Department of Health and Human Services are seeking public input to evaluate how policymakers can address chronic drug shortages and promote a resilient supply chain.
There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.
Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) was found to improve overall survival in metastatic pancreatic adenocarcinoma.
Properly supporting market access for a newly launched product with a single indication is challenging. Doing so for multiple indications, or supporting subsequent indications, can have a compounding effect on the degree of difficulty for getting everything right.