In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.
What has been the impact of COVID-19 on bio/pharmaceutical companies’ bottom line? For companies successfully bringing products for COVID-19 to fruition, 1Q 2021 results have been positive. What is expected for the rest of 2021 and beyond? DCAT...
Three-dimensional (3D) printing is an emerging technology across multiple industries, including the bio/pharmaceutical industry. To date, one drug using 3D printing has been approved by the FDA. What’s behind the technology, and what is the...
While liquid-filled hard capsules (LFHCs) have been around for decades, today’s difficult APIs and increased competition have rekindled interest in this versatile and value-added dosage form. LFHCs’ long list of advantages can have a significant...
The European Parliament formally approved last month the EU–UK pact under Brexit, which governs trade and customs issues. The pact has been applied conditionally since the beginning of 2021, but there are some concerns about its implementation....
AstraZeneca took a step forward in its $39-billion acquisition of Alexion Pharmaceuticals with approval of the deal from the US Federal Trade Commission last month. The deal, which is expected to close in the third quarter 2021, provides...
The Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America have raised concerns over recently re-introduced legislation in Congress over drug pricing. The bill includes measures for international drug...
New product development is the lifeblood of any industry. Smaller bio/pharmaceutical companies are accounting for an increasingly larger portion of new products as measured by recent new molecular entity approvals. Which companies are making the...
Continuous manufacturing is an innovative solution, providing flexibility and up to 1.65X scale-up cost savings compared to batch manufacturing.
The European Commission took another step to address ways to improve the resilience of the EU's pharmaceutical manufacturing value chain by issuing a revised roadmap for its Pharmaceutical Strategy for Europe. The revised roadmap, which is open to...
Last week (April 14, 2021), the FDA issued final guidance on remote inspections, which the FDA has used in lieu of onsite inspections due to COVID-19 restrictions. The FDA is outlining what to expect in remote inspections, including how to prepare,...
