COVID-19 Update

FDA Prioritizes Vaccine Approvals and Process Improvements; image: W.Scott McGill - stock.adobe.com

FDA Prioritizes Process Improvements

Better coordination in development and review of vaccines is needed.

Subunit Vaccines and the Fight Against COVID-19

Advances in technology are accelerating the development and manufacture of subunit vaccines.

Meeting the Demand for Lipid Excipients

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

Capitalizing on Success

November 01, 2023

Industry investments indicate increasing trust in the newest modalities, including mRNA approaches.

FDA Finalizes Guidance on Development of COVID-19 Vaccines

October 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

Phasing Out COVID-19 Regulatory Flexibilities

September 22, 2023

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Unpacking COVID-19 Pandemic Response

August 10, 2023

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

FDA Releases Updated COVID-19 Vaccine Guidelines

June 21, 2023

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA Approves Paxlovid for Treatment of COVID-19 in Adults

June 05, 2023

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Europe Lifts COVID-19 Business Continuity Status

May 10, 2023

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

FDA and Industry Prepare for End to COVID-19 Emergency

May 01, 2023

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

Crossing the Same River Multiple Times

January 02, 2023

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.