Regulatory affairs

New EU pharma strategy looks to future-proof healthcare sector, stimulate innovation and boost access to biosimilars and generics

25-Nov-2020 By Jane Byrne

The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and...

Advarra acquires Longboat

25-Nov-2020 By Jenni Spinner

The clinical site services provider continues its series of strategic company purchases by bringing the Irish trial technologies firm under its umbrella.

FDA grants EUA for combo COVID-19 treatment

23-Nov-2020 By Jenni Spinner

The agency has given the go-ahead for use of baricitinib in conjunction with remdesivir for treating patients hospitalized with severe cases of the virus.

FDA COVID-19 news roundup this week

18-Nov-2020 By Jenni Spinner

The federal agency has offered updates, advice and action regarding the COVID-19 pandemic, helping life-sciences professionals stay on top of developments.

Latest FDA updates on COVID-19 battle

12-Nov-2020 By Jenni Spinner

As the pandemic maintains a grip on the globe, the federal agency continues to offer advice and take action to guide life-sciences professionals.

NIH: hydroxychloroquine no use to hospitalized COVID-19 patients

10-Nov-2020 By Jenni Spinner

Preliminary results from a recent clinical trial indicate the drug touted by US leaders as a possible treatment offers no significant benefit to patients.

DARPA selects continuous manufacturing partner

04-Nov-2020 By Jenni Spinner

The agency has chosen Continuity Pharma to aid in development and advancement of continuous manufacturing technology, with the help of a $1.5m grant.

CRAACO 2020

Elligo: clinical trials can learn from healthcare

30-Oct-2020 By Jenni Spinner

During the CRAACO conference, a leader from the study solutions firm will discuss how researchers can learn and benefit from the other industry.

FDA COVID-19 advice and announcements this week

28-Oct-2020 By Jenni Spinner

The latest coming from the agency includes word of the first FDA-approved treatment for the virus, template for test developers and other resources.

Saama introduces ASAP pharmacovigilance platform

27-Oct-2020 By Jenni Spinner

Built with Gilead, the RWD-based technology is designed to offer pharma firms and research partners a more effective way to verify product safety.

FDA okays first COVID-19 treatment

26-Oct-2020 By Jenni Spinner

The agency has approved the antiviral drug Veklury (remdesivir), produced by Gilead, for hospitalized patients 12 years and over diagnosed with the virus.