In December 2019, China issued a revision to their Drug Administration Law. It was the most wide-ranging modification of their laws since 2001. It marked a fundamental shift away from…
Drug quality and strong analytical capabilities go hand-in-hand. It is virtually impossible to achieve the former without the latter at all stages of a drug’s development and production.
Coronavirus has impacted drug supply chains. At first blush, people will likely read that sentence to mean drugs aren’t arriving at their intended destination. That precursor chemicals, intermediaries, APIs, or…
The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…
According to the American Lung Association, chronic obstructive pulmonary disease (COPD – which includes chronic bronchitis and emphysema) is the third-leading cause of disease-related death in the U.S. It affects…
Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…
At just about the same time we were going to write on the state of peptides (key takeaways: yes – still growing, lots of promise, more drugs in the pipeline),…
Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…
June is Alzheimer’s and Brain Awareness Month. Alzheimer’s Disease (AD) is a heartbreaking and tragic condition affecting millions of families worldwide. This month, we highlight how health and pharma intersect….
For years, industry soothsayers have suggested the imminent demise of blockbuster drugs was upon us (here’s one from 2009 – Goodbye blockbuster medicines; hello new pharmaceutical business models). But two…