Category: Europe

July 19, 2021 Off

Lonza and CN Bio in new distribution agreement

By Dino Mustafić

Through a new distribution agreement, Lonza will supply a selection of cells to be prequalified for use in CN Bio’s innovative PhysioMimixTM Organ-On-a-Chip (OOC) range of Single- and Multi-Organ Microphysiological Systems (MPS)

July 17, 2021 Off

ViiV Healthcare study shows new long-acting HIV regimen Cabenuva (cabotegravir/rilpivirine) can be successfully implemented in broad range of US healthcare practices, even during COVID-19

By BusinessWire

The study, which included people living with HIV and healthcare teams and overlapped with the COVID-19 pandemic, demonstrated that Cabenuva (a co-pack with two injectable medicines including ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine) can be successfully implemented across a range of healthcare settings in the US.

July 16, 2021 Off

EMA validates Hutchmed’s Surufatinib

By Dino Mustafić

The European Medicines Agency (EMA) has validated and accepted Chinese HUTCHMED Limited’s marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).

July 16, 2021 Off

FDA Advisory Committee: roxadustat does not support approvals in anaemia of chronic kidney disease

By Dino Mustafić

The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has reached almost unanimous vote that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult patients, and that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in CKD in dialysis-dependent (DD) adult patients.

June 14, 2021 Off

Moderna and Tabuk Pharmaceuticals Partner to Commercialize Moderna’s COVID-19 Vaccine in Saudi Arabia

By BusinessWire

-Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Tabuk Pharmaceutical Manufacturing Company (a fully owned subsidiary of Astra Industrial Group), a leading Saudi pharmaceuticals company, today announced an agreement to commercialize the Moderna COVID-19 Vaccine and future variant-specific booster candidates in Saudi Arabia.