All news articles for July 2019

(Image: Getty/greenleaf123)

New program accredits clinical research sites globally

By Melissa Fassbender

Years in the making, ACRES launches a global accreditation program, which will ‘dramatically’ benefit all research stakeholders, including sponsors, CROs, regulators, monitors, as well as patients, says CEO.

(Image: Getty/Martin Barraud)

July roundup: Regulators experience a busy month

By Ben Hargreaves

July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.

(Image: Getty/dk_photos)

PRA buys out Takeda JV in Japan

By Melissa Fassbender

PRA Health Sciences has bought out its joint venture with Takeda, establishing a new subsidiary based in Japan – a rapidly growing market, says EVP.

(Image: Getty/ipopba)

Litmus Health releases next-gen clinical research platform

By Melissa Fassbender

Litmus Health today released a new version of its end-to-end real-world data platform for clinical research – as the industry increasingly adopts wearable technology to monitor patients in their homes, says CMO.

(Image: Getty/greenleaf123)

FDA greenlights nine Lyrica generics

By Vassia Barba

Nine companies, including Teva, Alembic and Amneal receive US FDA approval for generic versions of Pfizer’s blockbuster Lyrica.

(Image: Getty/Tuomas_Lehtinen)

Parexel opens consulting subsidiary in Hong Kong

By Melissa Fassbender

Parexel’s consulting subsidiary Health Advances opens in Hong Kong to provide business strategy as well as scientific and clinical expertise to customers in the region.

(Image: Getty/Nedomacki)

FDA finds cGMP documents in Strides’ scrap yard

By Ben Hargreaves

In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.