Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval

Source : 'The Pink Sheet'

Half of the clinical programs awarded breakthrough therapy designations have gone on to receive FDA approval, making the BTD one of the most successful of the FDA’s expedited review pathways,...

Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021

Source : 'The Pink Sheet'

The US Food and Drug Administration breakthrough therapy designation program has granted a dozen new BTDs in 2021, including designations for seven novel agents.

As could be expected, oncology was the...

Coronavirus Notebook: WHO’s Plan For Vaccine Manufacturing In Lower-Income Countries, UK Urged To Back IP Waiver

Source : 'The Pink Sheet'

As attention increasingly focuses on making sure enough coronavirus vaccines are produced to meet global demand, the World Health Organization has announced plans for the creation of technology transfer hubs...

Emergent Suspends COVID-19 Vaccine API Manufacturing As US FDA Inspects Bayview Plant

Source : 'The Pink Sheet'

In a move that underscores the high cost of poor quality in a pandemic, Emergent BioSolutions, Inc. is suspending production of COVID-19 vaccine drug substance in the midst of...

Next EU COVID-19 Vaccine Contracts Will Take On ‘Lessons Learned’ In Capacity And Supply

Source : 'The Pink Sheet'

The EU’s negotiations on future contracts for COVID-19 vaccines will take account of “many of the lessons learned” in earlier talks regarding manufacturing capacity and delivery schedules for the vaccines,...