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…
Driven by increased biologic-based drug development and industry capacity needs, biomanufacturing is an active area of investment for CDMOs/CMOs with several large-scale expansions recently announced or underway. What CDMOs/CMOs are…
President Biden Proposes New Agency for Pharma Innovation
The Biden Administration has proposed $6.5 billion in funding to establish a new federal agency within the National Institutes of Health to drive bio/pharmaceutical innovation in areas such as cancer,…
Viatris, the new company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, is proceeding with a $1-billion restructuring initiative, which includes a…
Janet Woodcock, Acting Commissioner of the FDA, provides an update on the FDA’s inspection activity during the COVID-19 pandemic, including what new tools the agency has used for inspections, which…
Drug Pricing Reform Back on the Policy Table in the US
Congress introduced legislation last week (March 23, 2021) to lower prescription drug pricing in the US. The measures include tying US drug pricing to other industrialized countries, allowing the US…
The need to improve supply-chain resilience in wake of disruptions caused by COVID-19 has caused a re-assessment of supply chains and manufacturing networks. What role will digital tools, such as…
EU, Industry Meet for Pharma Supply-Chain Resiliency
The European Commission held a kick-off meeting of the structured dialogue process of the EU’s Pharmaceutical Strategy to address ways to improve the resilience of the EU’s pharmaceutical manufacturing value…
What were some of the key capital investments in manufacturing by the pharmaceutical majors globally in 2020 and 2021 to date? Biomanufacturing for both traditional biologics and new modalities, such…
This week (March 15, 2021), the European Council endorsed a new chemicals strategy to set a long-term vision for the European Union’s (EU) chemicals policy. It is asking the European…
