Regulations

Digital revolution transforming drug development: West Pharma

18-Oct-2021 By Jenni Spinner

A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.

AAPS PharmSci 360

PharmSci 360 invites industry pros to ‘rethink and evolve’

14-Oct-2021 By Jenni Spinner

The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.

CDC turns to PointClickCare to gain insights from patient data

12-Oct-2021 By Jenni Spinner

The US agency plans to use the software firm’s Lighthouse technology to improve understanding of COVID-19 and other conditions in long-term care facilities.

Increasing trial diversity ‘top of mind’ for Lilly Oncology

12-Oct-2021 By Jenni Spinner

A leader from the division of Eli Lilly explains the importance of driving greater trial inclusivity, and why collaboration is vital in making progress.

Generics price fixing charges land pharma firms $447.2m penalty

05-Oct-2021 By Jenni Spinner

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations

Merck: COVID-19 oral antiviral drug reduces risk of death

01-Oct-2021 By Jenni Spinner

The pharma firm reports molnupiravir was shown to cut risk of hospitalization or death by 50% compared to placebos in a positive interim Phase III analysis.

Remarque lands patent for risk-based quality management platform

27-Sep-2021 By Jenni Spinner

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

Update on FDA COVID approvals, actions, and advice

24-Sep-2021 By Jenni Spinner

As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.

Connections, collaboration key to executing global trials: ICON

22-Sep-2021 By Jenni Spinner

A logistics leader from the CRO offers advice on navigating borders, cultures, regulatory issues and other important considerations on worldwide studies.

Rare disease clinical trials call for intelligent design: ICON

20-Sep-2021 By Jenni Spinner

Two experts from the contract research organization offer advice on planning and executing clinical studies with the unique needs of such patients in mind.

Rare-disease initiative collaborators work to advance research innovation

16-Sep-2021 By Jenni Spinner

Stakeholders in the Rare Disease Cures Accelerator-Data and Analytics Platform initiative are partnering in hopes of bringing treatments to patients faster.

FDA approves IND application for peanut allergy drug candidate

16-Sep-2021 By Jenni Spinner

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.

NIH offers $185m to further understanding of the human genome

13-Sep-2021 By Jenni Spinner

The US medical research agency plans to offer funding over five years through a newly launched consortium, expected to include 30 sites across the country.

Pfizer, Myovant announce sNDA review for endometriosis treatment

13-Sep-2021 By Jenni Spinner

The two companies are collaborating on development of Myfembree, a combination therapy to treat the painful condition affecting millions of women worldwide.

Recent FDA COVID-19 actions and updates

10-Sep-2021 By Jenni Spinner

The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike.