Regulatory affairs

Gilead rescinds request for remdesivir orphan status

30-Mar-2020 By Jenni Spinner

The pharmaceutical company has withdrawn its orphan designation request for its antiviral for the treatment of COVID-19.

FDA grants chloroquine emergency authorization as coronavirus treatment

30-Mar-2020 By Vassia Barba

The US FDA has issued the first emergency use authorization to chloroquine phosphate and hydroxychloroquine sulfate as treatments against coronavirus.

EMA calls to scale up COVID-19 trials for conclusive data

23-Mar-2020 By Vassia Barba

The agency says the industry should prioritize large randomized controlled studies developing COVID-19 treatments, to acquire robust data.

Demand for remote clinical management explodes due to coronavirus

19-Mar-2020 By Vassia Barba

CluePoints sees demand on services supporting remote clinical trials management ‘dramatically’ increase amid the ongoing coronavirus pandemic.

FDA issues coronavirus guidance for clinical trials

19-Mar-2020 By Jenni Spinner

The document offers pointers for the industry, investigators and institutional review boards operating trials in the face of the coronavirus pandemic.

Pharma events update: rescheduled, canceled, online

18-Mar-2020 By Jenni Spinner

This list includes the industry events that have been postponed or moved because of the coronavirus pandemic.

Spaulding strikes 5-year agreement with FDA on clinical trials

16-Mar-2020 By Vassia Barba

Spaulding has been contracted by the US FDA to support clinical trials in various therapeutic areas for the following five years, starting with a $5m reward for the first year.

FDA aims to expedite coronavirus diagnostics

11-Mar-2020 By Jenni Spinner

The agency has issued a new policy intended to speed availability of diagnostic tests for the potentially deadly virus.

Judge: Feds must open trial data access

03-Mar-2020 By Jenni Spinner

A judge has ruled in favor of parties seeking to broaden access to federal clinical trial information, helping close a long-standing loophole.

Female participation up, diversity rates down in 2019 approved drugs’ trials

26-Feb-2020 By Vassia Barba

US FDA’s 2019 Drugs Trials Snapshots show female participation in clinical trials of the drugs approved during the past year increased, although ethnic diversity remains an issue.

'Significant problems' at outsourcing sites prompt Trump to plan FDA budget boost

19-Feb-2020 By Nick Taylor

President Trump proposes extra cash for US FDA to address “significant problems at many inspected outsourcing facilities.”

FDA allows research animals to enter retirement

11-Feb-2020 By Staff Reporter

Animals used in lab research can be made available for adoption, after their involvement in research at US FDA facilities.

The potential of blockchain for clinical trials

29-Jan-2020 By Ben Hargreaves

Due to the imperative for secure communication between stakeholders organizing clinical trials, a recent report suggests that blockchain technology could be a ‘perfect’ solution.

PharSafer adopts Oracle’s cloud solution for pharmacovigilance

27-Jan-2020 By Staff Reporter

The CRO will utilize the platform to provide clinical and post-marketing drug safety services to clients.

White males overrepresented in clinical trials for first-time cancer treatment

24-Jan-2020 By Ben Hargreaves

The levels of patients enrolling for a clinical trial as a first form of treatment for cancer is 0.1%, whilst also being predominantly made up of white males with private insurance.