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US Biopharma ‘Consortium’ Promises Array Of Coronavirus Remedies

 
• By Cathy Kelly

Trump Administration officials pledge support for basic science and expedited regulatory review while emphasizing the benefits that could be offered by drugs in the near term until a vaccine is developed.

White House
Biopharma At White House Meeting On Coronavirus

A group of biopharma industry executives previewed several approaches to treatments and vaccines to combat COVID-19 at a meeting with President Trump and members of the White House Coronavirus Task Force at the White House on 2 March.

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More from Vaccines

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.

‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 
• By Sarah Karlin-Smith

Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

More from Pink Sheet

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.