Deal-Making Roundup

whitePaper | October 14, 2022

Supply constancy, cost, sterility – even a subset of the factors that impact materials selection can be daunting for biopharmaceutical companies embarking on a new drug development project.

whitePaper | May 11, 2022

CDER is taking another step towards realizing the vision for pharmaceutical quality in the 21st century: a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.

whitePaper | March 10, 2023

In the last decade, the pharma industry has gone through significant changes in how it messages to physicians, patients and payers. The processes and tools that pharma brands use to DEVELOP and DELIVER messages have been disrupted by new technologies.

whitePaper | October 7, 2022

The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

whitePaper | December 9, 2022

Randomized, double-blind clinical trials are the gold standard for adequate and well-controlled studies in modern times. However, prior to the late 1940s, randomization and blinding were not used in medicine and as result, bias was common.

whitePaper | January 15, 2023

Oncology breakthroughs are currently fueling significant growth in the market, as well as the competition between pharmaceutical brands for market share. As increasingly individualized cancer treatments become available,