Pfizer and BioNTech have received approval for emergency use of their COVID-19 vaccine from UK regulatory authorities, making it the first COVID-19 vaccine to be approved for emergency use. What…
The COVID-19 pandemic dominated the headlines in 2020 and will again in 2021 as vaccines and treatments move through development, regulatory approval, and distribution. But what have been the other…
Viatris is the new company formed from the combination of Upjohn, Pfizer’s off-patent branded and generic established medicines business, and Mylan. The companies had announced the deal in July 2019,…
An upcoming DCAT benchmarking study is examining the lessons learned and risk-mitigation practices taken by bio/pharma companies and suppliers in the wake of the COVID-19 pandemic. What best practices can…
Biosimilars in the US: Approvals and Market Outlook
It has been 10 years since the Biologics Price Competition and Innovation Act (BPCIA) was signed into law, which authorized the regulatory pathway for biosimilars in the US. Since then,…
Challenging Years Are Ahead for the Biopharma Industry
A recent DCAT webinar, featuring Graham Lewis, Vice President, Global Pharma Strategy, IQVIA, evaluates the market impact on the COVID-19 pandemic on pharmaceutical industry performance and how fundamentals and growth…
Solid dosage products are a mainstay, but how are they faring compared to other dosage forms in terms of CDMO growth rates, product mix of new molecular entities approved thus…
US Gov’t Takes Step Forward in Plan to Re-shore Drug Manufacturing
The FDA has issued a list of 223 essential medicines as part of an executive order that directs the FDA and other agencies to develop strategies for acquiring the products…
What have been key developments thus far in 2020 impacting API sourcing, and how may that affect manufacturing networks and supply lines going forward? From plans to increase domestic drug…
