Regulatory affairs

FDA approves BioMarin drug to treat dwarfism in children

22-Nov-2021 By Jenni Spinner

The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.

Pfizer inks COVID-19 treatment licensing agreement with MPP

16-Nov-2021 By Jenni Spinner

The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.

Johnson & Johnson to spin off consumer health business

12-Nov-2021 By Rachel Arthur

Johnson & Johnson has announced its intent to separate its Consumer Health business into a new publicly traded company: allowing J&J to put a sharpened focus on pharmaceuticals and medical devices.

CPHI WORLDWIDE

Pharmaceutical industry confidence on the rise: CPhI Worldwide

09-Nov-2021 By Jenni Spinner

At the open of the global pharmaceutical industry gathering, a survey of executives from around the globe indicates a rosy mood among professionals in the field.

CPhI Worldwide

Expert offers prescription for improving medicine production in Europe

02-Nov-2021 By Jenni Spinner

A leader from Medicines for Europe will share with CPhI Worldwide attendees a look at medicine production and offer solutions for elevating the industry.

CPHI WORLDWIDE

Hybrid CPhI Worldwide 2021 a ‘celebration’ of pharma industry

02-Nov-2021 By Jenni Spinner

The global pharmaceutical industry event is returning to the real world November 9-11 this year, with online content for professionals opting not to travel.

Study coordinator pleads guilty to trial data falsification

01-Nov-2021 By Jenni Spinner

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.

Gilead, Merck launch Phase II trial evaluating oral regimen for HIV-1 treatment

01-Nov-2021 By Jenni Spinner

The trial will evaluate a weekly regimen of islatravir and lnecapavir in HIV patients who are virologically suppressed while on antiretroviral therapies.

Notre Dame lab partners with Artifacts to halt substandard generics

21-Oct-2021 By Jenni Spinner

The Distributed Pharmaceutical Analysis Lab and the blockchain-based platform provider will work to prevent fake and low-quality drugs from circulating.

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.

ViiV submits FDA application for pediatric HIV treatment

07-Oct-2021 By Jenni Spinner

The HIV treatment specialist has sent an application to the agency for tolutegravir, a single-tablet treatment indicated for children living with the virus.

People on the Move: October 2021

07-Oct-2021 By Jenni Spinner

This month’s news on appointments, expansions, acquisitions and other events includes Nanoform, Elligo Health Research, Curavit, and other organizations.